UPDATED ON May 5th, 2020

The Spanish Agency for Medicines and Health Products (AEMPS) provides recommendations for exceptional application during the period of the COVID-19 crisis in Spain.
“It is important that the sponsor together with the investigator make a risk analysis and prioritize the activities that are critical and the way in which they should be carried out. Both should evaluate the application of these measures in a proportionate way for each clinical trial”
These measures are intended to preserve the activities of the trial as far as possible, guaranteeing the health care of the patients, protecting their safety and well-being and preserving the traceability of the actions implemented in this health emergency situation.

Any such exceptional measures taken must be duly documented in the trial file. However, its application does not require prior approval on a case-by-case basis as a substantial modification by the AEMPS or by the Ethics Committee for Drug Research (CEIm), nor the individual notification of serious breaches of the protocol, except when expressly required in the point 2.
In the four months following the date in which it is considered that the COVID-19 crisis has ended in Spain, the promoter must communicate for each trial a report on the exceptional measures adopted that will be sent to the Agency and the CEIm.

For any other query to AEMPS related to these recommendations, you can contact:
• Department of Medicinal Products for Human Use: Clinical Trials Area
• Department of Inspection and Control of Medicines: Area of BPC and BPFV
In both cases, URGENT COVID19 should be indicated and priority will be given to the answer.

May 5th, 2020:

Update of the document “ Exceptional measures applicable to clinical trials during COVID-19
emergency”: it highlights the importance of the measures approved by the Council of Ministers of Health
of the EU on April 27, 2020 of exceptional application during the period of the COVID-19 crisis in Spain,
and indicates the specific aspects of its implementation it relates clarification on the following:

  • Patients’ on-site visits scheduled in a clinical trial
  • Recruitment of new patients
  • Access to trial treatment: new permitted procedures of shipment
  • Obtaining of informed consent: new options.
  • Monitoring visits: when to access to sites and source data, procedures..
  • Transfer of patients from one site to another
  • Notification to EC and MoH: new criteria for notification.

For official communication in the local language please visit this website.

Meditrial can help – Contact us for immediate support

Meditrial has developed rapid workflows to conduct risk assessment, implement rescue plans and execute solutions for ongoing clinical trials:

Contact Meditrial for immediate assistance in Europe or the US.