Recommendations for the conduct of clinical research at the time of restrictive measures due to the coronavirus
UPDATE 26 May 2020
The following change has been made in CCMO's recommendations for the conduct of clinical research at the time of restrictive measures due to the coronavirus:
- The procedure for notifications to the Dutch competent authority both during and after the study has not been changed. The competent authority will not send a confirmation of receipt for a temporary halt and restart of the trial. However, in contrast to the normal situation, you will not receive a ‘Declaration of no objection’ for this type of notification during the COVID-19 pandemic.
UPDATE 22 May 2020
The following change has been made in CCMO's recommendations for the conduct of clinical research at the time of restrictive measures due to the coronavirus:
- The restart of recruitment of new trial participants after a temporarily halt in recruitment due to COVID-19, the review committee must be notified. In some situations, prior approval from the review committee for restarting the trial is required, for instance the restart of studies in Clinical Research Units.
UPDATE 28 April 2020
The following changes have been made in CCMO's recommendations for the conduct of clinical research at the time of restrictive measures due to the coronavirus:
- A new version of the EU guidance on how to manage the conduct of clinical trials during the coronavirus disease (COVID-19) pandemic has been published today. The main changes concern the distribution of IMP to trial participants, monitoring, remote source data verification and communication with MRECs and competent authorities.
- In addition to the EU guidance, CCMO does not consider logistical changes (e.g. telephone visits instead of physical visits, adjustments to schedule visits), the direct delivery of investigational medicinal products to the trial participant and changes to the monitor plan (e.g. remote monitoring or remote SDV) as a substantial amendment which needs to be approved by a review committee.
- The Healthcare and Youth Inspectorate (IGJ) will also publish a new version of their document with recommendations.
UPDATE 14 April 2020
- Additional recommendations from the Dutch Health and Youth Care Inspectorate.
- The restart of recruitment of new trial participants after a temporarily halt in recruitment due to COVID-19 does not require prior approval by the review committee.
- Oral consent by trial participants for using personal information is necessary before sending IMP to trial participant.
UPDATE 2 April 2020
Information on deferred consent in clinical trials in an emergency situation.