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 OBJECTIVE 6: AUDITING

The Office of Human Research Protection and Health and Human Services regulations (45 CFR 46) and Good Clinical Practice (GCP) recommendations apply to all trials that receive funding from a Health and Human Service agency. Trials with a Food and Drug Administration Investigational Drug Application must additionally comply with 21 CFR references.

The CTSU complies with the FDA and OHRP regulations and the NCI/CTEP Clinical Trials Monitoring Branch (CTMB) guidelines to monitor clinical trials and assure data accuracy.

An audit is an examination of data, records, and written procedures to determine accuracy and completeness of the research process and maintenance of current regulatory documentation. The audit provides information to the site staff that should improve the accuracy and reliability of clinical trials data and results.

To review commonly asked questions regarding the audit process, click here.

Module Objectives
1
 Identify specific regulatory documentation, medical records, and laboratory certification that must be maintained according to Federal regulations and Good Clinical Practice
2
 Describe the procedure for submission of data to the CTSU
3
 Implement the procedures to acquire study agents specific for a protocol on the CTSU menu
4
 Demonstrate the procedure for reporting adverse events for patients enrolled through the CTSU
5
 Summarize radiation therapy guidelines that will need to be initiated at the study site prior to enrolling patients on CTSU protocols where radiation therapy is a treatment intervention
6
 Describe the rationale and process for auditing data obtained for patients enrolled on a CTSU protocol
7
 Explain CTSU Quality Assurance