What? When the central reviewing committee has approved the amendment, the Board of Directors must give their approval for execution of the research. Before this approval is granted, administrative oversight by the METc Bureau takes place: Is the research listed in the UMCG Research Registry? Are the relevant documents submitted? Have all the for this research relevant and necessary person(s) or departments been informed? For instance, participation of the hospital pharmacy is often required for medical research with (study) drugs.
Who? The coordinating investigator (applicant) submits the relevant documents on a data carrier, such as a USB-drive or CD-ROM, accompanied by a signed application letter which lists the documents being submitted. This should include at least:
- the (primary) approval letter of the reviewing ethics committee and the documents listed therein;
- (if applicable) the additional approval letter of the central ethics committee on the participation of the UMCG, the Research Declaration and the resume of the principal investigator in the UMCG;
- the informed consent letter and informed consent form which will be used in the UMCG;
- (if applicable) a final and signed clinical trial agreement between the UMCG and the sponsor;
The informed consent letter should at least mention the correct contact details of the (principal) investigator(s) in the UMCG.
Where? The administrative oversight is handled by the METc Bureau on behalf of the Board of Directors. The relevant documents for this application can be submitted to the METc Bureau.
Questions? Do you have any questions? Please don’t hesitate to contact one of the employees of the METc Bureau secretariat.