When choosing a clinical research technology partner, quality must be a priority throughout the process. In the first part of our two-part quality checklist blog, we share key questions to ask potential eCOA, IRT, and overall clinical trial technology providers. These questions will help you identify a partner who will put your clinical trial on the right path for a quality-first approach, enabling patient safety, data integrity, and regulatory compliance.
Quality Questions to Ask Potential Providers
- How do you enable data integrity and regulatory compliance?
Data quality issues are prevalent in clinical trials and can jeopardize patient safety and regulatory compliance, keeping nearly 50% of clinical trial executives up at night.1 Accurate and reliable data is fundamental for drawing meaningful conclusions from clinical trials and guiding future research efforts.
When evaluating clinical trial technology partners, inquire about their approach to data integrity. Look for an eCOA and IRT system with features such as data entry confirmation for critical information to minimize errors. User access controls (based on roles and permissions) ensure that only authorized personnel can modify data. Regular data cleansing and validation processes are also crucial to maintain data accuracy. Consider the International Council for Harmonisation’s E6(R3) Guideline for Good Clinical Practice (GCP), designed to enable participants’ rights, safety, and well-being while promoting the reliability of trial data.2 - Can you access the audit trail view to see data changes?
Access to an audit trail view for data changes is essential for transparency and accountability in clinical research. Your eCOA and IRT technology partner should provide comprehensive audit trail views that track any modifications made to the data, fostering trust and confidence in the integrity of your results. - How do you identify potential issues before they escalate? What are your turnaround times?
Implementing risk-avoidance strategies delivers substantial benefits, particularly regarding efficiency and data integrity. Traditional 110-day investigation turnaround times can leave sponsors in the dark for months3, hindering timely corrective actions. To counter this, processes must be established to monitor study conduct. Proactive measures for issue identification must be built in advance of study launch to facilitate prompt resolution. These proactive measures should leverage data analytics to identify and mitigate potential issues before they occur. This approach, along with a focus on achieving a 30-day turnaround for CAPA investigations, enables your clinical trial to stay on track, ultimately accelerating timelines and safeguarding the integrity of your research. - If there are corrective and preventive actions (CAPAs), how fast do you typically resolve them?
Your provider must have quality solutions built into the process, minimizing CAPA occurrences. A qualified vendor must show average time in CAPA resolution with a proactive CAPA program that emphasizes early detection with the ability to identify potential issues before they escalate. Look for vendors with a proven track record of swift CAPA resolution, ideally within a specified timeframe (e.g., 30 days). Inquire about their CAPA processes, including root cause analysis, corrective action implementation, and preventive measures, to avoid future occurrences. Ensure the vendor has checks to confirm root causes were accurate and the preventive actions were effective. - What is your standard operating procedure (SOP) management practice?
SOPs are crucial to ensure consistency and minimize errors in clinical research. The approach to SOP management should involve providing a centralized repository for storing and managing all SOPs, complete with version control, to enable compliance with the latest effective procedures. Additionally, user training modules should educate all staff on accessing and adhering to relevant SOPs, promoting adherence to standardized practices throughout the research process. - Is your process documentation up to date?
The right vendor should have a system for regularly reviewing and revising documents to align with the latest standards and practices. Up-to-date documentation not only supports regulatory compliance but also enhances research reliability and accuracy. Confirm that your eCOA or IRT vendor uses specialized software for document management, as this can streamline updates and minimize human error. Additionally, ensure they have a dedicated team responsible for oversight, ensuring all revisions are meticulously tracked and implemented. This commitment to thorough documentation can significantly impact the overall quality and integrity of your study. - How do you ensure training records are well-maintained and compliant with required standards?
Maintaining accurate and up-to-date training records is crucial for regulatory compliance and operational efficiency. Ask about how the vendor tracks these records, their documentation practices, and their procedures for regular updates. Ensure their methods align with industry standards and regulatory requirements to support a well-trained and compliant workforce. Verify that records are easily accessible and that backups are in place for audits and inspections.
By asking these critical questions, you can better assess whether your eCOA or IRT technology partner is truly committed to maintaining the highest standards of quality in clinical research. Look for their track record in quality assurance, investment in cutting-edge technologies, and adherence to regulatory requirements.
Want to learn more? Our comprehensive quality checklist explores the essential quality and experience questions to ask potential technology providers. Plus, get expert tips on evaluating responses and making informed decisions that align with your goals.
Sources
- IRT Trends for Today and Tomorrow Insights From a Survey of Clinical Research Executives. ↩︎
- FDA Guidance Document, E6(R3) Good Clinical Practice (GCP) ↩︎
- GPs Could Be Offered Bonuses To Increase Patient Numbers In Clinical Trials ↩︎
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