Knowledgebase
swissethics BASEC submission FAQ > Help Desk > Knowledgebase

Search help:


Submissions concerning old multi-centric projects (pre-BASEC)

Solution

(FORM "PRE-BASEC RESEARCH PROJECT")

For multicentric projects  submitted before the introduction of BASEC, you need to specify how the project was initially submitted. The submission process is slightly different for the two existing options, explained in the following paragraphs: 

Option: multicentric with 1 Lead Ethics Committee

The project was originally submitted according to the swissethics (formerly AGEK) multicenter concept.

The project has a lead Ethics Committee. The applicant submits the documents just once, indicating the lead Ethics Committee and the local Ethics Committees. One Pre-BASEC Form is created and submitted. The Lead EC will liaise with the local ECs if necessary, and will approve the documents for all sites.

Option: multicentric parallel

The project was originally submitted in parallel to each Ethics Committee separately.

The project doesn’t have a lead Ethics Committee. The review of these projects remains to be done in parallel. The applicant submits the documents to each Ethics Committee separately using the Pre-BASEC Form. For example, a study where 5 ECs reviewed in parallel, now 5 Pre-BASEC Forms will be created and submitted. Each EC will approve the submitted documents independently.

 

Notes:

  • As for regular multicentric projects, there is only one „Project Submitter“ who can submit documents to the Ethics Committees. Usually, the Project Submitter is located at the coordinating investigator’s site. The local sites can be invited to the project (see Manage Invitations), however can’t submit.

  • Always use the same form for subsequent updates to the project. If the form is locked please contact the EC and ask it to unlock the form. 
 
Was this article helpful? yes / no
Related articles How to submit amendments, new documents or update fields of a submission?
Submission of PW-protected files
BASEC – Quick start
How to submit information which reveals treatment assignment in a double-blind study (so-called "unblinding information")
How to collaborate on a submission
Article details
Article ID: 18
Category: Submissions/Updates for old projects (pre-BASEC)
Views: 1938
Rating (Votes): Article rated 2.1/5.0 (25)

 
« Go back