3 mistakes to avoid when planning your Trial Master File

The trial master file (TMF) needs to provide a complete story of how your trial was conducted and managed. As as quality and compliance manager, this can seem incredibly daunting as a mistake at the start of the process could result in the clinical trial being rejected. 

We've asked Dave Beard, Service Implementation Manager for Life Science customers at Qualsys to share three mistakes to avoid when planning how to manage your Trial Master File.  



1) Not planning for all the documents

A common mistake is that organisations believe the only documents they need to file are those listed in section 8 of International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) good clinical practice (GCP). 

The MHRA says:

This is incorrect and the documents listed in section 8 only provide half of the story, as a number of key areas are not included such as documentation associated with data management and Qualified Person (QP) certification. 

When you first start the process, it may seem like all the documents can be stored on a file on your desktop or in SharePoint. However, as the trial / trials evolve in complexity, scale and the volume of data to be processed explodes, you'll need a robust document management system. 

Qualsys provides an electronic trial master file documentation solution. When you implement the solution, our team will even work with you to establish an overarching document structure which will be scalable and effective. 

Doctor taking blood pressure of female patient at office

2) Poor record keeping 

Another issue is that businesses use multiple solutions to control documents. This means documents are poorly labelled and cannot be easily retrieved. 

The MHRA says: 

We have had to (on more than one occasion) add extra inspector days in order to complete the inspection due to problems with access to and provision of the TMF.  Problems with the provision of the TMF could result in the rejection of an application due to the inability to fully evaluate the compliance of the trial with GCP requirements.

eTMF Document Manager brings all your documentation into a single controllable framework. This means:

  • Any type of document can be controlled. The system is even compatible with CAD viewing technologies
  • Best practice record keeping by using our document control type fields 
  • Quick access, retrieval, updating and archiving


 Multiple Regulations - Filtered

3) Poor scoping of the eTMF

Many organisations acknowledge that they need an electronic system to manage their trial master file. However, this is not without its risks. 

The MHRA says: 

With the advent of new technologies there also comes the need to ensure that the systems function as required and can deliver additional benefits when compared to the systems that they replace.

Invest in a vendor who already has experience working with clinical trials. Consult an expert to scope your requirements.

For this, Qualsys provides a number of free services to help you build your VMP, eTMF strategy and a URS. 


Read our Good Clinical Practice software datasheet here


Read our case studies here

Gxp compliance software


Topics: FDA, ISO 17025, MHRA, GCP, GXP

Share your thoughts on this article