Procedure fast-track review by CCMO as review committee
CCMO allows an accelerated review (fast-track procedure) of research files concerning studies on COVID-19 within the authorisation of CCMO. Along with CCMO as a review committee, accredited MRECs and the competent authority have also set up fast-track procedures for the accelerated review of research into the occurrence and/or treatment of COVID-19. The following procedure only applies to a fast-track review by the CCMO as review committee.
- The fast-track procedure is employed in case of urgently needed protection of public health or of a specific population, whereby careful consideration according to the WMO remains guaranteed. This procedure will apply in particular to studies into a vaccine against COVID-19, but can also be used for other interventions/purposes. CCMO reserves the right to disregard the fast-track procedure if she considers the study to be ineligible for this procedure.
- If you would like to make use of the fast-track procedure, you may contact CCMO at email@example.com, stating 'FAST TRACK COVID-19' in the subject matter.
- You must submit the research file digitally. Unlike a regular submission, the fast-track procedure does not involve a deadline.
- Initially, you need only submit protocol, IB and IMPD. The recruitment material and the Participant/Patient Information Sheet including the Informed Consent Form (ICF) may be submitted later, but must be submitted at least 3 days prior to the CCMO committee meeting. The remaining documents may be submitted after the meeting, but must be submitted before the decree by the CCMO is published.
- The (digital) CCMO committee meeting at which the file is discussed takes place approximately within 7 days of receipt of the research file. The sponsor and/or principal investigator will be invited to attend part of the meeting to answer questions from the committee. Some of the questions may already be sent to the investigator prior to the meeting.
- Any remaining questions will be sent within one day of the CCMO committee meeting with a response time set by CCMO.
- The total duration of the review (including submitter response time) is a maximum of 25 days. The current review period depends on the complexity of the study and the urgency required.