EU has updated their COVID-19 clinical trial guidance that was initially released on March 20, 2020.

Version 2, published on March 27, includes the following key changes from version 1:

Initiating new clinical trials

The feasibility of starting a new clinical trial or including new trial participants in an ongoing trial should be critically assessed by sponsors. Risk benefit section of the protocol shall address additional risks to participants, together with mitigation measures.

Safety Reporting

Sponsors are expected to continue safety reporting in line with the EU and national legal frameworks. When physical visits are reduced or postponed, it is important that the investigator continue collecting adverse events from the participant through alternative means, e.g. by phone.

Changes to informed consent

  • The informed consent procedure in all trials needs to remain compliant with the trial protocol as well as with the EU and national rules.
  • Consent can be given orally by the trial participant in the presence of an impartial witness if written consent is not possible (e.g. due to quarantine)
  • Separate informed consent forms can be signed and dated by the trial participant and the person obtaining consent; all relevant records should be archived in the investigator site’s Trial Master File. As soon as possible, a correctly signed and dated informed consent form should be obtained from the trial participant.
  • In case of acute life-threatening situations, where it is not possible within the therapeutic window to obtain prior informed consent from the patient (or her/his legal representatives(s)), informed consent will need to be acquired later, when this is allowed in national legislation.

In these cases, the investigator is expected to record why it was not possible to obtain consent from the participant prior to enrollment.

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