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eTMF: The Key to Continuous TMF Inspection Readiness in Clinical Trials
The thought of a freshly-announced audit or inspection sparks an initial wave of anxiety in the minds of a clinical study team. In an instant, questions reflexively arise; how much filing need be done, how will I find the time, what information is missing,…what will the inspector be looking for? These concerns are compounded if we rely upon (or are perhaps onboarding) an eTMF technology that may not allow the ready and easy fixes we’ve been accustomed to. A growing focus on the risks and ownership associated with validated systems, plus the need for better structures in direct eTMF access raise concerns for all. Above all, how can we best ensure data integrity to keep subjects safe? This session will raise and explore the terrain of eTMFs so that you can better plan for a successful inspection.Upon completion of this Webinar, attendees should be able to:
- Identify content for eTMF centralization
- Recognize eTMF features that will facilitate successful inspections
- Understand the challenges and solutions associated with eTMF completeness calculation
Paul Fenton is co-founder, President, and CEO of Montrium and is a leading senior manager in the development, deployment and management of computerized systems for use in regulated clinical trials. His strong background in CDISC and ICH standards and system integrations has contributed to major European and North American standards and platforms in clinical research.
Sholeh Ehdaivand is President and CEO of LMK Clinical Research and is also an internationally-recognized SME in clinical study management and operational documentation management. She carries expertise in the TMF Reference Model, eTMF management, and all facets of clinical trial activities.Registration Cost:
All prices are CDNContact hours:
- $0 - Canadian Chapter members
- $15 - ACRP Global (non-Chapter) members
- $30 - all others
Contact hours have been applied for through ACRP (1.0 CEUs). Membership is not required for online registration of contact hours.To receive contact hours:
Register for the event and attend the program. Log on to ACRP website then click “ACRP Learning Portal” to complete the evaluation between 1-30 days following the event and receive the online certificate.Contact Hour Cost:
Please click here to purchase contact hours. All prices are CDNRefund Policy:
- $0 for Chapter members
- $15 for ACRP Members
- $30 for Non-Members
No refunds or transfers.