In Worldwide Clinical Trials we are focused to have the TMF Inspection ready at all times.

In order to achieve this, we are creating, monitoring and reporting on the 7 TMF KPIs that are related to Timelines, Quality and Completeness:

·       Submission Timeliness – % of documents submitted within the timelines agreed in the TMF Management Plan

·       Approval Timeliness - % of documents approved within the timelines agreed in the TMF Management Plan

·       Submission Quality - % of documents submitted without errors

·       Query Response Timeliness - % of queries responded within the timelines agreed in the TMF Management Plan

·       Risk Score – Risk impact of missing/queried documents per different document types

·       Completeness by Milestone - % of present documents vs. expected documents in accordance with the applicable milestone

·       Completeness by Milestone Provisional – progress in the completeness for the applicable milestone

-        Explore the moral and ethical standards most commonly missed that can be identified through an effective audit

-        How data integrity differs in an internal to external context, and gauge what steps can be taken to ensure vendors deliver at a required standard

-        Realise how the validation process is crucial to audits by understanding what processes are under your responsibility, whether these standards match with your chosen vendors, all whilst in-keeping with required regulatory standards.

-        Look at processes on sites, documentation is there, information is included, document can be easily located

-        What can you do as a person or group to ensure the integrity of data. Learn how to manage these steps with a risk-based approach