A Conceptual Workflow for Functional Quality Control Sign-Off in Clinical Trial Master Files
Abstract: The trial master file (TMF) is the organized collection of essential records used to assess trial conduct and the reliability of trial results. Functional quality control (FQC) reviews can identify missing, incomplete, or inconsistent records, yet review documentation and sign-off may be distributed across separate forms and system workflows. This paper presents a conceptual workflow and de-identified form mock-up for recording functional review completion through an electronic-signature platform and filing the resulting record in an electronic TMF (eTMF). A document-based design approach was used: a sponsor-provided FQC form was examined at the field level, public guidance on TMF management and electronic records was reviewed, and requirements were translated into a workflow and proposed form structure. The design captures review scope, dates, method, findings, reviewer attestations, signature meaning and timestamp, and final eTMF filing and approval references. No implementation, participant data, or measured effectiveness results are reported. A prospective evaluation is proposed using cycle time, on-time completion, signature completeness, rework, and user feedback. The mock-up is a conceptual design and requires sponsor quality, records-management, privacy, and system-validation review before operational use.
Keywords: trial master file; functional quality control; electronic signature; eTMF; process design
How to Cite?: Jyoti (Jo) Agarwal, Satyakam Singh, "A Conceptual Workflow for Functional Quality Control Sign-Off in Clinical Trial Master Files", Volume 13 Issue 2, February 2024, International Journal of Science and Research (IJSR), Pages: 1936-1940, https://www.ijsr.net/getabstract.php?paperid=SR240229113246, DOI: https://dx.doi.org/10.21275/SR240229113246