Assessment of gene therapy research by the CCMO Central Committee on Research involving Human Subjects (Central Committee on Research involving Human Subjects ) is subject to a statutory deadline of 90 days.
The official assessment of the research file by the CCMO starts as soon as all documents have been received (see step 1 in the CCMO flow chart). With respect to deadlines of CCMO meetings, please take into account the time needed for the Gene Therapy Office to forward the documents. An overview of the documents required is given in the research file section. Once the research file has been received, the applicant will receive confirmation of receipt stating the assessment deadline. A research file that is complete at least 2 weeks prior to the CCMO meeting will be discussed in that meeting. (The Gene Therapy Office has no role to play in this phase because the CCMO will itself assess the file’s completeness and ask questions if necessary). After discussion of the application during the meeting (step 3 in the flow chart), the applicant will receive a letter that will include questions from the committee, if any (step 4 in the flow chart). The letter will refer to a deadline by which a response from the applicant is expected. After receiving the response, the CCMO will examine whether the questions have been answered satisfactorily. The research file may then be discussed again in a subsequent CCMO meeting. Assessment of gene therapy research by the CCMO is subject to a statutory deadline of 90 days (step 5 in the flow chart).
Diagram of the CCMO’s gene therapy assessment procedure.