Specific: submitting to the CCMO
Please note: All documents must be submitted digitally until further notice.
If the CCMO is the reviewing committee then the preferred method of submission for all documents concerning the primary submission is digitally on cd-rom. Only the cover letter has to be submitted as hard copy as proof of signature. The signatures in other signed documents on the cd-rom may be inserted or a scan of the originally signed document. You may also submit your file as one single hard copy (unbound). ToetsingOnline is currently being developed to support submission of a complete digital research file, however this functionality has yet to be finalised.
The address of the CCMO is:
Central Committee on Research Involving Human Subjects
F.a.o. the reviewing committee
PO Box 16302
2500 BH The Hague
You are required to submit all digital documents in pdf format. Please save all files separately onto cd-rom (not in folders) and do not use zip files. It is not permitted to submit pdf files that are encrypted, even if the password is provided.
If the CCMO has already assessed an earlier version of the IMPD in the context of another clinical trial, please state this in the cover letter and submit a summary of changes and a track changes version of the IMPD.