How to submit a request for the extension of the project
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 needs to be 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 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).
BASEC:
- go to your account-->manage my applications
- find the project you want to update and click on Update
- go to Screen 2. Project details and enter the new expected "end date"
- go to Screen 6. Lead EC and upload a Cover letter and/or the updated project protocol indicating the reasons for the request
- Upload the updated insurance certificate on Screen 6, if applicable
- 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 box 'comments, and click on submit.
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 chapter is marked by the last collection of health-related personal data or the last sampling of biological material in a research project, in the absence of provisions to the contrary in the protocol (art. 6a HRO).
Research projects conducted under chapter 3-5 HRO: The completion of a research project under these chapters is not explicitly defined in the ordinance. The project is therefore considered terminated when all activities related to the project have been completed (the publication of the research project results is excluded).