1. Guideline for Monitoring of Clinical Trials for Cooperative Groups, CCOP Research Bases, and the Clinical Trials Support Unit (CTSU) Lore Lagrone Program Director, General Oncology M. D. Anderson CCOP Research Base

2. Practitioners of clinical trials have an obligation to take appropriate steps to protect both the integrity of science and human subjects who participate in research studies Why must we have audits let alone talk about audits?

3. NCI Clinical Trials Quality Assurance & Monitoring As the world’s largest sponsor of clinical trials of investigational antineoplastic agents and cancer clinical trials, the NCI must ensure that research data generated under its sponsorship are of high quality, reliable and verifiable.

4. NCI Auditing Division of Cancer Treatment and Diagnosis (DCTD) Cancer Therapy Evaluation Program (CTEP) Clinical Trials Monitoring Branch (CTMB)

5. Purpose of Auditing Document the accuracy of data submitted to the Cooperative Groups/Research Bases Verify investigator compliance with protocol and regulatory requirements Provide and opportunity for the audit team to share information with the institution staff concerning data quality, data management and all aspects of quality assurance

6. Audit Scheduling Main member institutions will be audited within eighteen months after entry of the first patient. For rapid accrual, the initial on-site audit should be done sooner than 18 months. All institutions (main members, affiliates, CCOPs and components) are eligible for an audit every 36 months but may be selected for audit at any time.

7. Components of Auditing Review of IRB Documentation and Informed Consent Content Review of Accountability of Investigational Agents and Pharmacy Operations Review of Patient Case Records

8. Selection of Protocols & Cases A minimum of three protocols representing studies conducted should be selected Emphasis to the following types of studies: IND, multi-modality, intergroup, designated prevention trials, those with high accrual Minimum cases equivalent to 10% of patients accrued since last audit Unannounced cases Limited review (eligibility/informed consent)

9. Audit Assessments Acceptable Acceptable Needs Follow-up Unacceptable

10. Acceptable No deficiencies identified Few lesser deficiencies identified Major deficiencies identified during the audit that were addressed and/or corrected prior to the audit for which documentation exists and no further action is required

11. Acceptable Needs Follow-up Any major deficiency identified during the audit but not corrected and/or addressed prior to the audit Multiple lesser deficiencies identified

12. Unacceptable Multiple major deficiencies identified A single major flagrant deficiency found Excessive number of lesser deficiencies identified

13. CTMB Guidelines http://ctep.cancer.gov/branches/ctmb/clinicalTr ials/monitoring_coop_ccop_ctsu.htm