Regulatory Coordinator

Full course · Essential Records Infrastructure & Document Management

The essentiality determination: applying the framework to decide what must be retained — Essential Records Infrastructure & Document Management

The essentiality determination: applying the framework to decide what must be retained

Teaches the RC to apply ICH E6(R3) Appendix C, Section C.3 criteria as the analytical framework governing what the site's records infrastructure must accommodate.

22 min

When the sponsor asks you to retain something that is not on the list

A sponsor's clinical monitoring plan arrives at the site. Buried in Section 12 -- records retention requirements -- is a line the regulatory coordinator has not encountered before: "The site shall retain all centralized monitoring reports and related queries for the duration of the retention period." The RC checks the Essential Records Table in ICH E6(R3) Appendix C. Centralized monitoring reports are listed. But the related queries -- the specific data clarification requests generated by statistical signal detection algorithms and sent to the site for resolution -- are not listed as a separate line item.

The sponsor expects retention. The table does not explicitly list the item. And the RC must make a determination: is this record essential?

This is not a hypothetical dilemma. It is the kind of question that arises routinely at any site running more than a handful of studies, because no list -- however comprehensive -- can anticipate every record that every trial design will generate. ICH E6(R3) anticipated this problem. That is why Appendix C, Section C.3 provides not just a table of essential records, but a set of criteria for determining essentiality. The table is the product of those criteria. The criteria are the tool.

This lesson teaches you to use that tool. Not as a memorization exercise -- nobody benefits from reciting 28 lettered criteria -- but as an analytical framework that governs what your site's records infrastructure must be designed to accommodate.

What you will learn3 objectives

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

Apply the essentiality criteria in ICH E6(R3) Appendix C, C.3.1 (items a--bb) to evaluate whether specific records must be retained
Analyze how the Essential Records Table (C.3.2--C.3.3) interacts with the essentiality criteria to create a determination framework
Evaluate situations where records not in the Essential Records Table may nonetheless qualify as essential

Progress saves itself — finish reading and this lesson completes

Continue with the Regulatory Coordinator track

When the sponsor asks you to retain something that is not on the list