How to submit amendments, new documents or update fields of a submission?

Update, 23.01.2025

The article below explains the update procedure for projects initially submitted through BASEC.

Preliminary notes:

Use the form SAFETY FORM to submit safety documents and follow the instructions given in the FAQ 'Submission of safety reports (SUSARs, SAEs, ASR/DSUR etc.)'.

During the evaluation of a project by the ethics committee(s), your project is locked, but remains visible in your account.

If you need to send an urgent update and your project is currently locked, contact the ethics committee by email or phone. The contact details of the ethics committee are available from swissethics.ch / ethics committees.

The project form is located in "My account" --> "Manage my applications".

After the Evaluation the ethics committee unlocks the project and you may open it from your account to submit additional or new documents, or to edit and submit new information in form fields. 

Remember to update the information on screen 4. SNCTP, if the submitted update to the project also changes the answers to the questions on screen 4. SNCTP E.g. in case of an amendment that modifies the inclusion/exclusion criteria, or in case new sites are opened or participating sites are prematurely closed, etc ... If changes to screen 4. SNCTP are done, remember to tick Changes to SNCTP information on screen 14. Submission summary before submitting.

How to update your project (amendments, reports, changes etc.)

Depending on the situation you may replace existing documents or add new documents leaving the former versions in place.

Remember to give a short description of the update at the comment field on Screen 14. Submission Summary.
For revised documents: Upload one version in track-change mode where all suggested changes are marked and one clean version with the changes accepted.

Each update scenario is covered in the next few paragraphs. A subsequent submission can involve any combination of the cases outlined here.

Note: In document categories with a star *, at least one document has to be present to be able to submit. For technical reasons this has to be the first document in the category. If you need to replace or delete the first document in a required category, you therefore need to upload the replacement in the first upload space. In case the first document just needs to be deleted with no replacement, and there are already other documents in the category, please do the following:

• Download one of the documents in the category that should stay in the submission
• Delete the just downloaded document in the form
• Delete the document in the first line of the category
• Upload the previously downloaded document to the first line in the category
• enter date (and version if necessary) for the just uploaded document

1. The new documents replace documents that were previously submitted

Note: Documents you delete will be removed from your project form, but the ethics committee(s) can still access them if needed.

1. go to your account-->manage my applications
2. find the project you want to update and click on Update
3. go to the relevant Upload-Screen Screen (Screen 6 for the updates concerning the main research site, Screens 7 to 13 for updates concerning local sites)
4. click on the relevant document category to expand it. You will see your already submitted document(s) from previous submission(s)
5. click on the delete button near the document you want to replace and confirm the dialogue
6. upload the new document and add the new document's date (and version if required)
7. repeat steps 3 to 6 as needed
8. move on to the Submission Summary screen, enter a short description of your update at the bottom of the screen, and click on Validate and send.

2. The new document(s) is/are submitted in addition to (an)other already submitted document(s) of the same category (all should remain valid)

1. go to your account-->manage my applications
2. find the project you want to update and click on Update
3. go to the relevant Upload-Screen (Screen 6 for the updates concerning the main research site, Screens 7 to 13 for updates concerning local sites)
4. click on the relevant document category to expand it. You will see your already submitted document(s) from previous submission(s)
5. click on add another document on the bottom of the document category. (*)
6. a new set of upload controls shows. Upload the new document and add the new document's date (and version if required)
7. repeat steps 3 to 6 as needed
8. move on to the Submission Summary screen, enter a short description of your update at the bottom of the screen, and click on Validate and send.

(*) If you exceed the maximum number of uploads for a document category, delete some of the documents submitted to the ethics committee with a preovious submission. This will release new spots for the new documents.

3. The new documents belong to a category that was empty until now

1. go to your account-->manage my applications
2. find the project you want to update and click on Update
3. go to the relevant Upload-Screen (Screen 6 for the updates concerning the main research site, Screens 7 to 13 for updates concerning local sites)
4. click on the relevant document category to expand it. You will see your already submitted document(s) from previous submission(s)
5. click on add a document on the bottom of the document category
6. a new set of upload controls shows. Upload the new document and add the new document's date (and version if required)
7. repeat steps 3 to 6 as needed
8. move on to the Submission Summary screen, enter a short description of your update in the bottom of the screen, and click on Validate and send.

4. A form field needs to be updated

Note: Information you replace will be removed from your project form, but the ethics committee(s) can still access it if needed.

1. go to your account-->manage my applications
2. find the project you want to update and click on Update
3. go to the Screen(s) with the field(s) you need to update
4. update the fields
5. move on to the Submission Summary screen, enter a short description of your update in the bottom of the screen, and click on Validate and send.

How to submit a request for the extension of the project

An extension of the project because the expected start was delayed, or because the recruitment period was extended, is submitted to the ethics committee as a non-substantial amendment. 

However, if the extension of the project means a prolonged participation of the single participants in the project (for example, a prolonged period of treatment, addition of hospital visits for the participants, ...), this change requires a change to the research protocol. This change is submitted to the ethics committee as a substantial amendment. 

Both extensions of the projects may require a change to the insurance (extension of the period covered).

1. go to your account-->manage my applications
2. find the project you want to update and click on Update
3. go to Screen 2. Project details and enter the new expected "end date"
4. go to Screen 6. Lead EC and upload a Cover letter and/or the updated project protocol indicating the reasons for the request
5. Upload the updated insurance certificate on Screen 6, if applicable
6. go to Screen 14. Submission Summary screen, tick the checkbox 3.2 or 3.3, as appropriate, enter a short description of your update in the bottom of the screen, and click on Validate and send.

Reminders of the definition of end date of the project:

Clinical trials conducted under ClinO or ClinO-MD: The completion of a clinical trial marked by the last participant's final follow-up visit, in the absence of provisions to the contrary in the protocol (art. 38 ClinO, art. 36 ClinO-MD).

Research projects conducted under chapter 2 HRO: The completion of a research project under this chpatre is marked by the last collection of health-related personal data or the last sampling of biological material in a researhc project, in the absence of provisions to the contrary in the protocol (art. 6a HRO).