Regulatory Coordinator
Full course · Essential Records Infrastructure & Document Management
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Teaches the RC to design filing taxonomies and naming conventions that survive staff turnover, accommodate sponsor-specific requirements, and remain intuitive to anyone who needs to locate a record.
A coordinator at a busy research site managed nine active clinical trials for just over six years. She was, by every measure, excellent at her job. During monitoring visits, she produced requested documents within minutes. She knew where everything was -- every protocol amendment, every IRB approval letter, every signed consent form, every safety report across all nine studies. Her principal investigators trusted her completely, and her monitors praised the site's efficiency.
Then she accepted a position at another institution.
Her replacement arrived to find nine studies with nine different organizational structures, each reflecting the departing coordinator's evolving filing preferences over six years. Study folders on the shared drive had names like "CARDIO_stuff_FINAL," "IRB_misc_2024," and "Protocol_NEW_v2_REAL." Physical binder tabs were labeled in shorthand that made sense to someone who had spent six years with those studies but communicated nothing to a newcomer. The replacement coordinator, who was competent and well-trained, could not locate a requested IRB approval letter across three studies during her first monitoring visit. Not because the letters did not exist. Because the filing system was not a system. It was one person's mental map, externalized inconsistently across binders and folders, and it left with the person who created it.
This scenario is not unusual. I have seen some version of it at nearly every site I have visited, and it reveals a fundamental design failure that no amount of individual competence can overcome. The departing coordinator did not fail. The site failed to build infrastructure that transcended any individual. That infrastructure is a filing taxonomy paired with naming conventions -- the subject of this lesson.
What you will learn3 objectives
By the end of this lesson, you will be able to:
Progress saves itself — finish reading and this lesson completes
