|Sponsors and PI’s are responsible for submitting changes to research materials.Study changes may not be implemented prior to receiving IRB approval. Amendments may be submitted to full board following the same timelines listed for Initial Submissions. However, changes to research may also qualify for expedited review. Expedited review items will be reviewed within 72 hours of submission. Your IRB contact will inform you of the type of review your submission will follow. All changes to research must be submitted through AllianceNet. Examples of changes that should be submitted for approval include:
- Study Protocol
- All template consent forms
- Investigator's brochure, package insert, or device background literature for all primary and comparator drug(s) or devices(s).
- Study Questionnaire
- Proposed template recruitment materials (if applicable)
- Proposed study subject materials (diaries, questionnaires, study instruction, etc.)
- Device Study Submission Form (if applicable)
Site Submission Information
Site submissions are reviewed on a daily basis and a complete site submission will have a decision and IRB letter within 72 hours of submission. Site submissions are completed through the AllianceNet system and study personnel who need access to AllianceNet to submit or retrieve documents must complete their own AllianceNet Access Form. A complete site submission includes the following:
- Site Application completed in AllianceNet
- Principal Investigator’s (PI) current Curriculum Vitae (CV)
- Copy of PI’s Medical License
- Proof of Human Subjects Protection training (CITI) for PI and all other key personnel
- Recruitment materials (if available) with site specific information.
A dedicated single-point-of-contact will be assigned to your study at the time of submission. The Board decisions will be communicated the day following the board review. Changes to documents will be made in Tracked Changes for easy identification. Upon sponsor agreement, final documents will be produced and stored in AllianceNet. Site submissions will be reviewed after a complete approval of the initial study submission. Site submissions and IRB approval documents will be managed and maintained within the AllianceNet system. Sponsors/CRO's and sites will have 24 hour access to the site specific documents.
IRBco will review the Sponsor submitted template consent form(s) on behalf of all sites. Once sites are approved, IRBco will prepare site specific consent form(s) and upload them in the AllianceNet system. Site specific changes to previously approved templates must be submitted with tracked changes for IRB review. Several states have specific laws that impose different requirements on the written consent form.