Hold on Study Accrual or Other Study Activity      June 2006

Various entities [including the UCSF PI, the CHR/HRPP, a UCSF oversight entity such as the Cancer Center or GCRC/PCRC, the study sponsor, the VAMC, the FDA, etc.] may place a hold on study accrual or other study activity. A hold is sometimes also called a “suspension” or “pause”.

With one exception, any hold that is placed on study accrual or other activity is reportable to the CHR as an Incident. The one exception occurs when the CHR application and/or the sponsor’s protocol submitted to the CHR includes a planned hold on accrual/activity. For instance, the CHR-approved protocol may indicate that after accrual of n subjects, accrual will cease until a safety analysis can be completed, after which accrual may re-start unless a safety issue is discovered. Thus, a planned hold and subsequent resumption of study accrual/activity need not be reported to the CHR as it has already been approved by the CHR. However, if a planned hold yields new safety information or any other unanticipated problem, or necessitates a change to the consent form or CHR application, then it should be reported to the CHR.