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Submitting a study for initial review

Initial Review

All new studies are submitted through the eProtocol web-based study management system. New study submission forms and attachments will be submitted and retrieved through eProtocol. To begin each Sponsor/CRO contact must submit the eProtocol Access Form to be granted access to the system. Please see the Submit Online tab for access into the eProtocol system. The IRBCo Board meets every Monday at 7:00pm PST. The submission deadline is the Wednesday prior to the board meeting at 12:00pm PST. A complete initial submission includes the following:

  •  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 eProtocol system and study personnel who need access to eProtocol to submit or retrieve documents must complete their own eProtocol Access Form. A complete site submission includes the following:

  • Site Application completed in eProtocol
  • 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 eProtocol. 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 eProtocol system. Sponsors/CRO’s and sites will have 24 hour access to the site specific documents.

 

Informed Consent

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 eProtocol 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.