Do not submit the file until its quality check by the Research Quality Coordinator of your division has been completed. The contents of the file depend on the type of review: collection of human biological material (sub-biobank file) or use of human biological material (release file).
How to submit uitklapper, klik om te openen
Codes, file names and PDF’s.
The file name of each document consists of a letter-number code plus the title of the document in question. For this you can consult the page of the file concerned on this website: ‘File for collection of human biological material (sub-biobank file)’ or ‘File for use of human biological material (release file)’. You should always add the date of the document (dd-mm-jjjj) and, if applicable, a version number (version x.x) to the file name.
All documents must be submitted digitally in PDF format:
- Other file types must be changed to PDF format.
- Please submit the PDF files in searchable form as much as possible (i.e. no scans from paper documents) in order to limit file size and to ensure an efficient review procedure.
- Change Word-documents containing ‘track changes’ to PDF-format by using ‘print to PDF’ to keep changes visible (do not use 'convert' to PDF).
Send all files and correspondence to: firstname.lastname@example.org
Send the complete file via e-mail to the TCBio: email@example.com
Check that all forms that require signing (e.g. the protocol) have been signed by the correct persons. Check that all documents are in the correct format with the correct codes and file names. Requests which have not been submitted properly cannot be processed. The review of the request may be delayed as a result.
Response to Committee questions
Follow the submission instructions in the e-mail accompanying the Committee’s questions. A changed sub-biobank protocol or release protocol needs only to be signed by the responsible coordinator for the sub-biobank or the investigator with final responsibility respectively.
Please submit your response within 1 month of our writing. If this is not feasible, a postponement for a reasonable period of time, including the reason for a postponement, can be requested in writing.
Changes to previously approved sub-biobank or release protocol need to be submitted as an amendment. Please include a summary of the changes as well as a rationale for the changes in the cover letter or in the e-mail. Amendments that do not include a rationale for the changes cannot be processed.
Mark all changes in the approved documents by using the track changes function in Word. Also use track changes in the amended documents to change the document’s version number and date. In this way it can quickly be established during the review process that the correct version has been amended.
Finally, also change the document names (date, version number and if applicable the letter number code).
For more instructions navigate to:
- Sub-biobank file: Collection of human biological material - Toetsingscommissie Biobanken (umcutrecht.nl). Click on ‘File’ on the right side of the webpage and scroll down to ‘Approach for amendments to a biobank protocol’.
- Release protocol: Use of human biological material (release review) - Toetsingscommissie Biobanken (umcutrecht.nl) . Click on ‘File’ on the right side of the webpage and scroll down to ‘Approach for amendments to a release protocol’.
An amended sub-biobank protocol or release protocol needs only to be signed by the responsible coordinator for the sub-biobank or the investigator with final responsibility respectively.
For amendments to sub-biobanks it is also advised to check if changes are still needed in order to comply with the GDPR. For more information go to:
Existing biobanks: Information letter to be changed in connection with the GDPR - Toetsingscommissie Biobanken (umcutrecht.nl)
Do you want to amend more than one file, e.g. a sub-biobank file and a release file? Please submit the amendment for each file separately. The relationship between the amendments can be indicated in the cover letter for each amendment. Always include the related file numbers in the cover letter.
Of interest to know:
Depending on the nature of the changes, an amendment may be reviewed within a committee meeting or outside of a meeting. This consideration is usually made on the Monday of the week preceding the committee meeting. It is advised to take this into account when planning the submission of the amendment. To view meeting dates go to:
Meeting schedule & fees - Toetsingscommissie Biobanken (umcutrecht.nl)