Module 082018: Trial Master Files (TMF) and Investigator Site Files (ISF)


Increasingly rigorous regulatory requirements, dynamic surge of drug development efforts from early stage to late stage clinical trials, and recently updated industry guidelines compiled from 20 plus years of global regulatory inspections has triggered all of us to strive towards developing and implementing robust, fit-for-purpose processes to ensure every company has embedded Quality throughout their respective drug development lifecycle and to be inspection-ready at all times.

This thoughtfully constructed training module is designed to educate Clinical Research Professionals on how to design, implement, and manage the highest quality Trial Master Files (TMF) and Investigator Site Files (ISF). In addition, this module will provide hands-on coaching on how to successfully organize, prepare, process and maintain these essential documents to facilitate successful regulatory inspections

The Academy of Good Clinical Practice (AGCP) Instructors for this training module have been thoughtfully selected and are recognized in the biopharmaceutical industry as Subject Matter Experts (SMEs)working with Clinical Sponsors, Contract Research Organizations (CRO), Service Providers/Vendors, Regulatory Agencies, R&D Organizations, and Drug Development Quality Assurance.

  • Initiation and successful start-up of a new clinical trial and what information is important to take into consideration when establishing a new TMF.

  • Development and implementation of a effective document management plan. Identify the key minimum requirements and what should not be included?

  • Critical metrics to provide meaningful quality indicators before trial initiation, including helpful tools (dashboards and reports) for ongoing completeness management.

  • Management of initial Trial and Central level documentation and establishing an expected documents list.

  • Tracking completeness of filing the clinical trial start-up package for each investigative site.

  • Implementation of a robust Quality Check (QC) process through controlled processes and success indicators.

  • Expectations and impact of implementing ICH-GCP E6 (R2) requirements throughout the essential document lifecycle from study start-up to inspection readiness.

  • Content owner responsibilities and how to improve collaboration with functional areas and senior management.

  • When periodic review of the TMF should be performed and what risks to be aware of in the management of your TMFs. Identifying and appropriately addressing areas of mitigation and risk in a standardized manner.

  • Key elements to consider at the end of study, to include the expeditious, accurate transfer and reconciliation process, including mapping of content residing outside of the main TMF repository.

  • Archival and retrieval of the TMF in a well-organized and process driven process, including outsourcing.

  • Establishing an ISF/Regulatory binder at an Investigative site and determining what is required to be collected and maintained.

  • Best practices for maintenance of the ISF/Regulatory binder and implementation of periodic reviews.

  • Tools and recommendations for collaboration with the clinical site monitor (including CRO) to ensure new documents are collected and reconciled with the TMF in real time.

Scott McCulloch

Suzanne Mayer

Tony Cruz

  • Clinical Trial Assistants (CTA)

  • Clinical Research Associates (CRA)

  • Senior Clinical Research Associates (SCRA)

  • Clinical Project Managers

  • Clinical Trial/Study Managers

  • TMF Specialists

  • Records Associates/Managers

  • Clinical Quality Assurance

  • GCP Auditors

  • Clinical Research Coordinators

  • Clinical Research Organizations (CROs)

  • Principal and Sub Investigators

  • Sponsor Organizations

  • Research Nurses