Detail process of the protocol initial submission.
Primary Investigators or Co-Investigators ensure the submission of a complete proposal package based on the CHS IRB Standard Operating Procedure (SOP) checklists. Confirmation from the IRB officer will be sent for the submission of the complete proposal package and registration on the IRB system.
After the successful submission of the protocol, it will be registered either as expedite or full board review or emergency type of review, based on the study type and risk type of the study. Investigators will receive the reviewer’s comment through the system. Investigators shall submit the revised protocol based on the IRB comments within 15 days after receiving the comment. The investigators will receive the approval letter if the reviewers do not have further comments or concerns on the submitted revised version of the protocol.
The documents you need to submit are the following
- Application Form
- Scanned Department support Letter with Original Stamp
- Scanned Department minute and Department REC
- Proposal Document
- Informed consent form (Amharic, English version and language spoken at study site)
- Questioner (Amharic and English and language spoken at study site)
- Other related documents, (optional)
Downloadable documents
We Receive huge number of protocol requests each year
Every year we receive huge number of protocol related requests. The following figures show the number of requests from last year.
Initial Submissions
Amendments
Renewals
Seminars