Professional Learning Track

Regulatory Affairs

Regulatory requirements, submissions, and compliance for clinical trials

Invitation Only

This track requires an invitation code to enroll.

Track Curriculum

1 course in this track

Complete these courses in order to earn your track certificate.

1

Essential Documents and the Trial Master File

View Course Details

8 modules

Designed For

Regulatory Affairs SpecialistRegulatory CoordinatorClinical Operations ManagerQuality Assurance Specialist

Have an invitation code?

Enter your invitation code to enroll and start learning. Complete all courses in this track to earn your verified certificate of completion.

Professional Learning Track

Regulatory Affairs

Regulatory requirements, submissions, and compliance for clinical trials

Invitation Only

This track requires an invitation code to enroll.

Track Curriculum

1 course in this track

Complete these courses in order to earn your track certificate.

1

Essential Documents and the Trial Master File

View Course Details

8 modules

Designed For

Regulatory Affairs SpecialistRegulatory CoordinatorClinical Operations ManagerQuality Assurance Specialist

Have an invitation code?

Enter your invitation code to enroll and start learning. Complete all courses in this track to earn your verified certificate of completion.

32 lessons

1

The Foundation: Why Essential Documents Matter

1The regulatory basis for essential documents
2Purpose and function of trial documentation
3Stakeholder responsibilities for documentation
4Introduction to the Trial Master File
Module Quiz10 questions

2

Before the Trial: Pre-Study Essential Documents

1Regulatory submissions and approvals
2IRB/IEC documentation requirements
3Investigator and site qualification documents
4Protocol and investigational product documentation

3

During the Trial: Ongoing Documentation Requirements

1Protocol amendments and document updates
2Safety reporting documentation
3Monitoring visits and oversight documentation
4Ongoing regulatory and IRB communications

4

After the Trial: Close-Out, Retention, and Archival

1Trial close-out documentation
2Clinical study reports and final analyses
3Document retention requirements
4Archival procedures and long-term access

5

The DIA TMF Reference Model

1Understanding the DIA TMF Reference Model
2Zones, sections, and artifacts
3Artifact attributes and metadata
4Customizing the Reference Model for your organization

6

Electronic TMF Systems in Practice

1Electronic TMF fundamentals
2Daily eTMF operations
3eTMF quality review processes
4Managing the paper to electronic transition

7

TMF Quality and Health Metrics

1Dimensions of TMF quality
2Completeness and expectation management
3Timeliness standards and filing targets
4TMF health dashboards and remediation

8

Inspection Readiness and Common Deficiencies

1The inspector perspective on TMF review
2Common TMF deficiencies and their causes
3Prevention strategies and best practices
4Preparing for and supporting inspections

Essential Documents and TMF Final Exam60 questions · 75 min · 80% to pass · 3 attempts