Trial Master File

Identifying Missing Documents: Study-Specific Plans

Post by
Denise Lacey
Identifying Missing Documents:  Study-Specific Plans

The last blog post presented the problem of identifying missing documents and the solution of QCing a Trial Master File like you would clean a database, by means of cross-checks. Today we'll look at some useful cross-checks for identifying missing study-specific plans. These are the plans that are found mostly in section 01.01 of the TMF Reference Model, but it also includes other plans scattered throughout the structure, to wit:

  • 01.01.01 Trial Master File Plan
  • 01.01.02 Trial Management Plan
  • 01.01.03 Quality Plan
  • 01.01.05 Operational Procedural Manual
  • 01.01.06 Recruitment Plan
  • 01.01.07 Communication Plan
  • 01.01.08 Monitoring Plan
  • 01.01.16 Risk Management Plan
  • 01.01.17 Vendor Management Plan
  • 06.01.01 IP Supply Plan
  • 07.01.01 Safety Management Plan
  • 10.01.01 Data Management Plan
  • 11.01.01 Statistical Analysis Plan
  • 11.02.01 Randomization Plan

The easiest way to perform this check is to use a plan tracker, which is maintained throughout the study and stored in section 01.05.02, Tracking Information. If that tracker doesn't exist, here are some other places to start.

  • Search the sponsor's or CRO's SOPs for the word "plan." Make a list of all the plan types required per SOP and then search the sections above to determine if they're filed. If not, search other sections of the TMF to determine if they're misfiled.
  • Skim all the plans filed in the sections above to determine if other study-specific plans are referenced. If there is a general Project Management Plan stored in 01.01.05, start there.

Now that you have a list of the plan types that should be there, search the TMF sections listed above and do the following:

  • List each plan with version and date (ideally, via a report from your electronic TMF). Look for gaps in version numbers.
  • Review the version history for the last version of each plan. Look for versions listed that are not in the TMF.
  • Compare the dates of the plans with the start and end dates of the study. Ask the study team about any unexpected gaps in time.

The speed of this activity depends upon whether your eTMF is structured to generate usable reports, with consistent document naming conventions, version numbers, and document dates. If it's not - and a surprising number of eTMFs we audit don't meet this criterion - then every document must be opened in order to create a manual list.

Now that you've generated a list of potential gaps, you can search for specific documents, version numbers, and date ranges, starting with a general search for misfiled documents, and then expanding to that treasure trove of "documents attached to emails."