Organize Your Study: Study & Subject Binders
Complete and thorough protocol documentation generally includes a Study Regulatory Binder, in which all study related documents and correspondence are stored, and individual Subject Case Histories, in which subject specific documents are maintained.
Developing and Maintaining the Study Regulatory Binder
The purpose of the regulatory binder is to store and organize required or useful study documents and correspondence. An up-to-date regulatory binder facilitates the effective and efficient management of studies and may decrease procedural errors. An organized regulatory binder may also maintain continuity in the event of staff changes.
Study Regulatory Binders are not required, but are considered best practice and highly recommended. While the entire research team should be familiar with the regulatory binder, one (or two) person should be designated to maintain and update the binder.
The designated person should be listed as the additional contact (w/ the CCI) for the study to ensure all CCI/IRB correspondence and documents are received in a timely manner. The binder should be maintained in a safe and locked location, though easily accessible to all research staff at all times.
The following documents are included in EQuIP's template regulatory binder:
Regulatory Binder Instructions
Table of Contents
Contact and Resources
The Harvard CATALYST also developed a template regulatory binder and accompanying guidance that are available to all researchers.
Subject Case Histories
Individual subject information should be maintained separately from the regulatory binder in subject specific binders or folders. Subject case histories generally include signed informed consent forms, source documents and completed case report forms.
Source documents are the hard copies on which clinical observations are first recorded. Source documentation is often the medical record, but it can also be a computer printout of lab values, patient diaries, physician progress notes, etc. Case report forms (CRFs) are the research instruments designed to collect the variables that are necessary to answer the research questions of a specific protocol.
The following document provides guidance on how to create, manage and update complete individual subject case histories. Please be sure to review the Study Visit Documentation guidance and templates, located on the Tools and Templates page, for additional information and guidance on maintaining complete subject case histories.