León Research, following the recommendations of each Government and the Competent Health Authorities of each country, wants to convey to its workers, clients and suppliers the latest modifications to the organizational measures agreed by the Direction and the contingency committee, as well as those applied to guarantee safety and health of its workers, and the continuity of the activities it performs.

The set of measures described below will be periodically modified according to the most updated recommendations of the Authorities of each country.

General Measures February 23rd, 2021

Operational measures

We will follow the guidelines issued by the Competent Regulatory Authorities for the management of clinical trials during COVID-19. These guides from both the EMA and CA of each country are periodically updated and distributed to all the parties involved where we have activity.

The EMA, in their updated guideline, version 4 of February 4th 2021, includes the possibility of carrying out the Source Data Verification remotely in the actual pandemic context, as long as compliance with national and European regulation is ensured (included the one implemented as response to the pandemic emergency).

The different national CAs have taken the European directive related to remote monitoring activities, Source Data Verification and conditions for that, authorising them as long as methods can be used to restrict access to trial participant records, according to the principles of necessity and proportionality and with the Data Protection Agency. We are continuously in contact with the agencies to solve our doubts related to remote monitoring.

The EMA emphasizes the need to carry out a risk assessment and implement risk-based monitoring whenever possible, with preference for centralized and remote monitoring if the risk / benefit balance allows it.

It is recommended that the sponsor updates the trial monitoring plans periodically during the pandemic, adapting the exceptional measures to the epidemiological situation.

The future of monitoring is “remote monitoring” and both sites and we as CRO must be prepared for it, adapting to digitization with technological solutions, and taking it to standardized procedures.

A digital abilities assessment will be carried out for the development of the technology systems and their improvement.

Continue to promote home working in monitoring activities as much as possible to change the current monitoring model towards a model of remote assistance to sites and investigators.

The PMs will continue informing all the clients involved about the measures to be followed in the management of clinical trials after this special situation occurred. We will continue to

confirm with client if these measures are already being addressed at the CRO/Sponsor level and if we can collaborate with our contribution by offering each required activity that is contemplated in the UE and local guides, such as the report of exceptional measures adopted, conducting the risk assessment and justification, the contingency plan and timely regulatory notifications.

León Research will keep its activity through home working all the time needed for the benefit of workers’ health and business continuity. Nevertheless, all those employees who wish to do so may go to work at the respective offices already open (where all security measures needed have been implemented).

Monitoring visits are being carried out in the different sites, always following the security measures and the specific guidelines provided by each site. During the period December 2020 – February 2021, there have been occasional cancellations according to the evolution of the management of the third wave in the different hospitals.

Following the protocols to resume work activities in the safest way and agreed by the company and workers:

  • All workers have been informed of preventive measures for personnel in their own work centres, and for the movement of personnel to other centres due to their activity. Document prepared by the Occupational Risk Prevention service (Spain).
  • It is considered not necessary to provide more personal protective equipment for workers since it is a mandatory measure as citizens and not as a work team at this time.
  • Follow the updates on the measures of each site to visit.

We keep full-time work activity for those who need it with collaborations in other departments, such as quality, HR, business development, and carrying out training activities mainly online.

Financial measures

We have applied the Paid Licence in which the hours not worked during the alarm and home working period are accumulated to be recovered before the end of the year. A document annexed to the workers’ agreement has been provided to establish this commitment.

Finally, there has been an effective payment of the extra payment corresponding to the first semester after the balance of the financial conditions of the same with positive results.

We have suspended extra payments until financial conditions allow the payment, until further analysis of the financial balance for the second half of the year.

During this period of health crisis, with the home working measure and the closed headquarters (León, Madrid, Torino and Rome) it was possible to reduce the structural costs in addition to achieving a lower risk of contagion. This measure has been reduced with the opening of the different headquarters and enumeration of 2021.

For the next year, we intend to lower the percentage of expenses and billing on trips, given that remote monitoring, implementation of Risk Based Monitoring and centralized monitoring are intended.

Communication measures

We are using creative methods to feel connected, stay involved and contribute to building an online culture, with meetings or virtual coffees, web-based communications of the measures and activities taken, as well as marketing actions aimed at generating an optimistic spirit to overcome the situation.

We keep working closely with our clients to ensure that the business continuity plan (BCP) is strong enough to face the future. This type of planning requires a high level of transparency from each party involved, allowing us to anticipate and anticipate possible challenges.

Proactively design new ways to collaborate with our clients.

The spirit is to maintain close contact with all employees, customers and suppliers.

Our commitment and effort are essential to continue offering our services with the least possible impact, transmitting and adopting the necessary preventive measures and the measures adopted for the continuity of activities for ongoing clinical studies or new proposals.

Fortunately, all employees are safe and healthy, and all of them continue to work with the same or even more dedication.

During the activity via home working, keep in mind that the impact on our operating capacity is limited to the production capacity of our service and minimally to the support activity of the production.

The activity of each department and the set of the company is carried out with relative normality.

We will continue to work to define critical services and determine necessary actions to ensure continuity. The different areas remain fully operational and provide services with relative normality.

We will implement new services more appropriate to the productive possibilities that we have due to the current situation but that can help the development of the organization’s activity once the health emergency situation has ended.

General Measures July 10th, 2020

Operational measures

We will follow the guidelines issued by the Competent Regulatory Authorities for the management of clinical trials during COVID-19. These guides from both the EMA and CA of each country are periodically updated and distributed to all the parties involved where we have activity.

National Competent Authorities have begun to search for time options related to remote monitoring, source data verification,and conditions therefor, provided that methods that restrict access to the records of trial trial participants can be used, in line with the principles of necessity and proportionality, in accordance with the Data Protection AgenciesWe are in continuous contact with the agencies to resolve doubts and questions raised for remote monitoring.

The AEMPS is working together with the AEPD on the necessary standards so that remote monitoring with verification of source data can be viable once the pandemic has been overcome.

The future of monitoring is “remote monitoring” and both sites and we as CRO must be prepared for it, adapting to digitization with technological solutions, and taking it to standardized procedures.

Continue to promote teleworking in monitoring activities as much as possible to change the current monitoring model towards a model of remote assistance to sites and investigators.

León Research considers maintaining activity through teleworking for longer, regardless of the evolution of the different phases of each localit/ Country, for the benefit of worker health and business continuity.

The return to the respective offices will be based on the global evolution of the situation generated by the health crisis, the circumstances of the company, and will always be carried out progressively by the workers.

Given the progress of the current situation, monitoring visits are being carried out in the different centers, always following the security measures and the specific guidelines provided by each site.

Following the protocols to resume work activities in the safest way and agreed by the company and workers:

  • The identification and evaluation of personnel especially sensitive to SARS-COV-2 is completed to define if additional measures are necessary to adapt the job position. No further action is required after evaluation.
  • All workers have been informed of preventive measures for personnel in their own work centers, and for the movement of personnel to other centers due to their activity. Document prepared by the Occupational Risk Prevention service according to the government’s recommendations and that agreed by the company.
  • Provide individual protection equipment for workers, who will receive them before displacement, and when they go to the workplace itself. The monitors have received the protective equipment for their activities.
  • Follow the updates on the measures of each site to visit.
  • León Research’s travel policy prevails on the use of public transport instead of using a private car, however, the worker is offered the possibility of traveling by private transport, in accordance with government recommendations, but must do so assuming the cost difference. In other words, the company will only pay for travel expenses the amount that would correspond if the trip were by public transport, having to assume the extra cost the worker (In the event that there is no possibility of taking a trip on public transport, the company’s travel policy regarding its management is maintained)

Continue promoting the search for options or ways to complete the work activity full time during the telework period, such as collaborations with other departments, for the operation of training plans, HR, quality, and online training.

Financial measures

We have applied the Paid Licence or Hours Pool system in which the hours not worked during the alarm and teleworking period are accumulated to be recovered before the end of the year. A document annexed to the workers’ agreetment will be provided to establish this commitment.

We have suspended extra payments until financial conditions allow the payment, until further analysis of the financial balance for the first half of the year.

In order to reduce structural costs as much as possible, we have decided to maintain the teleworking policy until a relatively normal situation can be met, and all our offices (León, Madrid, Turin and Rome) will remain closed until the risk contagion is reduced.

Communication measures

We are using creative methods to feel connected, stay involved and contribute to building an online culture, with meetings or virtual coffees, web-based communications of the measures and activities taken, as well as marketing actions aimed at generating an optimistic spirit to overcome the situation.

We continue to collaborate closely with our clients to ensure that the business continuity plan (BCP) has the necessary strength to face the future. We are very grateful that they have shared their concerns and plans with us, and for communicating to us what their current needs are. Crises demand and generate innovation (eg, process redesign, system automation, team cohesion, and more). Our goal is not only to get out of this situation safely, but to make it stronger.

This type of planning requires a high level of transparency from each party involved, allowing us to anticipate and anticipate possible challenges.

Proactively design new ways to collaborate with our clients.

Since the beginning of this pandemic, a close contact has been maintained with all employees, customers and suppliers.

Our commitment and effort is essential to continue offering our services with the least possible impact, transmitting and adopting the necessary preventive measures and the measures adopted for the continuity of activities for ongoing clinical studies or new proposals.

Fortunately, all employees are safe and healthy, and all of them continue to work with the same dedication.

During the teleworking activity, no impact was observed on our operational capacity.

We will continue working to define critical services and determine the necessary actions to guarantee their continuity. The different areas are still fully operational and provide services with complete normality.

General Measures June 1st, 2020

Operational measures

We will follow the guidelines issued by the Competent Regulatory Authorities for the management of clinical trials during COVID-19. These guides from both the EMA and CA of each country are periodically updated and distributed to all the parties involved where we have activity.

National Competent Authorities have begun to search for time options related to remote monitoring, remote access to medical records, and conditions therefor, provided that methods that restrict access to the records of trial trial participants can be used, in line with the principles of necessity and proportionality.

We are in continuous contact with the agencies to resolve doubts and questions raised for remote monitoring.

León Research will maintain the activity through teleworking during the period considered, regardless of the evolution of the different phases of each locality/Country, for the benefit of the health of the workers and the continuity of the business.

The return to the respective offices will be based on the global evolution of the situation generated by the pandemic, the circumstances of the company, and will always be carried out progressively by the workers.

Continue to promote teleworking in monitoring activities as much as possible to change the current monitoring model towards a remote assistance model for sites and investigators.

Given the progress of the current situation, the monitoring visits are resumed in the differents sites, always following the security measures and the specific guidelines provided from each site.

New protocols to resume work activities in the safest way and agreed by the company and workers:

  • By identifying and evaluating personnel especially sensitive to SARS-COV-2 to define whether additional measures are necessary to adapt the job position.
  • Document with the preventive measures for the personnel in the own work centers, and for the displacement of personnel to other center due to their activity. Document prepared by the Occupational Risk Prevention service according to the government’s recommendations and that agreed by the company.
  • Provide individual protection equipment for workers, who will receive them before displacement, and when they go to the workplace itself.
  • Know the preventive measures of each site to visit.
  • Provide a safe-conduct for the justification of business trips between provinces/localities.
  • León Research’s travel policy prevails on the use of public transport instead of using a private car, however, the worker is offered the possibility of traveling by private transport, in accordance with government recommendations, but must do so assuming the cost difference. In other words, the company will only pay for travel expenses the amount that would correspond if the trip were by public transport, having to assume the extra cost the worker (In the event that there is no possibility of taking a trip on public transport, the company’s travel policy regarding its management is maintained)

Continue promoting the search for options or ways to complete the work activity full time during the telework period, such as collaborations with other departments, for the operation of training plans, HR, quality, and online training.

Financial measures

We have applied the Paid Licence or Hours Pool system in which the hours not worked during the alarm and teleworking period are accumulated to be recovered before the end of the year.

A document annexed to the workers’ agreetment will be provided to establish this commitment.

The suspension of the bono extra payments until the financial conditions allow the payment.

In order to reduce structural costs as much as possible, we have decided to maintain the teleworking policy until a relatively normal situation can be met, and all our offices (León, Madrid, Turin and Rome) will remain closed until the risk contagion is reduced.

Communication measures

We are using creative methods to feel connected, stay involved and contribute to building an online culture, with meetings or virtual coffees, web-based communications of the measures and activities taken, as well as marketing actions aimed at generating an optimistic spirit to overcome the situation.

We continue to collaborate closely with our clients to ensure that the business continuity plan (BCP) has the necessary strength to face the future. We are very grateful that they have shared their concerns and plans with us, and for communicating to us what their current needs are. Crises demand and generate innovation (eg, process redesign, system automation, team cohesion, and more). Our goal is not only to get out of this situation safely, but to make it stronger.

This type of planning requires a high level of transparency from each party involved, allowing us to anticipate and anticipate possible challenges.

Proactively design new ways to collaborate with our clients.

Since the beginning of this pandemic, a close contact has been maintained with all employees, customers and suppliers.

Our commitment and effort is essential to continue offering our services with the least possible impact, transmitting and adopting the necessary preventive measures and the measures adopted for the continuity of activities for ongoing clinical studies or new proposals.

Fortunately, all employees are safe and healthy, and all of them continue to work with the same dedication.

During the teleworking activity, no impact was observed on our operational capacity.

We will continue working to define critical services and determine the necessary actions to guarantee their continuity. The different areas are still fully operational and provide services with complete normality.

General Measures May 4th, 2020

After the last financial analysis carried out by the Direction where the income and expenses of the first quarter are analyzed, the Direction comunicated the measures adopted by e-mail on April 15 related to the continuity of the organization and avoid resorting to the application of Temporary Employment Regulation Process (ERTE) or any other measure aimed at reducing personnel, and among these measures are:

  • The application of application of the Paid Licence or Hours Pool system that will be described, so that the hours not worked during the alarm and teleworking period are accumulated to be worked before the end of the year; or
  • The suspension of the bono as summer extra payments until the financial conditions allow the payment. As previously indicated, a document annexed to the workers’ agreetment will be prepared to establish this commitment.
  • Lastly, the aim is to reduce structural costs as much as possible so that other costs that are considered more relevant, such as personnel costs, can be met, and it has been decided to maintain the teleworking policy until a relatively normal situation can be re-established, and all offices (León, Madrid, Turin and Rome) will remain closed until the risk of contagion is reduced

It is also specified that the search for options or ways to complete the work activity full time during the teleworking period should be encouraged, such as collaborations with other departments, on-line training … look for new ideas among all to change the monitoring model towards a model of remote assistance to sites and researchers, to work on the operation of training plans, HR, quality, etc.

The specific prevention measures against COVID-19 are being agreed in collaboration with the external Occupational Risk Prevention Service for all personnel in their own work centers, as well as for personnel who must travel to research site, or any other, due to their activity. They will be communicated in writing to each worker once it is approved for information and compliance by both the company and the workers.

In accordance with these prevention measures, various vendors will be contracted to offer the Individual Protection Equipment and services of diagnostic tests for workers.

León Research will maintain the activity through teleworking during the period considered, regardless of the state of alarm decrees of each Country, for the benefit of the health of the workers and the continuity of the business.

The return to the respective offices will be based on the global evolution of the situation generated by the pandemic, the circumstances of the company, and will always be progressively, taking into account when normal activity can be resumed as a CRO.

All employees continue their activity by teleworking and no impact on our operating capacity has been observed.

Our sector is recognized as an essential activity, so we continue with our activities, transmitting and adopting the appropriate preventive safety measures and the measures adopted for the continuity of activities for ongoing clinical studies or new proposals.

We have updated the Guidances to manage Clinical Trial during COVID-19 that includes the latest measures adopted for the management of clinical trials with the recommendation and guidelines of the European Medicines Agency (EMA), version 3 of 28 April 2020, as well as the latest published local recommendations from the competent authorities of each country as complementary measures to those of the EU.

The PMs will continue informing all the clients involved about the measures to follow in the management of clinical trials during this special situation. We take the opportunity to confirm if these measures are already being addressed at the CRO Sponsor level and if we can collaborate with our contribution by offering each required activity that is contemplated in the UE and local guides, such as conducting the risk assessment, the contingency plan and timely regulatory notifications.

Committed to adapting to the new situation, using creative methods to feel connected, stay involved and contribute to building an online culture that helps us all, with virtual meetings and web-based communications of the measures taken and activities, as well as marketing actions aimed at generating an optimistic spirit to overcome the situation.

As in the communication of the past few weeks, our global operations continue to provide service and that the impact on our capabilities and service levels has been minimal.

We will collaborate closely with our clients to ensure that the business continuity plan (BCP) has the necessary strength to face the future. This type of planning requires a high level of transparency from each involved part, which allows us to anticipate and anticipate possible challenges.

We have spoken to many of our clients about the Business Continuity Plan (BCP) and we are very grateful that they have shared their concerns and plans with us, and for communicating to us what their current needs are. This allows us to proactively design new ways to collaborate with our clients. Crises demand and generate innovation (eg, process redesign, system automation, team cohesion, and more). Our goal is not only to get out of this situation safely, but to make it stronger.

Since the beginning of this pandemic we have maintained close contact with all employees, customers and suppliers. Our commitment and effort is essential to continue offering our services with the least possible impact. Fortunately, all employees are safe an d healthy, all of them continue to work with the same dedication.

General Measures April 15 th, 2020

We are following the latest measures adopted for the management of clinical trials with the recommendation and guidelines of the European Medicines Agency (EMA), as well as the latest published local recommendations from the competent authorities of each country as complementary measures to those of the EU.

PMs have informed all the clients involved about the measures to follow in the management of clinical trials during this special situation. We take the opportunity to confirm if these measures are already being addressed at the CRO Sponsor level and if we can collaborate with our contribution by offering each required activity that is contemplated in the UE and local guides, such as conducting the risk assessment, the contingency plan and timely regulatory notifications.

Nevertheless, since the coronavirus emergency situation and containment measures are likely to last for a prolonged period, several NCAs have started to look into temporary options related to remote access and conditions for such, providing that methods can be used that restricts access to participants’ trial records, in line with the principles of necessity and proportionality. This should however also be clarified with other relevant authorities in this area (such as, without limitation, Ethics Committees and data protection agencies) and is consequently not allowed unless a member state has given specific guidance allowing this.
Until now, no Competent Authority has issued a specific guide, and consultations must be carried out with the DPOs of the sites and the Data Protection Agencies of each country, to define the procedures to be followed as CRO in monitoring activities.

All our facilities are closed, even so our sector is recognized as an essential activity, for this reason we continue with our activities, transmitting and adopting the appropriate preventive safety measures and the measures adopted for the continuity of activities for ongoing clinical studies. or new proposals.

All employees continue their activity by teleworking and no impact on our operating capacity has been observed.

León Research management board encourages compliance with these measures and home confinement for the good and safety of all, except in situations allowed by the authorities of each country.

Committed to adapting to the new situation, using creative methods to feel connected, stay involved and contribute to building an online culture that helps us all, with virtual meetings and web-based communications of the measures taken and activities.

In view of the occurrence of a change in the alarm situation of each country in the next weeks, Leon Research will encourage continuing with the activity by teleworking, and the return to the respective offices will be progressive, as well as normal activity will be adapted little by little depending on each circumstance.

As in the communication of the past few weeks, our global operations continue to provide service and that the impact on our capabilities and service levels has been minimal.

We will collaborate closely with our clients to ensure that the business continuity plan (BCP) has the necessary strength to face the future. This type of planning requires a high level of transparency from each involved part, which allows us to anticipate and anticipate possible challenges.

General Measures April 3rd, 2020

We are following the latest measures adopted for the management of clinical trials with the recommendations and guides of the European Medicines Agency (EMA), version 2 dated on March 27, 2020, and some local recommendations of the competent authorities. Please click below to read them.

All our offices are closed by order of local governments, but even so, our sector as a recognized essential activity, we continue with our necessary activities, transmitting and adopting the appropriate preventive measures.

All employees continue their activity by teleworking and no impact on our operating capacity has been observed.

León Research management board encourages compliance with these measures and home confinement for the good and safety of all, except in situations allowed by the authorities of each country.

We are committed to adapting to the new situation, using creative methods to feel connected, stay involved and contribute to building an online culture that helps us all, with virtual meetings and web-based communications of the measures taken and activities.

In view of the occurrence of a change in the alarm situation of each country in the next few days, Leon Research will encourage continuing with the activity by teleworking, and the return to the respective offices will be progressive, as well as normal activity will be adapted little by little depending on each circumstance.

As in the communication of the past few weeks, our global operations continue to provide service and that the impact on our capabilities and service levels has been minimal.

We will collaborate closely with our clients to ensure that the business continuity plan (BCP) has the necessary strength to face the future. This type of planning requires a high level of transparency from each involved part, which allows us to anticipate and anticipate possible challenges.

All employees will have a few days of vacation during the Easter period from April 6 to 13, paying the correct attention to the mobile phone in case of any urgent need.

General measures March 25th, 2020

Proper communication will be maintained with both suppliers and clients about updates to these measures.

We suspend of all face-to-face training activities, both internal and external.

All possible activity will be maintained through teleworking, guaranteeing communication channels and the fluidity of it (this implies special attention to professional mobile line during the period of continuous teleworking).

In the case of the activities related to the visits necessary for the management of the studies, the instructions of the international, European and local regulatory agencies will be followed for the management of clinical trials, which include remote monitoring and avoiding the performance of any on-site monitoring visit until becomes possible again, and always informing trial sponsors.

All monitors must communicate the modification of any visit by the sites to the Sponsors. Confirmation of cancellation will always be requested in writing and this must be sent to the country’s COM to carry out the appropriate follow-up (for the purposes of possible cancellation costs and subsequent billing follow-up). All monitors will consult with sites and Sponsors about the possibility of carrying out remote monitoring to compensate for the cancellations suffered.

At the date of this measure, the trips to, or that passes through places declared as a focus and high risk will be avoided as far as possible, following the recommendation of the government of each country,

Any worker who is exposed to contagion, either by visiting a hospital, or a work trip, must notify it and keep the quarantine period of up to 17 days before having contact with third parties. This situation must also be reported in the event that exposure to contagion occurs outside of work functions.

In the event that any employee of the operational departments gets the disease, there will be a back-up previously formed in the study to be able to continue the activity. In the case of not having a backup, a substitute will be determined by Leon Research and this decision communicated to the sponsor. In the event that any employee with functions in internal departments gets the disease, it will be determined by Leon Research, and may decide to distribute the tasks among members of Leon Research to assume those functions.

Since the activity will be reduced in the coming weeks, it has been considered to apply teleworking as much as possible and in a second step the application of the Paid Licence or Hours Pool system to adapt to productive needs when possible.

Regarding the Easter Holidays period that was already indicated as the vacation period assigned by the company, it remains as such for all employees regardless of whether the employees have requested the enjoyment or exchange thereof.

SPECIFIC MEASURES FOR SPAIN

February 23rd, 2021

The state of alarm for COVID-19 is extended from 00:00 on November 9, 2020 until 00:00 on May 9, 2021 throughout the territory. In this Royal Decree, the freedom of movement of people at night is limited, as long as the corresponding delegated competent authority does not determine its modulation, flexibility or suspension. Each Autonomous Community will determine the time of the curfew.

Royal Decree-Law 21/2020, of June 9, on urgent prevention, containment and coordination measures to face the health crisis caused by COVID-19, establishes, among others, the following prevention and hygiene measures in work centers:

  • Obligation to use a mask in the workplace, in common places (offices, bathrooms, dining room, etc.), such as entrances, meetings, travel of any kind through the centre in which case, in addition to the use of the mask, it is It is necessary to keep the distance of 1.5 m.
  • Adopt ventilation, cleaning and disinfection measures appropriate to the characteristics and intensity of use of the work places, in accordance with the protocols established in each case.
  • Make soap and water, or hydroalcoholic gels or disinfectants with virucidal activity available to workers, authorized and registered by the Ministry of Health for hand cleaning.
  • Adapt working conditions, including the arrangement of jobs and the organization of shifts, as well as the use of common places in such a way as to guarantee the maintenance of a minimum interpersonal safety distance of 1.5 meters among workers.
  • Adopt measures to avoid the massive coincidence of people, both workers and clients or users, in the work centres during the hours of foreseeable greater influx.
  • Adopt measures for the progressive reincorporation in person to the jobs and the promotion of the use of home working when it is possible due to the nature of the work activity. When this is not possible, workers must be provided with protective equipment appropriate to the level of risk.

Workers with symptoms at their jobs

People who have symptoms compatible with COVID-19 or are in home isolation due to a diagnosis of COVID-19, or who are in a home quarantine period due to having had close contact with someone with COVID-19, will not have to go to their workplace.

The quarantine period will be determined by medical professionals who assess the severity or mildness of the symptoms.

Follow the document provided by the Occupational Risk Prevention Service

Displacement of workers to other communities with perimeter restrictions

A travel authorization will be provided by the company to justify said work displacements in compliance with the work activity, considered essential. 

If a worker begins to have symptoms compatible with the disease, he or she will immediately contact the telephone number set up for this purpose by the autonomous community (or Emergencies 112) or at the corresponding health centres, and, if necessary, with the risk prevention company.

Immediately, the worker will put on a mask and follow the recommendations indicated, until his medical situation is assessed by a health professional.

  • Consult the general hygiene and prevention measures adopted by each Autonomous Community, as well as the restrictions

Related to investigational studies management

Document: Guidances to manage clinical trial-COVID-19_No.7_3Mar2021 contains the latest information on the specific measures for the management of clinical trials in Spain, issued by the Spanish Agency for Medicines and Health Products (AEMPS) through the update of the Instruction Document of the Spanish Agency for Medicines and Health Products for conducting clinical trials in Spain (RD 1090/2015). Version 13, of November 30, 2020.

It is specifically updated:

  • Update on the exceptional measures applicable to clinical trials to manage the problems derived from the COVID-19 emergency, related to remote monitoring.
  • Clinical trials aimed at researching new drugs against coronavirus. Each Sponsor/ client will be informed of the need to update the report on exceptional measures after June 21 sending the quarterly report using annexx XII of AEMPS, with the data of each ongoing study and if remote monitoring has been carried out with SDV.

The measures applied will be communicated to all the parties involved, as well as to the sponsors who request it, and taking into account all subsequent updates if the case arises.

July 10th, 2020

The Royal Decree 463/2020 of March 14 declared the state of alarm throughout the national territory in order to face the health crisis caused by COVID-19, which has been extended on six occasions, the last through Royal Decree 555/2020, of June 5, until 00:00 on June 21, 2020.

More than three months after the state of alarm was declared, on June 21 the state of alarm concluded throughout the territory, and the new normality has arrived with the aim of restricting movements throughout the national territory.

On June 25, Royal Decree-Law 21/2020, of June 9, was published on urgent measures of prevention, containment and coordination to face the health crisis caused by COVID-19. Its validity will last until the Government declares that the health crisis has ended, and according to the Government it will occur when there is an effective therapy or vaccine against the virus.

The Royal Decree Law of the ‘new normality’ lays the foundations for hygiene and safety measures that must be respected throughout the Spanish territory, where each CCAA establishes its own rules for each activity:

  • Emphasis is placed on social distancing, distance now fixed at 1.5 m.
  • The mandatory use of masks for those over 6 years of age when these distances cannot be maintained, on public roads, in open air spaces and in closed spaces for public use, including transport or that are open to the public. Possible fines of up to 100 euros.
  • The tracking of contacts of possible cases is reinforced.
  •  COVID-19 is considered as “an urgent notifiable disease”.
  • The health services of the autonomous communities will guarantee that, especially in primary health care, any suspected case of COVID-19 will undergo a diagnostic test by PCR (Polymerase Chain Reaction) or another technique molecular diagnosis, as soon as possible from the knowledge of the symptoms, and that all derived information is transmitted in a timely manner as established by the competent health authority.
  • Prioritize teleworking whenever possible and adopt measures for the progressive reincorporation in person to jobs, with job management.
  • People who have symptoms compatible with COVID-19 or are in home isolation due to a diagnosis by COVID-19 or who are in a period of home quarantine due to having close contact with someone with COVID-19 should not go to their workplace.
  • If a worker begins to have symptoms compatible with the disease, the telephone number enabled by the autonomous community or corresponding health center will be immediately contacted, and, where appropriate, with the corresponding occupational risk prevention services. Immediately, the worker will put on a mask and will follow the recommendations indicated, until her medical situation is evaluated by a health professional.
  • Reducing the quarantine from 14 to 10 days for people infected with Covid-19 coronavirus is not an individual decision, but a series of conditions have to be met and it will be the medical professionals who evaluate the severity or mildness of the symptoms.

A new decalogue is provided on how to act in case of symptoms, published by the Ministry of Health on June 22, 2020, and on the correct use of masks.

Consult the general hygiene and prevention measures adopted by each Autonomous Community.

As of July 1, intra-community travel and no quarantine period of 14 days after arrival are allowed.

Related to investigational studies management

The document “Guidance to manage clinical trials No.6” gathers the information contained in the guidelines with the specificy measures for clinical trials management in Spain, issued by Spanish Agency of Drugs and Medical Devices (AEMPS), through the updating of the Instruction Document of the Spanish Agency for Medicines and Health Products for conducting clinical trials in Spain (RD 1090/2015) Version 12, of June 29, 2020.

Clarification is published on the application of the interruption of deadlines derived from the emergency by COVID-19 to clinical trial authorizations.

Annex XII of the instructions: Model of the Report on the exceptional measures adopted to manage the problems derived from the emergency by COVID-19 (Version June 29, 2020).

Each sponsor will be informed of the availability as a CRO to prepare and submit, to the Competent Authorities, the report with the data of each study in progress, since since June 21 they have 4 months to carry out this action.

The applied measures will be communicated to all the parties involved, as well as to the promoters who request it, and taking into account all subsequent updates if necessary.

June 1st, 2020

Royal Decree 537/2020, of May 22, extending the state of alarm declared by Royal Decree 463/2020, of March 14, declaring the state of alarm for the management of the health situation caused by COVID-19.

The duration of this alarm state is extended until 00:00 hours of June 7 of 2020, and with the expectation that there will be more extensions until the end of the de-escalation phases, depending on the evolution of the pandemic, and of infections that may occur throughout the country, and may be expanded by the government in the coming week.

“Plan for transition to a new normality” in which the de-escalation plan is explained, including an annex detailing the characteristics of the lifting of limitations for each sector and field of activity are described.

Operation of the de-escalation plan, for the resumption of work activity:

  • The measures adopted will depend on the phase status of each territory.
  • This plan has 4 phases. Each phase lasts two weeks. These dates are not fixed and may change if, for example, the number of people infected with coronavirus increases.
  • The phase changes are published by the Ministry of Health, depending on the criteria and indicators for the change to the next phase.
  • An important measure is that people cannot leave their provinces until phase III, but they can move to other provinces for work reasons.

The entire national territory is between phase I to phase III, specifically the province of León and Madrid are in Phase I.

Consult the general measures adopted and the activities allowed in each phase for the different provinces.

As of July 1, it is anticipated that intra-community travel will be permitted without a quarantine period of 14 days after arrival.

Related to investigational studies management

The documentGuidances to manage clinical trial-COVID-19_No.5_01June2020″ gathers the information contained in the guidelines with the specificy measures for clinical trials management in Spain, issued by Spanish Agency of Drugs and Medical Devices (AEMPS), on 4 May 2020.

Actions of the AEMPS to speed up and promote clinical trials and observational studies on COVID-19” Date of publication: 4 May 2020.

 The applied measures will be communicated to all the parties involved, as well as to the promoters who request it, and taking into account all subsequent updates if necessary.

At the time of this update any review of the AEMPS issued measures has been made.

The latest Q&A document from the AEMPS meeting with AECIC is provided to the operations team.

The AEMPS will conduct remote Good Pharmacovigilance Practice inspections due to the COVID-19 Document published on 28 May 2020.

May 4th ,2020

Essential and non-essential activities restart on April 13th of 2020 based on alarm state decreed in RD 462/2020 of March 14th, for the management of the health situation caused by COVID-19.

The duration of this alarm state will be extended, through a new RD published on April 25th, until 00:00 hours of May 10th of 2020 based on the pandemics development and on the possible infections that may happen in this country, it could be extended again by the Government the next weeks (15 more days). All measures implemented in the decree and mentioned in the last update of this annex of March 16th, are still in force.

The Spanish Government has published the document “Plan para la transición hacia una nueva normalidad” (Plan for transition to a new normal)” in which it is explained the de-escalation plan, including an annex in which characteristics for the restrictions lifting for each sector and part of activity are described.

The fundamental aim of the de-escalation plan is to achieve a gradual recovery of economic activity and daily lives, minimizing the risk coronavirus COVID-19 epidemics represents for public health. The back to normality will require maintaining for more time the socioeconomic mitigation measures in order to recover productive activities and employment of the most affected sectors.

In the published text, it is indicated that if the available data on the evolution of the disease conclude at the end of the period of validity of this third extension that the containment measures allow the objectives set for this new phase to be reached, “a scenario of gradual lifting of the extended measures ”

The de-escalation of the lockdown will have 4 phases beginning on May 4th and will last at least eight weeks, until the end of June. Each phase will last 2 weeks and we will move to the next phase if health indicators show that it is possible to go on.

All the measures will be enforced by provinces or islands and their enforcement will end at the ending of June, when, if everything goes ok, it will be considered that the “new normality” has been reached, if the epidemics have been controlled in all territories.

Transition will be gradual asymmetrical, coordinated with the autonomous communities and adaptative, the different phases will not last the same period in the whole country, avoiding the possible collapse of the National Health System.

Movements between provinces will not be allowed until the end of June, with the exceptions considered in the decree. The control measures and the preventive materil use will continue in this normality stage.

Details of the phases and activities allowed are stablished in the Annex II of the Plan made by Spanish Government.

Particular dates and real evolution will depend on the pandemic’s behaviour and control, as well as the capacity for accomplishing the different phases with the conditions established in the Plan

  • Phase 0 begins on May 4th, it is the preparation for the transition, in all provinces with the exception of some islands that begin at phase 1.

Phase 1 will begin on May 11th in the provinces that fulfil the requirements.

Common regime applied to all activities:

  • Any allowed activity will be developed with security measures, self-protection and social distancing. Face masks use outside home is convenient and highly recommended when social distancing can´t be granted. Also, availability and access to hydroalcoholic solutions should be facilitated in order to practice frequent hand hygiene.
  •  All locals and other places, as well as their equipment, related to allowed activities must be periodically disinfected and sanitized.
  • In a general way, until new normality has ben reached after accomplishing phase III, travelling to other provinces different from the one in which the person lives will not be allowed, except for justified causes. Once in the new normality stage, travelling between provinces will be allowed if both of them have passed the phase III.
  • Any activity and its limitations, shown on the document annexed table (annex II; Guiding forecast for the lifting of the national limitations established in the state of alarm, depending on the phases of transition to a new normality), will be still in force in the following phases of the de-escalation, unless new different limitations are told.
  • Travels made, whichever the vehicle it is, must be for the realization of the allowed activities.

Summary of the “Plan for the transition to a new normality”, published on April 28th by the Health Ministry:

Phase 0, preparation for the de-escalation

This is today´s situation, characterized by the stablishing of common relieve measures for all the country once the infection curve has ben flattened, allowing mobility outside the house, mainly for private issues, with measures that reduce the infection risk to the minimum, only when safety indications are fulfilled, based on the citizen´s responsibility and self-protection (contactless individual sport activities and walks, care of family gardens, some economic activities with capacity control, etc.).

During this phase measures that would affect only to particular territories could be adopted.

Particularly, isolated and low infection risk islands.

Phase I or initial

Depending on the fulfilling of the different territories of the indications shown on the Indications Panel it will be allowed the partial opening of some activities, particularly, economic activities such as minor commerce opening with  previous appointment or counter service, restaurants and coffee shops with takeaway delivery, agricultural activities, professional sport activities, touristic accommodations with restrictions and common grounds not allowed, among other activities.

Phase II or intermediate

In this phase it would be possible to partially reopen activities limited in phase I, with place limitations, such as restaurants with table and terrace service, common places of touristic accommodations, big department stores, etc.

Phase III or advanced

In this phase, opening of all activities is foreeen, but always keeping appropriate safety and distance measures.

Among the measures to be considered in this phase, reopening of minor commerce that hadn´t previously opened, with limited capacity, pubs and discos with very limited capacity, museums and cultural shows with limited capacity too, etc

New normality

Economic and social restrictions end, but epidemic surveillance does not, as well as the reinforced capacity of National Health System and citizen´s self-protection

Related to investigational studies management

  • In the document “Guidances to manage clinical trial-COVID-19_No.4_04May2020″ it is shown the last onformation provided by the guide with the specifical measures for clinical trials management in Spain, issued by Spanish Agency of Drugs and Medical Devices (AEMPS), on April 7th of 2020.

The applied measures will be communicated to all the parties involved, as well as to the promoters who request it, and taking into account all subsequent updates if necessary.

  • At the time of this update any review of the AEMPS issued measures has been made.
  • Work still goes on with the Spanish Data Protection Agency (AEPD) regarding inquiries made to specialized inspectors for the management of patient data in remote activities for trials management.
  • Based on the responses obtained by our Data Protection service (Atico34), if the data are anonymized, the data protection regulations would not be breached, since the anonymized data is not personal data. They have provided us with the GDPR-based data anonymization procedures guide, which will continue to be studied to define the procedures to be followed as a CRO.

April 15th ,2020

The essential and non-essential activities are resumed as of April 13, 2020, based on the state of alarm decreed in RD 462/2020 of March 14, for the management of the health situation caused by COVID-19.

Our activity is considered essential activity for the measures adopted within Pharma sector.

As of the date of this update, the duration of the alarm state and confinement is extended until 00:00 on April 26, 2020, depending on the evolution of the pandemic, and the contagions that may occur throughout the country, and may be extended by the government for more weeks.

The measures implemented in the decree mentioned in the last update to this annex of March 16, 2020 are maintained.

The document “Guidance to manage clinical trials- COVID-19_nº3_15April2020” contains the latest information contained in the guide with specific measures for the management of clinical trials in Spain, issued by the Spanish Agency for Medicines and Health Products (AEMPS) on April 7, 2020. The measures applied will be communicated to all the parties involved, as well as to the promoters who request it, and considering all subsequent updates if the case arises.

The Spanish Data Protection Agency (AEPD) has issued several reports regarding the treatment of data in the COVID-19 situation, but they have not been so specific for the management of trials, so it is expected to obtain a clear answer in the following consultations with specialized inspectors.

Based on the responses obtained by our Data Protection service (Atico34), if the data is anonymized, the data protection regulations would not be breached, since the anonymized data is not personal data. It has provided us with the GDPR-based data anonymization procedures guide, which will be studied, and we will continue working on defining the procedures to be followed as a CRO.

We are still waiting for a response to the query made to EC / CA about the suitability and possibility of obtaining scanned and anonymized Source Documents to be able to perform SDV remotely.

April 03rd ,2020

On March 28, 2020, the government notified of the state of total confinement until April 09, 2020, based on the state of alarm decreed in RD 462/2020 of March 14, for the management of the health crisis situation caused by COVID-19.

Our activity is considered essential activity for the measures adopted within Pharma sector.

As of the date of this update, the duration of the alarm status is maintained until April 12, 2020, depending on the evolution of the pandemic, and the contagions that may occur throughout the country, and may be extended for more weeks.

The document “Guidances to manage clinical trial-COVID-19_No.2_03Apr2020” gathers the information contained in the guidelines with specific measures for the management of clinical trials in Spain, issued by the Spanish Agency for Medicines and Medical Devices (AEMPS) on March 16th, 2020. The local applied measures will be communicated to all the parties involved, as well as to the sponsors who request it, and taking into account all subsequent updates if the case arises.

No update to the guidelines issued by the Spanish Agency for Medicines and Medical Devices (AEMPS) on March 16th, 2020 with specific measures for the management of clinical trials in Spain until till date.
We are waiting for a response from the Spanish Agency for Data Protection (AEPD) regarding the point of view of the monitoring of source documents versus GDPR.

We are waiting for a response to the query made to EC / CA about the suitability and possibility of obtaining scanned and anonymized Source Documents to be able to perform SDV remotely.

Previous update of March 25th, 2020

On March 22nd, 2020, the government notified an extension of the alert state, which was declared in Royal Decree 462/2020 of March 14th, for the management of the health crisis situation caused by COVID-19.

The duration of the alarm state is extended until April 11th, 2020 depending on the evolution of the pandemic, and the contagions that may occur throughout the country.

EC / CA have been questioned about the suitability and possibility of obtaining scanned and anonymized Source Documents to be able to perform SDV remotely.

EC / CA have been asked about the suitability and possibility of contracting an external provider that can carry out the clinical trial visits (including obtaining and processing samples). A potential vendor has been identified and will be contacted if approved.

At the date of this measure, all trips to, or that passes through places declared as a focus and high risk (Community of Madrid, Catalonia, the Basque Country and La Rioja) will be avoided in as much as possible following the recommendation of the Ministry of Health.

Previous update of March 16th, 2020

On March 13th, 2020, in the afternoon, the alert state in Spain was decreed by the government, pending to know the latest measures adopted by the authorities.

On March 14th, Royal Decree 463/2020 of March 14th was published, declaring the state of alert for the management of the health crisis situation caused by COVID-19. Entering into force at 00:00 on Sunday March 15th.

The declaration of alert status affects the entire national territory.

The duration of the state of alert that is declared by this royal decree is fifteen calendar days. Some of the measures implemented in the decree that could affect us in our activity:

  • Limitation of people’s freedom of movement.
  • During the state of alert, people may only circulate along the roads for public use for the following activities:

a) Acquisition of food, pharmaceutical products and essential necessities.

b) Assistance to health centres, services and establishments.

c) Travel to the workplace to carry out the professional activity.

d) Return to the place of habitual residence.

e) Assistance and care for the elderly, minors, dependents, people with disabilities or especially vulnerable people.

f)  Attending to financial and insurance entities.

g)  Due to force majeure or need.

h) Any other activity of a similar nature must be done individually, unless accompanied by people with disabilities or for other justified cause. The circulation of private vehicles is also allowed on public roads to carry out these permitted activities or to refuel.

  • Containment measures in the workplace, facilitating teleworking and suspension of face-to-face educational activity in all cycles while maintaining online activity.
  • Containment measures in the field of training, during the suspension period, educational activities will be maintained through distance and online modalities, whenever possible.
  • Containment measures in the field of commercial activity, cultural facilities, recreational establishments and activities, hotel and restaurant activities, and other additional activities. The opening of bars, catering establishments, discotheques, cultural and leisure facilities, sports venues, amusement parks, auditoriums is suspended, and open-air dances, parades and popular parties or folkloric demonstrations in open venues are prohibited.
  • Limitations on trade, all establishments will be closed except for pharmacies, kiosks, tobacconists, gas stations, orthopaedics, dry cleaners, opticians, medical centres, food markets, technology, and animal feed.
  • In this way, crowds will be avoided, and consumers and employees will be controlled to maintain the safety distance of at least one meter in order to avoid possible contagion.
  • Measures to ensure the supply of goods and services necessary for the protection of public health.
  • Transport measures. 50% reduction in the supply of trains, air transport and road transport and the frequency are limited. To guarantee distance, only one third of the maximum available places will be put up for sale.
  • Failure to comply with the state of alert is fined from 100 euros to 3 months in prison (for the crime of disobedience) or up to 4 years in prison (for attack towards the authority).

SPECIFIC MEASURES TO PORTUGAL

February 23rd, 2021

The state of alarm due to COVID-19 is extended from 00:00 on November 24 to 11:59 p.m. on March 1, 2021 throughout the national territory. The emergency situation at the national level will be evaluated every 15 days.

Traffic restrictions apply: movement between municipalities is prohibited on weekends, between 8:00 p.m. on Friday and 5:00 a.m. on Monday.

Border controls with Spain have been re-established.

Travel outside the continental territory:

  • Portuguese citizens are prohibited from traveling outside the continental territory, whether by land, rail, air, river or sea. Except for essential trips, among which the following stand out:
    • professional activities (duly documented);
    • departure from the continental territory of Portuguese citizens residing in other countries;
    • exceptionally, for the purposes of family reunification of spouses and relatives up to the 1st degree;
    • trips to the Autonomous Regions of the Azores and Madeira.

Transportation

  • Mandatory mask use
  • Public transport has a capacity limited to 2/3 of its capacity.
  • In taxis / TVDE, the front seats must be used only by the driver, and the passenger occupancy cannot exceed 2/3 of the remaining space.

Current measures for prevention and containment of COVID-19 are as follows:

  • Mandatory use of a mask in the workplace.
  • The possibility of carrying out body temperature measurements by non-invasive means when accessing workplaces, education centres, means of transport, commercial, cultural and sports spaces.
  • The possibility of requiring diagnostic tests for COVID-19, in access to health centres, residential structures, education centres, professional establishments when entering and leaving the national territory – by air or by sea – and other places, by determination of the DGS.
  • The possibility of asking for resources, tools and health centres both private and social, after trying to make an agreement and with a fair compensation.
  • The mobilization of human resources to strengthen the follow up capacity (for example: conducting epidemiological surveys, following up on contacts, following up on people under active surveillance).
  • Mandatory containment for COVID-19 patients and people under active surveillance
  • There will be a duty of home confinement, prohibiting circulation in public spaces and roads, with the exception of movements authorized by the authorities. in which they stand out:
    • Acquisition of goods and services;
    • Access to public services
    • Carrying out professional activities (as long as it comes accompanied by a statement)
    • Due to health issues;
    • Giving assistance to vulnerable people;
    • Attendance at schools;
    • Short term trips to perform physical activities, individually or with someone from your family group;
    • Pet walk;
    • Travel necessary to enter and exit the continent, including trips to and from the place of accommodation;
    • The return home within the scope of the permitted situations;
    • Refueling at service stations within the scope of permitted trips.

Stores and services open to the public:

  • Staples stores, supermarkets and hypermarkets may operate without schedule restrictions;
  • Health services, offices, dentists and pharmacies;
  • Restaurants and cafeterias may only work as take-out or home delivery restaurants;
  • Fairs and markets are allowed only for the sale of food.

In hotel bars and restaurants, operations are allowed for the purpose of making deliveries to guests’ rooms (room-service) or for the supply of meals or packaged products (take-away).

Home working

  • Home working is mandatory regardless of the employment relationship, provided that the functions in question allow it and the worker has the conditions to perform them, without the need for a written agreement between the employer and the worker, in the following situations:
  • The worker is covered by the exceptional protection regime for immunosuppressed and chronically ill patients who, according to the guidelines of the health authority, should be considered at risk, that is, hypertensive, diabetic, cardiovascular patients, people with chronic respiratory disease, patients with cancer and patients with kidney failure;
  • The disabled worker has a degree of disability equal to or greater than 60%;
  • The worker with a child or dependent under 12 years of age or with a disability or chronic disease that is considered at risk and cannot attend the teaching and training activities in the classroom.

General conditions:

  • Physical distancing
  • Frequent handwashing
  • Mandatory mask use
  • Respiratory label
  • App Stayaway COVID

Related to the management of research studies

The update of Document: Guidances to manage clinical trial-COVID-19_No.7_3Mar2021 includes the latest update with the specific measures for the management of clinical trials in Portugal, issued by the CEIC on March 31, 2020 including the review carried out on April 3, 2020. CEIC adopts in full EMA recommendations published in: Eudralex10: “Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic” – Version 3, reviewed April 28, 2020.

EUREC member CEIC has released the document “Position of the European Network of Research Ethics Committees (EUREC) on the Responsibility of Research Ethics Committees during the COVID-19 Pandemic” on May 15, 2020

Also included is the update of the document “COVID-19: Exceptional measures within the scope of Clinical Trials during the period of risk to public health (Version 3 dated 05/11/2020) published by INFARMED.

At the time of this update, no review has been made of the measures issued by INFARMED or CEIC.

July 10th, 2020

On March 18th, 2020, the government declared a state of alert throughout the national territory of Portugal.

The state of alert was declared finished on May 04th, 2020.

After the epidemiological situation of COVID-19, the calamity situation was declared in 19 the Lisbon Area until 23:59 July 14, 2020, without prejudice to the extension or modification as an evolution of the epidemiological situation or justification.

The land borders with Spain have been reopened on July 1, 2020.

By Resolution of the Council of Ministers No. 51-A/2020, of 26 june 2020, the follow-up of the gradual strategy to lift the containment measures against the pandemic of the disease COVID -19 is approved.

These measures are as follows:

Continental Portugal (status: alert). Measures:

  • Mandatory detention for sick people and under active supervision.
  • The rules of social distancing, use of masks, number of people in the spaces, hours of operation and sanitation are maintained.
  • Ban on events or meetings with more than 20 people.
  • Prohibition of alcohol consumption on public roads
  • Administrative offenses:
  • 100 a 500€ (singulars)
  • 1000 a 5000€ (companies)

Metropolitan Area Lisboa (status: contingency). Additional Measures:

  • Closing of commercial establishments at 8pm, with the exceptions:
  • Restaurants for meals and takeaways
  • Supermarkets and hypermarkets (until 10pm)
  • Fuel stations
  • Clinics and veterinarians
  • Pharmacies
  • Funeral homes
  • Ban on the sale of alcohol in service areas Gatherings limited to 10 people

Lisbon Parishes (status: calamity). Additional measures:

  • Civic duty of home collection
  • No street markets
  • Gatherings limited to 5 people
  • Strengthening of the surveillance of compulsory detention by civil protection, social security and community health teams – Healthy neighbourhoods program

General conditions:

Availability of masks and disinfectant gel for sale / Regular hygiene of spaces / Maximum reduced capacity / Hand hygiene and respiratory label / Physical distance (2m).

Related to investigational studies management

The document “Guidances to manage clinical trials No.6” gathers the information contained in the guidelines with specific measures for the management of clinical trials in Portugal, issued by CEIC on March 31st , 2020 including the review carried out on April 3, 2020. CEIC fully adopts the EMA recommendations published in: Eudralex10: Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic – Version 3, revised on April 28, 2020.

CEIC as a member of EUREC released the document “Position of the European Network of Research Ethics Committees (EUREC) on the Responsibility of Research Ethics Committees during the COVID-19 Pandemic” on May 15, 2020.

Also included is the update of the document “COVID-19: Exceptional measures within the scope of Clinical Trials during the period of risk to public health (Version 3 dated 11/05/2020) published by INFARMED.

At the time of this update any review of INFARMED issued measures has been made.

June 1st, 2020

On March 18th, 2020, the government declared a state of alert throughout the national territory of Portugal.

The state of alert was declared finished on May 04th, 2020.

After the epidemiological situation of COVID-19, the calamity situation was declared throughout the national territory until 11:59 pm on May 31, 2020, without prejudice to the extension or modification as an evolution of the epidemiological situation or justification

By Resolution of the Council of Ministers No. 33-C / 2020, of April 30, 2020, a gradual strategy is approved to lift the containment measures against the pandemic of the disease COVID -19 and the schedule of the strategy to survey containment measures with a 15-day period between each deflation phase to assess the impact of the measures on the evolution of the pandemic.

These measures are as follows:

General conditions:

  • Availability of masks and disinfectant gel for sale / Regular hygiene of spaces / Maximum reduced capacity / Hand hygiene and respiratory label / Physical distance (2m).

Planning:

Related to investigational studies management

The document Guidances to manage clinical trial-COVID-19_No.5_01June2020″ gathers the information contained in the guidelines with specific measures for the management of clinical trials in Portugal, issued by CEIC on March 31st , 2020 including the review carried out on April 3, 2020. CEIC fully adopts the EMA recommendations published in: Eudralex10: Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic – Version 3, revised on April 28, 2020.

CEIC as a member of EUREC released the document “Position of the European Network of Research Ethics Committees (EUREC) on the Responsibility of Research Ethics Committees during the COVID-19 Pandemic” on May 15, 2020.

Also included is the update of the document “COVID-19: Exceptional measures within the scope of Clinical Trials during the period of risk to public health (Version 3 dated 11/05/2020) published by INFARMED.

The local applied measures will be communicated to all parties involved, as well as to the sponsors who request so, and considering all subsequent updates if the case arises.

May 4th ,2020

On March 18th, 2020, the government declared a state of alert throughout the national territory of Portugal.

The state of alert will be declared finished on May 04th, 2020.

The government declares confinement from April 30 to May 04 in the areas of residence.

By Resolution of the Council of Ministers No. 33-C / 2020, of April 30, 2020, a gradual strategy is approved to lift the containment measures against the pandemic of the disease COVID -19 and the schedule of the strategy to survey containment measures with a 15-day period between each deflation phase to assess the impact of the measures on the evolution of the pandemic.

These measures are as follows:

  • General conditions: Availability of masks and disinfectant gel for sale / Regular hygiene of spaces / Maximum reduced capacity / Hand hygiene and respiratory label / Physical distance (2m).
  • Planning:

Related to investigational studies management

  • The document Guidances to manage clinical trial-COVID-19_No.4_04May2020″ that gathers the information contained in the guidelines with specific measures for the management of clinical trials in Portugal, issued by CEIC on March 31st , 2020 including the review carried out on April 3, 2020. CEIC fully adopts the EMA recommendations published in: Eudralex10: Guidance on the Management of Clinical Trials during the COVID-19 (Coronavirus) pandemic – Version 3, revised on April 28, 2020.
  • Also included is the update of the document “COVID-19: Exceptional measures within the scope of Clinical Trials during the period of risk to public health (Version 2 dated 15/04/2020) published by INFARMED.
  • The local applied measures will be communicated to all parties involved, as well as to the sponsors who request so, and considering all subsequent updates if the case arises.

April 15th ,2020

On March 18th, 2020, the government declared a state of alert throughout the national territory of Portugal.

The duration of the declared state of alert is extended to 17 April, 2020 and it will be extended possibly until 1 May, 2020.

The government has issued recommendations for the use of protective masks as preventive measures

The document “Guidance to manage clinical trials- COVID-19_nº3_15April2020” gathers the information contained in the guidelines with specific measures for the management of clinical trials in Portugal, issued by CEIC on March 31st , 2020 including the review carried out on April 3, 2020.
The local applied measures will be communicated to all parties involved, as well as to the sponsors who request so, and considering all subsequent updates if the case arises.

April 03rd ,2020

On March 18th, 2020, the government declared a state of alert throughout the national territory of Portugal.

The duration of the declared state of alert is extended to 17 April 2020.

The government declares confinement in the areas of residence from 9 April to 13 April, in addition as measures, declares social distancing, no more than 5 people and the airports will remain closed.

The document “Guidances to manage clinical trial-COVID-19_No.2_03Apr2020” gathers the information contained in the guidelines with specific measures for the management of clinical trials in Portugal, issued by CEIC on March 31st , 2020. The local applied measures will be communicated to all parties involved, as well as to the sponsors who request so, and taking into account all subsequent updates if the case arises.

Previous update of March 25th, 2020

On March 18th, 2020, the government declared a state of alert throughout the national territory of Portugal.

The duration of the declared state of alert is fifteen calendar days.

On March 22nd, Decree No. 2-A / 2020 of March 20th entered into force, regulating the application of the state of emergency decreed by the President of the Republic to manage the crisis situation health caused by COVID-19. It came into force at 00:00 hours on March 22nd. It has been rectified by Rectification Declaration No. 11-D / 2020 of March 22nd, 2020.

SPECIFIC MEASURES FOR ITALY

February 23rd, 2021

With the DECREE OF THE PRESIDENT OF THE COUNCIL OF MINISTERS of January 14, 2021, the Government indicates the restrictive measures against Covid-19 in force from January 17 to March 5, 2021 (General Series GU No. 11 of 15 -01-2021 – Ordinary Supplement n.2).

The Decree contains the measures applicable to the entire national territory and in regional areas differentiated by level of risk and replaces the Decree of the Prime Minister of December 3, 2020, later modified by the Natale DL and the Ponte DL.

The DPCM was anticipated by DL 2/2021 that dictated specific measures also on the vaccination plan, on complementary elections.

Among the latest measures: The Decree-Law of February 12, 2021, n. 12 extends the prohibition to travel between different regions or autonomous provinces until February 25, 2021 throughout the national territory, except for movements motivated by proven work needs or situations of need or for health reasons. As has already been foreseen, the return to one’s own residence, domicile or home is still allowed. The breakdown of the Autonomous Provinces in the yellow, orange and red zones is as follows, as of February 14, 2021:

  • yellow zone: Calabria, Campania, Basilicata, Emilia Romagna, Friuli Venezia Giulia, Lazio, Lombardia, Marche, Molise, Piemonte, Puglia, Sardegna, Valle de Aosta, Veneto
  • Orange zone: Abruzzo, Liguria, Toscana, Provincia Autonoma di Bolzano, Provincia Autonoma di Trento, Sicilia, Umbria.
  • Red zone: no regions

Activities allowed / not allowed in the yellow zone:

In this area it is possible to consume food and beverages within bars, restaurants and other catering activities, from 5:00 to 18:00. During the same hours the sale with take away food and drinks is allowed without restrictions. The sale with take away food is also possible from 6:00 p.m. to 10:00 p.m., but during these hours it is prohibited for subjects whose main activity is that of a bar without a kitchen (and other similar establishments – ATECO code 56.3) or retail trade of beverages. (ATECO code 47.25). Home delivery is allowed without a time limit, but in any case, it must be done in accordance with the regulations on packaging and delivery of products.

Public offices: In directive n. 2/2020 of the Ministry of Public Administrations, it should be noted that the activities of reception of the public or direct provision of services to the public, without prejudice to what is said in the same directive regarding non-postponable activities, are preferably guaranteed in a way electronic or in any case with such methods, the physical presence in the offices (for example, telephone appointment or virtual assistance) will be excluded or limited. In cases where the service cannot be provided in the aforementioned manner, access to the offices mentioned must be staggered, even by booking appointments, and frequent ventilation of the premises must be ensured.

Until February 25, 2021, in the yellow zone, it is allowed to travel between 5:00 a.m. and 10:00 p.m., within the Region or Autonomous Province itself, in compliance with the specific restrictions introduced to travel to other inhabited private homes (described in this same FAQ,

below). Displacements to other Regions or Autonomous Provinces are only allowed for proven work needs, situations of need or health reasons.

The return to one’s residence, domicile or home is always allowed. Regarding visits to friends or family, in this area it is allowed, once a day, to move to another inhabited private home in the same Community or Autonomous Province, between 5:00 and 22:00, for a maximum of two people, in addition to those already living together in the destination house. The person or two people who move can bring with them children under 14 years of age (or other children under 14 over whom the same people exercise parental authority) and disabled or non-self-sufficient people who live with them.

Respiratory protection devices (better known as masks) must be used both outdoors and indoors in places other than your home, except in cases where continuous isolation is guaranteed by each person who does not live together.

The obligation is not intended to:

  • people who, due to their disability or pathology, cannot wear the mask;
  • operators or people who, in order to assist a person, exempt from the obligation, cannot in turn wear a mask (for example: they have to speak at the L.I.S. with a deaf person).
  • In addition, the use of a mask is not mandatory, both outdoors and indoors:
  • while doing sports activities;
  • while eating or drinking, in the places and times when it is allowed;
  • when you are alone or exclusively with the people you live with.

Regarding the performance of work activities, the mask is mandatory in the situations provided for by the specific protocols of the sector.

However, the use of masks is strongly recommended even inside private homes, in the presence of people who do not live together.

The public or private employer is not obliged to provide all workers with the necessary tools to carry out their work in an agile manner. If the public administration or the private employer cannot provide the necessary equipment, the worker can still use his computerized means to carry out the work in an agile way. However, the Administration (or the private employer) is obliged to adopt organizational and management measures to facilitate the performance of the work in an agile way

Activities allowed / not allowed in the orange zone (affecting León Research’s work activity):

In this area, it is not allowed to consume food and beverages inside restaurants and other catering activities (including bars, pastry shops, ice cream parlors, etc.) and in their surroundings.

From 5:00 a.m. to 10:00 p.m. the sale with take-out food and drinks is allowed, as follows:

  • from 5 a.m. to 6 p.m., without restrictions;
  • from 6:00 p.m. to 10:00 p.m., subjects whose main activity is that of bars without kitchens (and other similar establishments – ATECO code 56.3) or the retail trade of beverages (ATECO code 47.25) is prohibited.

Home delivery is allowed without a time limit, but in any case it must be done in accordance with the regulations on packaging and delivery of products.

It is also allowed, without a time limit, the consumption of food and beverages within hotels and other accommodation activities, only for customers staying in them.

Public office activities: these are basically guaranteed electronically or in any case with methods that exclude or limit physical presence in the offices (for example, telephone appointment or virtual assistance).

From January 16 to March 5, 2021, in the orange zone, it is allowed to move within its Municipality, between 5:00 a.m. and 10:00 p.m., in compliance with the specific restrictions introduced to travel to other inhabited private homes (described in this same FAQ, below). Transfers to other municipalities are only allowed for proven work needs, situations of need or health reasons. Returning to one’s residence, domicile or home is always allowed. As of January 16, 2021, the exclusion of the so-called second homes located inside and outside the region from the number of their homes that can always be returned (see the specific FAQ). The so-called “curfew” is also in force: from 10 pm to 5 am, only trips motivated by proven work needs, situations of need or health reasons are allowed.

In any case, anyone living in a municipality with up to 5,000 inhabitants can move, between 5:00 a.m. and 10:00 p.m., within 30 km of the limit of their own municipality (therefore, possibly also in another autonomous region or province), even for visits to friends or relatives in the already described way, however, with the prohibition of moving to the provincial capitals.

Respiratory protection devices (better known as masks) must be used both outdoors and indoors in places other than your home, except in cases where isolation for each person who does not live together is guaranteed.

The obligation is not intended to:

  • children under 6 years old;
  • people who, due to their disability or pathology, cannot wear the mask;
  • operators or people who, in order to assist a person, exempt from the obligation, cannot in turn wear a mask (for example: they have to speak at the L.I.S. with a deaf person).

In addition, the use of a mask is not mandatory, both outdoors and indoors:

  • while doing sports activities;
  • while eating or drinking, in the places and times when it is allowed;
  • when you are alone or exclusively with your partners.

Regarding the performance of work activities, the mask is mandatory in the situations provided for by the specific protocols of the sector.

Related to the management of research studies

AIFA Communication (update of AIFA press releases published on March 12 and April 7, 2020): Management of clinical trials in Italy during the COVID-19 emergency (coronavirus disease 19), Version 3 of the September 17, 2020. At the time of this update, a review of all the measures issued by AIFA has been carried out.

July 10th, 2020

Since the last DPCM Decree of April 26, 2020 there has been no official change of instructions and directives since the Italian Government although some activities not allowed at the beginning of May, are now allowed.

National trips (within Italy) are allowed for any reason and from the second half of June 2020.

Leon Research employees have been able to visit again hospitals to perform monitoring visits for the Italian projects.

As a summary, the activities allowed and not allowed as of July 9, 2020 are listed below.

In the Covid-19 emergency period, our activity has been considered essential activities for the measures adopted within the pharmaceutical sector.

is considered essential activities for the measures adopted within the pharmaceutical sector.

Phase II – Permitted Activities:

  • Travel anywhere in Italy and outside Italy in countries that allow access to Italian people;
    • Move between regions without any restriction and for any reason;
    • Perform individual physical activity outdoors and away from home;
    • Professional training and individual sports;
    • Go to parks and gardens and use the play areas;
    • Attend funerals (max 15 people);
    • Reopen construction sites;
    • Go to the second houses;
    • Eating in restaurants, bars and places in general;
    • Go to the hairdresser or beauty centers;
    • Make purchases in stores;
    • Go to mass in churches with a mask.
    • Go to museums, cinemas or libraries.
    • Make private parties without buffet.

Phase II – No Permitted Activities:

  • Use public transportation and be indoors without a mask

Related to investigational studies management

The document “Guidances to manage clinical trials No.6gathers the information contained in the guide with specific measures for the management of clinical trials in Italy, issued by AIFA on April 7, 2020, version 2.

The local applied measures will be communicated to all the parties involved, as well as to the promoters who request it, and taking into account all subsequent updates if necessary.

At the time of this update any review of the AIFA issued measures has been made.

June 1st, 2020

The DPCM Decree signed on April 26, 2020 includes the instructions and directives for Phase II that will start on May 04, 2020.

As a summary, the activities allowed and not allowed as of May 4, 2020 are listed below. Our activity is considered essential activities for the measures adopted within the pharmaceutical sector.

Phase II – Allowed activities:

  • Visit family members and Friends who live in your same region;
  • Move from one region to another only for proven reasons of work, health and absolute urgency;
  • Return to your own home or residence;
  • Do individual physical activity outdoors and away from home;
  • Professional training and individual sports;
  • Go to parks and gardens;
  • Attend funerals (max 15 people);
  • Reopen construction sites.
  • Go to the second houses;
  • Eat in restaurants, bars and places in general;
  • Go to the hairdresser or beauty centers;
  • Make purchases in stores;
  • Go to mass in churches with a mask.

Phase II – Activities NOT allowed:

  • Make private parties;
  • Use the play areas in public parks and gardens;
  • Go to museums or libraries;
  • Use public transportation without a mask;

Related to investigational studies management

The document Guidances to manage clinical trial-COVID-19_No.5_01June2020″ gathers the information contained in the guide with specific measures for the management of clinical trials in Italy, issued by AIFA on April 7, 2020, version 2.

The local applied measures will be communicated to all the parties involved, as well as to the promoters who request it, and taking into account all subsequent updates if necessary.

At the time of this update any review of the AIFA issued measures has been made.

May 4th ,2020

The DPCM Decree signed on April 26, 2020 includes the instructions and directives for Phase II that will start on May 04, 2020.

As a summary, the activities allowed and not allowed from May 4, 2020 are listed below.

Phase II – Allowed activities:

  • Visit family members who live in your same region;
  • Buy food and drinks to take away without consuming them in front of the locals to avoid the formation of groups of people;
  • Move from one region to another only for proven reasons of work, health and absolute urgency;
  • Return to your own home or residence;
  • Do individual physical activity outdoors and away from home;
  • Professional training and individual sports;
  • Go to parks and gardens;
  • Attend funerals (max 15 people);
  • Reopen construction sites.

Phase II – Activities NOT allowed:

  • Visit friends, make family gatherings and private parties;
  • Go to the second houses;
  • Eat in restaurants, bars and places in general;
  • Use the play areas in public parks and gardens;
  • Do sports activities in group or 1 vs 1;
  • Go to museums or libraries;
  • Use the public transport without a mask;
  • Go to the hairdresser or beauty centers (they will remain closed until June 1, 2020);
  • Make purchases in stores (stores which are considered non-essential will remain closed until May 18, 2020);
  • Go to mass in churches.

Related to investigational studies management

  • The document Guidances to manage clinical trial-COVID-19_No.4_04May2020” that gathers the information contained in the guide with specific measures for the management of clinical trials in Italy, issued by AIFA on April 7, 2020, version 2. The local applied measures will be communicated to all the parties involved, as well as to the promoters who request it, and taking into account all subsequent updates if necessary.
  • At the time of this update any review of the AEMPS issued measures has been made.

April 15th ,2020

The DPCM Decree signed on April 10, 2020 officially extends the duration of the state of alarm and confinement until 3 May,2020 and confirms that all industrial and commercial production activities are suspended, with the exception of those considered essential.

Our activity is considered as essential activitites for the measures adopted within Pharma sector.

The document ” Guidances to manage clinical trial-COVID-19_No.2_03Apr2020″ gathers the information contained in the guide with specific measures for the management of clinical trials in Italy, issued by AIFA on April 7, 2020, version 2.
The local applied measures will be communicated to all parties involved, as well as to the sponsor who request it, and taking into account all subsequent updates if the case arises

The action procedure included in the contingency plan for the different scenarios was adopted for one employee who has symptoms of disease during her teleworking activities. The measures have been adopted in the benefit of the worker’s health and the health and safety of the rest of employees, if the case arises.
The procedure to get a back up is activated and the impact in the spceific activities has been minimal.

April 03rd ,2020

The government has extended the duration of the state of alarm until April 13, 2020 and possible extension until May 2, 2020.

The DPCM Decree signed on March 22, 2020 establishes that all industrial and commercial production activities are suspended, with the exception of those considered essential.

Our activity is considered as essential activitites for the measures adopted within Pharma sector.

The document “Guidances to manage clinical trial-COVID-19_No.2_03Apr2020” contains the information including in the guide with specific measures for the management of clinical trials in Italy, issued by AIFA on March 12, 2020. The local applied measures will be communicated to all parties involved, as well as to the sponsor who request it, and taking into account all subsequent updates if the case arises.

No update to guide issued by AIFA on March 12, 2020 with specific measures for the management of clinical trials in Italy until till date.

The action procedure included in the contingency plan for the different scenarios is adopted for one employee who has symptoms of disease during her teleworking activities. The measures will be adopted in the benefit of the worker’s health and the health and safety of the rest of employees, if the case arises.

The procedure to get a back up is activated and the impact in the spceific activities has been minimal.

Previous update of March 25th, 2020

New DPCM Decree signed on March 22nd, 2020. Whose Decree establishes that:

  1. All industrial and commercial production activities are suspended, with the exception of those considered essential.
  2. It is forbidden for everyone to move by public or private means of transportation to a different municipality from the one they are currently in, except for proven work or absolute emergency needs or for health reasons. The authorization for returning home is cancelled.
  3. The production activities that would be suspended in accordance with letter a) may in any case continue if they are organized remotely or telework.
  4. Public utility services are still allowed, as well as essential services. It is maintained the suspension of services open to the public, such as museums and other cultural institutes and places, as well as services related to education when they are not provided remotely within the limits currently allowed.
  5. The production, transportation, marketing and delivery of medicines, health technology and medical-surgical devices, as well as agricultural and food products, are still allowed. Any activity that is functional to deal with the emergency is also allowed.
  6. The activities of the aerospace and defence industry are permitted, as well as other activities of strategic importance for the national economy, subject to the authorization of the Mayor of the province where the production activities are located.

The workers located in the Italian office, in Turin, have been teleworking since March 9th, 2020 and, according to the directives of the Italian Government, will continue to do so until April 3rd, 2020.


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