Special Considerations for Multi-Center Studies

Each individual submission for a multi-center study must be accompanied by a completed initial review submission (through ClinSphere^® eReview Manager or IRBNet).

Any site submission lacking a complete submission form, current CV and license, or proof of a current medical license (when applicable) may not be scheduled for review until the missing information is submitted. Depending on the type of research, additional information may also be required. Contact WCG IRB for information about submission requirements for specific types of research. 

For new research, the IRB reviews the protocol and related participant materials for each investigator.  Each investigator’s initial approval Certificate of Action cites all the protocol-level items that the IRB has approved for that research (unless we have received instructions otherwise, see below).

Each time a new item is submitted for review for a multi-center protocol, advise us if any documents should be excluded from automatic review for all sites  — identify any documents that should be excluded from default, all‑site approval (e.g., payment‑vendor documents or site‑specific consent forms). In the absence of such notation, WCG IRB will assume the document applies to all sites. Please refer to the “Documents for Select Sites” section of this document for additional information on this process.

If some or all sites will rely on the same billing instructions, it is acceptable to put “see attached” in one of the submission form billing fields and provide them with a completed copy of our “Billing Information Stand-Alone Form” (available on the web site here) to send to us with the submission in lieu of filling out the billing section of the form each time. Initial review submissions lacking either a completed billing information section or the stand-alone form will be placed on hold and missing information requested.