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.

These resources can help with clinical trials quality assurance and the audit process.

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.
  • IRB Implementation Dates, December 2016:  Timeframes for implementing protocol and consent form changes for sites using the CIRB. Also includes new timeframes for implementing eligibility changes for sites not using the CIRB.
  • 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 S1400, S1404, S1418 and S1605. All institutions participating in these studies must maintain a study-specific Trial Master File in order to be inspection ready.

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.

  • SWOG Investigational Agent Handling Video:  Guidance on the proper handling of investigational drugs and is required training for new staff involved in ordering, accounting for, and disposing of investigational drugs.
Drug Accountability Record Forms (DARFs)

The Drug Accountability Record Forms in this section are required under Federal Regulations and CTEP, DCTD, NCI policy.

Patient Case Records

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).

  • 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
  • Internal QA Program:  Guidance on implementing an internal QA Program within the research setting
  • Site Authority Log:  All staff who participate in the research process for SWOG and CTSU clinical trials must sign this log and indicate what responsibilities they have authority to perform. This log must be made available during SWOG audits so that auditors may verify signatures or initials on data or determine areas of responsibility if questions arise during the audit process. Investigators, CRAs, Research Nurses and other research personnel should sign it but it is not necessary to include residents, pathologists, surgeons or other staff such as lab personnel who draw blood or obtain vital signs unless they conduct protocol-related tasks such as taking a medical history, etc. Investigational pharmacy personnel should also be included. During an audit, it is expected that the majority of 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.