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Next on our TMF QC list: Committees, Section 01.03 in the TMF Reference Model. This section is fairly straightforward, but it usually generates a number of issues.
A study may have independent committees, such as a Data Monitoring Committee or Endpoint Adjudication Committee, who contribute CVs, financial disclosure forms, contracts, and confidentiality agreements for filing in this section. There also may be internal bodies that style themselves as "committees," such as a meeting of investigators called the Dose Escalation Committee, or a pharmacovigilance-led meeting called the Safety Committee; these committees may be filed here or in another "meetings" section, and CVs, financial disclosures, contracts, and confidentiality agreements are typically not collected for these members. Review the protocol and project management plans to get a full list of committees, and check the TMF index to verify which sections are intended to hold which committee documents.
For each independent committee, verify that all charters have been filed in 01.03.01, checking the version histories and gaps in version numbers for missing versions. Read through each charter to generate a list of expected meetings and timing. Sometimes, committee member rosters are included in the charter; if not, look for a separate roster in 01.03.02. Review each member list to compile a complete history of members with their start and stop dates, if there were changes.
Verify that all expected meeting documents are in 01.03.03. These typically include agendas, minutes, and review materials; the charter may also indicate that for some meetings, recommendation forms are generated.
For each person on your committee member history, verify that a CV is on file in 01.03.04. CVs are typically signed and dated to indicate whether they are current. Confirm that a financial disclosure form is filed in 01.03.05; this should be dated prior to the committee member's participation. Verify that a contract is on file in 01.03.06 and a confidentiality agreement in 01.03.07, also dated prior to participation. If contracts and confidentiality agreements are not filed, check the TMF index to see if they are held in a different repository, and follow up with that repository owner to verify that all expected documents are present.
If a privacy agreement has been collected, verify that it is present for all members.
For internal committees, locate the section in which the relevant meeting materials are filed and check for agendas and minutes for each meeting. For long studies, Excel is a terrific help: export the document metadata and sort by date, looking for gaps that indicate missing agendas, minutes, or materials.
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.