Strict rules need to be followed when submitting research to the METC in order to ensure high quality research. Many PhD’s have experienced delay in this process due to mistakes in the submission that were probably made before by many others. Knowledge of these frequently made mistakes can help PhD’s to avert these mistakes beforehand and get their METC approval faster.
Therefore, we have
made an overview of the most frequently made mistakes in research submission to
the METC. This overview was set up in collaboration with the Erasmus MC METC.
The Erasmus MC METC checks the submitted research according to the CCMO guidelines. Strictly following these guidelines can prevent a lot of mistakes.
Mistakes in research submission are most often technical in nature. Most mistakes are made in the following rules:
- Document category codes, document names, document version numbers and document dates need to be filled in correctly and the same in both the title and the footnote.
- Documents need to be complete and readable.
- Documents cannot be in word but have to be delivered in pdf format.
- Scanned documents cannot be delivered as a an “image” but have to be provided in pdf format as well.
- It is mandatory to mention the document version and date in the right column in the METC management system. This version and date has to be the same as the ones mentioned in the title of the document.
- The mandatory signatures (head of the department and the principal investigator) need to be included on the ABR form and the research protocol.
- CCMO provides standard templates for different documents such as the patient information folder and the research protocol. For these documents, the latest version of these templates have to be used.
- When CCMO templates are adjusted, the paragraph numbers and titles have to remain the same. Extra subparagraphs can be added but existing subparagraphs cannot be removed. Fill in N.A. (not applicable) when a certain paragraph is not applicable to your research.
The METC has guidelines for WMO, nWMO and local permission submissions. You can e-mail email@example.com and ask for these guidelines.