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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:
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.
Now that you have a list of the plan types that should be there, search the TMF sections listed above and do the following:
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."
Denise DeRenzo Lacey, RQAP-GCP, has over twenty years’ experience in clinical Quality Assurance and clinical development operations. Her practice focuses on application of quality risk management techniques for clinical studies, including risk-based approaches to auditing, data quality and integrity, and SOP development. She has provided consulting services to a wide range of pharmaceutical, medical device, biotech and CRO clients in the US and Europe and has held senior positions at Vertex Pharmaceuticals and Radius Health.