1. CTMB Guidelines (Rev. October 2006) Section 5: Conducting the Quality Assurance Audit

2. Source Documents Used to verify protocol compliance and data submitted May include items such as: Inpatient and/or outpatient medical records Dx reports such as CT scans, CXR, EKG, etc Pathology and lab reports PE & progress notes

3. Source Documents Any patient record that is signed and dated by a healthcare worker assessing the patient Patient diaries DARFs Study drug invoices and returns Appropriately signed and dated ICF IRB documents and correspondence

4. Audit Findings Three sections to an audit report: 1) IRB and informed consent content 2) Pharmacy review & use of NCI DARFs 3) Patient case review

5. Audit Findings Each of the three elements will receive a rating of: 1) Acceptable 2) Acceptable Needs Follow-up 3) Unacceptable

6. Audit Findings Written corrective action plan is required for any element that receives an Acceptable Needs Follow-up or Unacceptable The CALGB Central Office must approve the action plan before submission to CTMB Re-audits are required for any Unacceptable rating w/n 1 yr or sufficient accrual

7. IRB Element A minimum review of the following is required for each audited protocol Full board initial approval prior to first registered patient Full annual review if study is open to enrollment or patient receiving active tx All updates that affect more than minimal risk w/n 90 days of group notification

8. IRB Element External IND safety reports that are unanticipated and > grade 3 attribution – unless the institution’s IRB has a local policy does not require report of these events. (CO approval of these policies must take place before audit.)

9. IRB – Consent Content The content of ICFs must be reviewed from a minimum of 3 protocols and must include the elements listed in the Code of by Federal Regulations All side effects and alternatives to treatment listed in the model consent forms must also be in each consent form since they are NCI approved consents

10. Pharmacy Audit A member of the DAC will perform an audit of the pharmacy when study supplied drugs are involved. Section 5.3 lists all procedures required for drug storage and accountability along with a list of compliant vs. non-compliant elements.

11. Patient Case Review A minimum of 10% of cases will be audited since the last audit Categories to be audited: Signed and dated ICF Eligibility Protocol directed treatment, treatment sequence, and dose delays or adjustments Disease response Treatment side effects Quality of data collection

12. Patient Case Review The responsible investigator and/or a designee should be available to auditors at all times to help locate data and answer questions. Source documentation that is not available at audit time can be supplied to the team leader within two weeks to be included in the audit findings.

13. Exit Interview An executive session will take place between auditors only prior to the Exit Interview to prepare discussion of pre- liminary findings. The team leader will lead the discussion at the Exit Interview, however the additional auditors may be asked to provide clarification or feedback on patients audited.