The MREC NedMec does not have a deadline for mail submission, except for new research files and response letters concerning ‘important changes’ as these need to be discussed by the whole MREC chamber (see further below). Mail is processed in the order in which it was received and put on the agenda as soon as possible, depending on how busy the MREC’s schedule is. For new files submitted, you will receive notification of the date of first discussion.
Meeting schedule & timelines uitklapper, klik om te openen
The MREC consists of three chambers which each have two meetings per month:
- Chamber O (Wednesdays in even weeks)
- Chamber A (Tuesdays in even weeks)
- Chamber G (Tuesdays in odd weeks)
Chamber O reviews oncology research, Chamber G reviews other drug researches (and if necessary also researches with Medical Devices), and Chamber A reviews the other researches (and if necessary also drug researches). All three chambers review research with adults as well as research with minors.
Once a research file has been assigned to a chamber, this chamber will also review the response to questions, etc.
Deadlines for submissions and chamber agendas
New files and responses to ‘important changes’ must be in the possession of the MREC at the latest of two weeks before the meeting, on Tuesday or Wednesday at 12:00, due to the processing by the secretariat and the preparation of the meeting.
Files to be discussed will be put on the agendas of the chambers in the order in which they were received. Before a research file is put on the agenda, it is checked for completeness. Incomplete files will not be discussed. The investigator will be informed via e-mail if a file is incomplete.
The MREC’s general chairman and the chairpersons of the three chambers together make up the MREC’s Executive Committee; they meet up every Wednesday
The Executive Committee is authorised on behalf of the MREC to take decisions which have been delegated to the Executive Committee. If a chamber has decided that a few minor changes are required in a protocol, the study will be reviewed during a meeting of the Executive Committee (possibly after consultation with a number of committee members). The review by the Executive Board will take place on Tuesday. This also applies to amendments, SAEs, SUSARs and other correspondence, unless consideration in a meeting of the Chamber is necessary.
When will I hear about the result? uitklapper, klik om te openen
It is only after the first submission of a new research file that the applicant will receive confirmation of receipt, including information on:
- the chamber to which the research has been assigned
- the date of first discussion
- any fees associated with the review
Within 14 days after the meeting, you will receive the MREC’s decision or a request for changes/additions to the research file. This period also applies to documents discussed by the Executive Committee.
The term within which the MREC must decide on your application will be stated in the ToetsingOnline portal. Via ToetsingOnline you can also keep track of the remaining decision period.
Fees for review uitklapper, klik om te openen
The fees for the review of research have changed as of 01-01-2023. A new studie or amendment received before 01-01-2023 will receive an invoice with the 2022 review fees (even though the review took place in 2023).
In the download below the fees for 2023 can be found for research directly submitted to MREC NedMec. For information on the rates for the review of clinical research with a medicinal product (CTR), research with a medical device (article 62/74.2 MDR) and research with a medical device for in-vitrodiagnostics (article 58/70.2 IVDR), please visit the website of the CCMO (Website CCMO - rates).
N.B. For the assessment of a new IMPD or IMDD (per product), regardless of whether this is submitted with a new study or an amendment, a rate is charged in accordance with the national rates of the CCMO (Website CCMO - rates). This also applies if it concerns a medicinal study under the CTD or a study with a medical device that was submitted to the MREC in the past.
Participating institutions: UMC Utrecht, Prinses Máxima Centrum for pediatric oncology and Antoni van Leeuwenhoek