Additional Changes Which Require Submission to WCG IRB
Contact Updates
When research is submitted to us for review via one of our portals (ClinSphere® eReview Manager or WCG IRBNet) the submitter defines who on their team will have access to the outcome documents in the portal – adding and removing access over the life of the research as appropriate.
The Contact Information Update form is primarily used for updating contacts in the IRB’s internal system. ClinSphere® eReview Manager workspace permissions are usually granted by sponsor or site contacts who are workspace managers so please remember to periodically review Connexus study and site workspaces to ensure proper permissions are granted and former team members/employees are removed when appropriate.
WCG IRB can also list a limited number of research team contacts in our internal system, and those distribution contacts are listed on the last page of each Certificate of Action; when a distribution contact listed on the Certificate of Action or a Continuing Review Report Form recipient changes, submit those requests for changes via our Contact Information Update form available on wcgclinical.com. Submitting the Contact Information Update form ensures the IRB has the correct contacts in the IRB’s internal system for notifications or questions.
Administrative Changes
Request review of increases in the number of participants allowed at the specific investigator site if a consent form change is needed.
Minor administrative changes sent to the investigator from the sponsor should generally be submitted to WCG IRB for review as “Administrative Letters” or “Administrative Changes.” This type of change might consist of sponsor notifications of changes to the status of the protocol (such as completion of enrollment, completion of a cohort, ending development of a test article).
The above list is not an exhaustive listing of the changes in research that may need to be reported to WCG IRB. If you are in doubt about submitting a particular item, call Client Care at 855-818-2289 or e-mail clientcare@wcgclinical.com.