CRS conducts monitoring according to the NCI-approved Institutional Data Safety and Monitoring Plan. All clinical research studies that are not monitored by another entity will be monitored by Clinical Research Support. The frequency and the scope of the monitoring are determined by the risk level of the study. All studies that support an IND held by a Consortium investigator, are Phase I studies, or meet the NIH definition of high risk are monitored twice per year. All other studies are monitored annually.
Noncompliance and Unanticipated Problems
FHCRC/Cancer Consortium Institutional Review Office (IRO) definitions and policies regarding unanticipated problems can be found here.
Examples of noncompliance or unanticipated problems that may need to be reported to the IRB and the FDA:
- Consent irregularities (e.g., a subject did not sign the most current IRB approved consent or study specific procedures done prior to the date and time the subject's signed the consent form).
- Eligibility exceptions made prior to IRB approval
- Study drug/product dosing errors
- Oversight of SAE expedited report