ESSENTIAL DOCUMENTS IN TMF (ICH-GCP E6(R2) REFERENCE) - Qtech-Sol USA offers Clinical Research / Trials, Pharmacovigilance, Drug Safety, Clinical Data Management, Clinical SAS Programming and Healthcare BA Training Programs
Category:
Clinical Research
 
Duration:
3 Weeks / 80 Hours
 
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ETMF: Essential Documents in TMF (ICH-GCP E6(R2) Reference)

Introduction – Trial Master File & Essential Documents

The Trial Master File (TMF) is the cornerstone of regulatory compliance in clinical research. As outlined in ICH-GCP E6(R2), essential documents must be collected, maintained, and archived to demonstrate trial integrity, subject protection, and data reliability.

The ETMF program introduces learners to the scope, structure, and management of essential documents within the TMF. It emphasizes how proper documentation ensures inspection readiness and compliance with international regulations, making this training vital for clinical research and data management professionals.

Course Name :  ESSENTIAL DOCUMENTS IN TMF (ICH-GCP E6(R2) REFERENCE)
(Role based Lessons – Case Scenarios, Job Tasks with Solutions)
Course Code :  ETMF
Experience Level :  Entry to Intermediate
Qualification :  Bachelor’s / Master’s in Life Sciences, Pharmacy, Nursing, Public Health, Regulatory Affairs, or related disciplines
Student Category :  Clinical Research Associates (CRA), Clinical Trial Assistants (CTA), Clinical Data Managers (CDM), Quality & Compliance Staff

Delivery Type

SIP – Self-Paced Online with Support

Duration & Delivery
  1. Course Duration: 3 weeks (80 hours)
  2. Format: Self-Paced Online with Support (narrated lessons, readings, quizzes, and role-based tasks).
Key Learning Objectives

   By completing this program, learners will:

  1. Understand the purpose and importance of TMF in clinical research.
  2. Learn the ICH-GCP E6(R2) guidance for essential documents.
  3. Explore the types of essential documents required before, during, and after a clinical trial.
  4. Gain knowledge of eTMF systems and indexing structures.
  5. Recognise how TMF supports audit and inspection readiness.
  6. Understand the roles and responsibilities of sponsors, CROs, and site staff in TMF management.
  7. Reviewbest practices for document maintenance, version control, and archiving.
Who Should Take This Course
  1. Clinical Research Associates (CRA) & CTAs managing site-level documents.
  2. Clinical Data Managers (CDMs) supporting inspection readiness.
  3. Quality & Compliance professionals preparing for audits/inspections.
  4. Regulatory staff ensuring adherence to ICH-GCP requirements.
  5. Career changers entering clinical research documentation roles.
Benefits & Outcomes
  1. Gain expertise in essential documents as per ICH-GCP E6(R2).
  2. Learn how to manage eTMF systems and reference models.
  3. Improve readiness for audits and regulatory inspections.
  4. Strengthen career opportunities in clinical operations, CDM, and compliance.
Career Pathways: After completing this course
  1. Clinical Trial Assistant (CTA)
  2. Clinical Research Associate (CRA)
  3. TMF Specialist / eTMF Coordinator
  4. Clinical Data Manager (CDM – Documentation Focus)
  5. Quality & Compliance Associate (GCP)

Curriculum & Modules

Modules
1. Introduction to Trial Master File (TMF)

2. ICH-GCP E6(R2) Overview – Essential Documents

3. Essential Documents Before the Clinical Trial (e.g., Protocol, Investigator Brochure, IRB Approvals)

4. Essential Documents During the Clinical Trial (e.g., CRFs, Monitoring Reports, SAE Reports, Communications)

5. Essential Documents After the Clinical Trial (e.g., Clinical Study Report, Final Closeout Documents)

6. eTMF Systems & Indexing Standards (DIA TMF Reference Model)

7. Document Quality, Version Control & Archiving Requirements

8. Common TMF Inspection Findings & CAPA Strategies

9. Case Studies – TMF Gaps and Regulatory Impact
Getting in Touch:

For more information, please call us at +1 732.770.4100 / +1 732.207.4564 (WhatsApp) or email qpdc@qtech-solutions.com. Our course specialists will reach out to you promptly to assist you in taking the next steps toward your career goals.