Quality Assurance & Audits
The purpose of the Quality Assurance Program is to enhance the reliability and validity of clinical trials data through routine monitoring. Audits are designed to provide assurance that the data reported on research records accurately reflect data in the primary patient record and to verify compliance with protocol and regulatory requirements. The program also surveys data management practices at each institution to provide educational support to clinical trial sites regarding data quality, management, and more.
The following resources can help with clinical trials quality assurance and the audit process.
Guidelines Regulatory Guidance FDA Inspections
Investigational Agents and Pharmacy Audit Resources
Additional Resources Volunteer Auditor Program
Audits of SWOG Cancer Research Network institutions are conducted in accordance with the guidelines below:
Clinical trials operate under the policies and regulations of the federal Department of Health and Human Services' Office for Human Research Protections (OHRP).
- Human Subjects Protection: OHRP provides leadership in the protection of the rights, welfare, and well-being of subjects involved in research conducted or supported by the U.S. Department of Health and Human Services. OHRP helps ensure this by providing clarification and guidance, developing educational programs and materials, maintaining regulatory oversight and providing advice on ethical and regulatory issues in biomedical and social-behavioral research.
- SWOG Regulatory Guidance, July 2021: Guidance for a successful regulatory audit including expectations of the audit team for IRB, consent form content, Delegation of Task Log, and patient informed consent.
- OHRP Guidance on Changes in Informed Consent Documents and Continued Enrollment of New Participants, April 2008: Changes in informed consent documents in NCI/CTEP-sponsored clinical trials and the continued enrollment of new participants to those trials when new or modified risk information is discovered.
- OHRP Correspondence, September 2008: Section E describes information in regard to Communication of New Risk Information to Subjects Already Enrolled in a Clinical Trial Without Obtaining IRB Approval
- FDA Guidance on AE Reporting, January 2009: Guidance on reporting of external adverse events to IRBs.
- OHRP Guidance on AE Reporting, January 15, 2007: Guidance on reporting of external adverse events to IRBs.
Guidance on preparing for an FDA inspection. Potential FDA registration studies that could be submitted to the FDA under a New Drug Application (NDA) include LungMAP, S1400, S1404, S1418, S1605, S1806, and S1914.
Accountability of Investigational Agents and Pharmacy Operations
Drug accountability and storage procedures described in this section are required under Federal Regulations and CTEP, DCTD, NCI policy.
- ORP Manual: Drug Ordering and Maintenance: Chapter 6 of the ORP Manual provides detailed instructions on completing the NCI Drug Accountability Record Form (DARF).
- NCI Pharmaceutical Management Branch Policies: Pharmaceutical Management Branch (PMB) Guidelines on the management of investigational agents.
- SWOG Investigational Agent Handling Training: Guidance on the proper handling of investigational drugs and is recommended training for new staff involved in ordering, accounting for, and disposing of investigational drugs is accessible to SWOG members via the SWOG Investigational Agent Handling Course (or individual modules) maintained in the ExpertusOne learning management system.
- NCI-PMB Investigational Drug Handling Slide Show: A PMB training module that addresses the investigational drug handling process and CTEP's specific policies for maintaining investigational agents.
- Drug Accountability Record Forms (DARFs): The Drug Accountability Record Forms in this section are required under Federal Regulations and CTEP, DCTD, NCI policy.
- NCI Investigational Agent Record Form (Non-Oral): The NCI DARF must be used to account for all non-oral investigational agents used in NCI sponsored studies.
- NCI Investigational Agent Record Form for Oral Agents: The NCI DARF must be used to account for all oral investigational agents used in NCI sponsored studies.
In order to be consistent with standard medical care and to be compliant with Federal regulations, each investigator participating in trials must prepare and maintain adequate and accurate source documentation designed to record all observations and other data pertinent to the investigation of each participant (21 CFR 312.62.b).
- Site Preparation for an Audit: Guidance on how to prepare for a quality assurance audit
- Policy on Auditing Electronic Medical Records: Guidance on providing access and facilitating the audit process if auditors will be expected to review patient records in the EMR.
- SWOG Patient Chart Review Guidance: Tips for a successful patient case review audit including expectations of the audit team for eligibility, treatment administration, toxicity assessment, endpoint assessment, patient informed consent and general data quality
- Best Practices for SWOG Studies: Current information related to expectations for protocol compliance, documentation practices, and consenting issues for those participating on SWOG studies
- FAQs: Answers to common questions about record-keeping, data entry and more
- Record Retention Guidance: Requirements for record retention of IRB and research records
- Internal QA Program: Guidance on implementing an internal QA Program within the research setting
- Site Authority Log: This log covers studies that do not that do require a Delegation of Task Log (DTL) available on the CTSU website. All staff who participate in the research process for SWOG and CTSU clinical trials must sign this log which indicates what responsibilities they have authority to perform. The Principal Investigator must sign this form to certify that site staff are trained and qualified to perform the specified duties for NCI Sponsored Protocols. This log must be made available during SWOG audits so that auditors may determine areas of responsibility and verify signatures or initials on data if questions arise during the audit process. Investigators, Advanced Practice Providers, CRAs, Research Nurses and other research personnel should sign it but it is not necessary to include pathologists, surgeons or other medical staff such as residents, infusion nurses and lab personnel whose primary duties are within their scope of practice but not related to research activities. Investigational pharmacy personnel should also be included. During an audit, it is expected that the majority data reviewed would be collected by people who have signed the log. A local version of the log may be used in place of this form provided it includes the required information.
Volunteer Auditor Program
The Quality Assurance Department is recruiting nurses and CRAs to serve as volunteer auditors for treatment audits. Nurses must have a minimum of 2 years of research experience and CRAs must have a minimum of 3 - 5 years of research experience. Auditors will work with a representative from the SWOG QA Department. SWOG covers all travel expenses, and auditors are eligible to receive ICS points on their grant continuation for every audit in which they participate.