Working with WCG IRB for IRB Review – An Overview
New protocols submitted to WCG IRB for review (that are not eligible for expedited review) are assigned for review based on the next available panel meeting. U.S. panels meet daily. Reviews for investigators at Canadian locations are assigned to the Canadian panel; therefore, a protocol taking place in both the United States and Canada will be assigned to both U.S. and Canadian panels.
WCG IRB conducts expedited review of certain kinds of research involving no more than minimal risk to human research participants according to federal regulations. In minimal risk research, the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
To learn more about accessing research review details, WCG IRB’s panel structure, or to determine the panel assignment of a protocol, call Client Care at 855-818-2289 or email clientcare@wcgclinical.com.
The protection of confidential business information and trade secrets is vital to the interests and the success of WCG IRB. All employees and board members are required to sign confidentiality agreements as a condition of employment, and WCG IRB follows industry standards on the protection of electronic data in our Part 11 compliant system.
Confidential Disclosure Agreements (CDAs) between sponsors and WCG IRB are not required by WCG IRB. However, we are happy to enter into a CDA if preferred by the sponsor. If you require a CDA, your request will be directed to WCG’s legal department for preparation.
If you are registering research overseen by WCG IRB on Clinicaltrials.gov, use the following information:
IRB Approval Number: [initial protocol approval date mm/dd/yyyy]
Board name: WCG IRB
Board affiliation: WCG Clinical, Inc.
Board address:
5000 Centregreen Way
Suite 200
Cary, NC 27513
Board phone and/or email:855-818-2289 / clientcare@wcgclinical.com
Note: WCG Clinical refers to people who participate in research as “subjects” or “participants.” The term “subject” is more traditional, but “participant” has become more common in recent years. This Guide uses the term “subject” when quoting regulations and federal guidance that use that term or when citing other published materials that use the term “subject,” but otherwise this Guide uses the term “participant” when possible.