TMF Reference Model Opens 2017 Survey

February 23, 2017
TMF Reference Model

The TMF Reference Model has released a survey for industry professionals designed to provide insight for both paper and electronic trial document management.

Revision 2 of ICH GCP E6 includes new detail on GCP Essential Documents in Section 8, and Trial Master Files (TMF) are in the spotlight now more than ever. All stakeholders – sites, inspectors, sponsors, CROs, and vendors - are welcome to take the TMF Reference Model's state-of-the-industry 2017 TMF Survey, designed to provide insights for both paper and electronic trial document management. This is the only non-commercial TMF survey conducted by and for the stakeholder community; survey results are shared with every participant.

Key objectives of the survey include:

  • Identifying trial document management trends

  • Assessing changes in industry directions

  • Measuring the impact of TMF practices

The TMF Survey has been conducted since 2012, with the design continually refined for the changing landscape. Jane Twitchen of Biogen, survey team leader, says "this year, we’re keen to understand who our sponsor contributors are; for example, do sponsors from Diagnostics or Device organizations now have an increased representation in the TMF Reference Model initiative? We would also like to understand more regarding Inspection experiences and specifically Inspector Access."

Fran Ross of Paragon Solutions, the TMF Reference Model Steering Committee liaison to the survey team, has been involved since the survey's inception, and pointed out some key learnings from last year's results:

  • 29% manage all paper documents for inspection, while 11% report all electronic inspections

  • A wide variance in the number of document types that require signature: from more than 100 separate types to less than 10

  • Only 4% of respondents are destroying paper after scanning, while 46% are maintaining every scanned page

The results of last year's survey (and all previous years) are available on the TMF Reference Model's Resource Page.

The TMF Reference Model encourages all stakeholders, including regulators, sponsors, CROs, sites, vendors and consultants to take the survey! Survey results are distributed to all participants, and are targeted for release before this year's DIA Annual Meeting.

The TMF Survey is developed by volunteer members of the TMF Reference Model initiative; more information is available at the end of the survey and can also be found at http://tmfrefmodel.com.