The New Trial Master File Industry Survey

May 12, 2014

  • eTMF Guidelines

The TMF Reference Model initiative just announced the release of the fourth industry-wide Trial Master File Survey.  This survey has provided great value to the industry in the past as it helps us to understand the rate of technology adoption and reference model adoption, as well as related issues and obstacles. 

Although asking the same questions every year helps us to identify and measure trends and to assess progress, we also added some new questions this year (and retired a few old questions).  Specifically, we added:

  • Special questions for regulators designed to provide insight on issues around eTMF inspections and whether the adoption of the reference model by sponsors and CROs helps to streamline inspections
  • organizations who have not adopted the reference model, questions designed to explore why the model has not been adopted
  • (My own personal favorite) questions about whether organizations have put metrics programs in place, and if so what they are measuring

We also redesigned the survey to avoid asking vendors and consultants questions that are not relevant to the roles they play on TMF projects.  By doing this we feel that results will be more accurate as it’s often not clear to them if they should be responding on behalf of their clients or with some other perspective. 

Make sure your perspective is heard, and get valuable insights and data for your TMF improvement initiatives.  Click here to access the survey.  Survey completion takes ten minutes or less, depending on your organization.  All respondents who complete the survey and provide contact details will be sent the results; no individual is identified in the results. 

The TMF Survey is developed by volunteer members of the TMF Reference Model initiative. Information about us is found at the end of the survey, and also at:  http://www.diahome.org/en/news-and-publications/publications-and-research/edm-corner.aspx