Regulatory Coordinator

Full course · Essential Records Infrastructure & Document Management

Active records management: maintaining the working file throughout the study — Essential Records Infrastructure & Document Management

Active records management: maintaining the working file throughout the study

Addresses the operational challenge of maintaining records currency during the busiest phase of the study lifecycle, across every active study in the portfolio.

20 min

The week everything arrives at once

Consider the following situation, which is not hypothetical. A site manages 14 active studies. It is the second week of January. Seven of those 14 studies have IRB continuing review deadlines falling within the next 60 days. Continuing review submissions generate records: the submission itself, the IRB acknowledgment, and -- once approved -- the continuing review approval letter. Simultaneously, two other studies have new protocol amendments working through the IRB approval process. Each amendment generates its own cascade of records: the amendment document, the IRB submission, the approval letter, the revised consent form, the consent form approval, and the updated version tracking entries.

In a single week, this site might receive 15 to 20 records requiring processing, filing, and -- for many of them -- cross-referencing and version control updates. The following week might produce five. The week after that, 25.

This is the operational reality of active records management. Records do not arrive at a predictable, constant rate. They arrive in surges driven by regulatory calendars, sponsor timelines, and the overlapping rhythms of studies at different stages. The regulatory coordinator who designs a records workflow for average volume will be overwhelmed during peak periods. The one who designs only for peak volume will build a system that is inefficient during normal operations.

This lesson addresses that design challenge. We are not teaching what documents to file during trial conduct -- that is single-study binder management, and the clinical research coordinator handles it. We are teaching how to design the portfolio-level workflow that ensures every record, across every active study, is processed and filed within defined timelines. Even during the weeks when everything arrives at once.

What you will learn3 objectives

By the end of this lesson, you will be able to:

Design an active records management workflow ensuring new records are processed and filed within defined timelines across all active studies, meeting the C.2.5 requirement for timely collection and filing
Apply the C.2.1 requirements -- identifiability, version control, authorship, and approval -- to the ongoing stream of records generated during trial conduct, establishing processing standards for each record category
Evaluate workload distribution for active records management across a multi-study portfolio, identifying peak periods and designing surge capacity procedures

Progress saves itself — finish reading and this lesson completes

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The week everything arrives at once