Expiration and Renewal of Generic Materials

Approved generic items are generally valid for one year. When the anniversary date approaches, WCG IRB staff will contact the submitter and inquire if renewal is desired. WCG IRB will conduct an annual review of the item if a response is not received by the date cited in the correspondence to ensure continued use is valid and under IRB oversight. Study Renewal Review fees apply. Expired generic items cannot be used. To prevent unnecessary renewal reviews, notify WCG IRB when use of the generic material has ended.

Occasionally, the Board may modify an item during the renewal review, usually due to changes in regulatory guidance or Board policy. Board-directed modifications are indicated in the approval documentation provided to the submitter.