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Avoid Costly TMF Inspection Findings: 15 Key Strategies
Staying inspection-ready is essential for clinical trial success. Our guide, 15 Ways to Avoid Inspection Findings, breaks down key strategies with actionable insights. Each section explains Why It Matters, How It Prevents Inspection Findings, and How Trial Interactive’s Solutions Can Help, ensuring your TMF remains compliant and audit-ready at all times.
15 WAYS TO AVOID INSPECTION FINDINGS
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Create standard operating procedures for trial-related activities.
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Go paperless to ensure all TMF records are maintained electronically.
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Conduct regular internal audits.
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Implement robust quality management solutions.
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Train teams on your system’s best practices and use cases.
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Obtain TMF expert certification through training.
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Attend a TMF Inspection Readiness workshop.
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Conduct and document investigator meetings in a 21 CFR Part 11 compliant system.
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Utilize study owner services to supplement your in-house team.
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Use a clinical trial management system that integrates with the eTMF.
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Complete periodic reviews of TMFs.
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Accelerate site activation.
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Centralize investigative site file management and monitoring.
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Centralize training requirements for all studies through an LMS.
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Implement a solution for clinical study document collaboration.
1. Create standard operating procedures for trial-related activities.
WHY IT MATTERS: Ensures consistency and compliance in all study-related activities and streamlines change management.
HOW IT PREVENTS INSPECTION FINDINGS: Helps prevent non-compliance issues during inspections.
HOW TI’S PRODUCT HELP: TI's SOP development service can help you create effective, compliant SOPs. It helps you navigate the complexity of change management when new SOPs are needed for new processes.
2. Go paperless to ensure all TMF records are maintained electronically.
WHY IT MATTERS: Going paperless ensures that all documents are easily accessible remotely and retrievable and searchable in real-time.
HOW IT PREVENTS INSPECTION FINDINGS: With a contemporaneous TMF, your TMF remains inspection ready instead of requiring active preparation ahead of inspections.
HOW TI’S PRODUCT HELPS: TI eTMF keeps all of your TMF records organized, accessible, visible, and controlled in real-time across all of your studies with reports and dashboards to monitor TMF health.
3. Conduct regular internal audits.
WHY IT MATTERS: An internal audit with more of a GCP focus will assess procedures as well as essential documents anticipated for review as part of a GCP inspection. Mock TMF audits help identify and address any potential compliance issues.
HOW IT PREVENTS INSPECTION FINDINGS: Allows companies to proactively address any issues before they become problems during an inspection.
HOW TI’S PRODUCT HELPS: TI's TMF review services can help you conduct effective internal audits.
4. Implement robust quality management solutions.
WHY IT MATTERS: Quality assurance teams can manage standard operating procedures, policies, guidelines, and any other documents from approved frameworks for business processes as required by the quality management system.
HOW IT PREVENTS INSPECTION FINDINGS: Helps internal QA identify and address any potential compliance issues against a set of policies and procedures before they become problems during an inspection.
HOW TI’S PRODUCT HELPS: TI's configurable and connected Quality Management Solutions securely track and manage incidents, investigations, compliance documents and processes, and more to ensure compliance with regulations. We also help by tracking and overseeing your Quality Management System.
5. Train teams on your system’s best practices and use cases.
WHY IT MATTERS: Ensures that all trial-related activities are conducted in compliance with regulations.
HOW IT PREVENTS INSPECTION FINDINGS: Helps prevent non-compliance issues during inspections.
HOW TI’S PRODUCT HELPS: As part of our TMF Services, we provide best practices for using TI’s systems, as well as use cases to support the training process.
6. Obtain TMF expert certification through training.
WHY IT MATTERS: Ensures that your organization's TMF team members have the necessary knowledge and skills.
HOW IT PREVENTS INSPECTION FINDINGS: Helps prevent non-compliance issues during inspections.
HOW TI’S PRODUCT HELPS: TI's TMF University is the only accredited TMF University in the world and offers expert certified training.
7. Attend a TMF Inspection Readiness workshop.
WHY IT MATTERS: Ensure that your organization's TMF inspection preparation practices are up-to-date and compliant.
HOW IT PREVENTS INSPECTION FINDINGS: Helps prepare for a pending inspection and prevents non-compliance issues during inspections.
HOW TI’S PRODUCT HELPS: TI's TMF workshops provide comprehensive training on the latest industry best practices and trends around GCP inspections.
8. Conduct and document investigator meetings in a 21 CFR Part 11 compliant system.
WHY IT MATTERS: Train investigators on clinical trial protocols and study documents so they can prepare and carry out the protocol during clinical research. If your training is documented and signed with 21 CFR Part 11 e-signatures, findings can be prevented.
HOW IT PREVENTS INSPECTION FINDINGS: Late investigator training and missing qualifications are common inspection findings. By sharing data across training systems, you can easily track, validate and report completed participation.
HOW TI’S PRODUCT HELPS: TI Investigator Meetings improve training oversight and automatically file training completion certifications to the LMS/eTMF to easily prove compliance.
9. Utilize study owner services to supplement your in-house team.
WHY IT MATTERS: Ensure that your organization has the necessary personnel and expertise to maintain a compliant TMF.
HOW IT PREVENTS INSPECTION FINDINGS: Helps prevent non-compliance issues during inspections.
HOW TI’S PRODUCT HELPS: TI's Study Owner Services provide experienced, qualified staff to supplement your in-house team.
10. Use a clinical trial management system that integrates with the eTMF.
WHY IT MATTERS: Helps track and manage study data and timelines effectively.
HOW IT PREVENTS INSPECTION FINDINGS: Helps prevent issues related to data management and timelines during inspections.
HOW TI’S PRODUCT HELPS: TI CTMS enables a single source of truth across the entire life cycle, providing transparency into Trial Interactive solutions and any sponsor or CRO systems of record.
11. Complete periodic reviews of TMFs.
WHY IT MATTERS: Periodic TMF quality reviews are massively important to avoiding inspection findings as they ensure ongoing TMF inspection readiness and a high-quality TMF.
HOW IT PREVENTS INSPECTION FINDINGS: Helps prevent findings related to TMF documents during inspections.
HOW TI’S PRODUCT HELPS: TI’s independent internal quality team is dedicated to TMF reviews, TMF health assessments, and inspection readiness reviews.
12. Accelerate site activation.
WHY IT MATTERS: Site activation is a highly regulated process. You need ways to efficiently collect the required documents from sites, review and approve the collected documents, and submit packages to regulatory authorities.
HOW IT PREVENTS INSPECTION FINDINGS: Reduces risk of noncompliance by using a study start up tool that shows oversight, which is an important part of inspections, and helps you reach drug approval faster.
HOW TI’S PRODUCT HELPS: TI's Study Start-Up solution accelerates site activation with process automation, obstacle mitigation, timeline projection, and simplified regulatory submission.
13. Centralize investigative site file management and monitoring.
WHY IT MATTERS: The ability to conduct remote site monitoring with paperless site file management helps CRAs work more efficiently and meet regulatory requirements.
HOW IT PREVENTS INSPECTION FINDINGS: Maintain digital site files that update in real time in one central location that supports inspection readiness.
HOW TI’S PRODUCT HELPS: TI's eISF reduces administration and improves speed and compliance for site personnel.
14. Centralize training requirements for all studies through an LMS
WHY IT MATTERS: Ensure that all study-related training at site level are conducted and documented in compliance with regulations.
HOW IT PREVENTS INSPECTION FINDINGS: Helps prevent non-compliance issues during inspections.
HOW TI’S PRODUCT HELPS: TI's Site Training provides a regulatory compliant system to track training on regulatory requirements and best practices for site staff.
15. Implement a solution for clinical study document collaboration.
WHY IT MATTERS: Centralize collaborative authoring and approval processes for your clinical study documents in an FDA 21 CFR Part 11 compliant system.
HOW IT PREVENTS INSPECTION FINDINGS: Helps reduce risk of inspection findings by aligning document work streams with regulatory compliance practices for document authoring, approval, control, and related training. It also adheres to FDA requirements for electronic records and signatures, 21 CFR Part 11.
HOW TI’S PRODUCT HELPS: It also adheres to FDA requirements for electronic records and signatures, 21 CFR Part 11.
