Clinical trial teams expect scrutiny from several audiences, including stakeholders and regulatory authorities. During a compliance auditing session, clinical trial teams, medical affairs teams, and others involved in the work must be able to provide complete, consistent, and accurate documentation upon demand — often on very short notice.
Choosing the right tools can help teams ensure their work is ready for scrutiny during a compliance audit. IRMS MAX by Anju offers tools to meet the demands of auditors.
Challenges in Compliance
Compliance auditing requirements and standards developed over time, as researchers and regulators realized that clinical trial teams required guidance and standards to maintain the integrity of clinical trial data. For instance, the National Cancer Institute (NCI) did not implement an on-site auditing requirement until 1981 — and not until after an investigation revealed that an NCI-funded research institution had committed scientific fraud, write Raymond B. Weiss and Susan S. Tuttle.
Audit trails help ensure the quality of data collected in a clinical trial by providing context and provenance for the information. A compliance audit checks whether researchers are meeting regulatory requirements.
Compliance itself, however, can prove challenging. In a 2020 study, Sarah H. Snider and fellow researchers outlined the difficulties in compliance with federal guidelines surrounding a study’s appearance on ClinicalTrials.gov. Non-compliant studies shared several features, including:
- Duplicate studies.
- Studies entered in error.
- Failure of investigators to delegate record maintenance or results reporting duties to another upon the investigator’s departure from the research institution.
- Descriptions of outcome measures that couldn’t be understood during the results submission process.
- Results reporting, updates, or start date deadlines that had been missed.
Snider et al. implemented several methods for addressing these difficulties at the Medical University of South Carolina. These included implementing workflows that identified trials with mandated registration, as well as tools to better support collaboration among researchers, IRB teams, and other engaged parties.
Choosing the Right Tools for Compliance Auditing
Work on digitized compliance auditing tools has proceeded for more than a decade. In 2011, researchers Keyuan Jiang and Xiang Cao developed a “comprehensive audit trail system” for use with then-commercially available databases. Jiang and Cao demonstrated that digital tools could create effective audit trails that protected patients’ identifiable information while also providing the information auditors required.
Technology has advanced considerably since 2011, but the challenges of balancing confidentiality and compliance audit demands remain. Today, tools like Anju’s IRMS MAX can help clinical trial and medical affairs teams meet privacy and other regulatory requirements.
Features of IRMS MAX include:
- Centralized Adverse Event and Product Complaints tracking tools. During and after clinical trials, the ability to track adverse event reports and complaints is essential to surviving a compliance audit. IRMS MAX puts these tools front and center with centralized case intake capabilities. Adverse Event and Product Complaint reports allow MA teams to integrate this process with existing information and transfer information to existing safety and complaint departments securely.
- Quality Assurance tools support cross-applications. Co-promoting treatments, applying for new indications for existing products, and communicating with existing vendors and partners can result in information and messaging becoming less consistent over time as it adapts for new audiences and purposes. IRMS MAX includes a Quality Assurance module that makes it easier for teams to coordinate this information — maintaining the consistency required by compliance auditors.
- The ability to scale deployments. IRMS MAX’s “Divisions” feature allows teams to focus on local, regional, and global rollouts of new treatments without losing access to the data-tracking and security tools required for a successful compliance audit.
Compliance audits help ensure that clinical trial, medical affairs, and related teams track and consider the information necessary to demonstrate the quality of clinical trial research data. IRMS MAX helps teams stay on top of the data collection required for a successful compliance audit.
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