Module 12 2019

How is a TMF Organised

Zone

Section

Artifacts

1.

Trial Management

Each Section is further defined into artifacts

Each zone contains specific sections that are standard by the industry

2.

Central Trial Documents

These documents can be defined specific to the company processes

3.

Regulatory

Generalized topics

4.

IRB/IEC and other Approvals

5.

Site Management

Documents can be blinded or unblinded

6.

IP and Trial Supplies

7.

Safety Reporting

Core TMF documents are required per industry standard

8.

Centralized Testing

Recommended TMF documents are suggested per the industry

9.

Third Parties

10.

Data Management

11.

Statistics

DIA TMF reference model v.3

The Organisation for Professionals in Regulatory Affairs