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
Guidelines

Audits of SWOG Cancer Research Network institutions are conducted in accordance with the guidelines below:

Regulatory Guidance

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:  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 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 Inspections

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.

Audit Resources

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
     
Additional Resources
  • 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
  • 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.