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.
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.