Regulatory Documentation in Clinical Trials

A clinical trial is only as good as the records kept by investigators and their research teams. Research sponsors tend to be very specific in outlining their expectations for records kept by participating sites; regulatory bodies leave more room for interpretation as to the methods of data collection and documentation. Where investigator responsibilities are not explicit in regulations or guidance documents, they are frequently implied as a means of demonstrating compliance with other requirements.

The ICH E6 Guideline for Good Clinical Practice provides a comprehensive list of documents that are essential to the conduct of a clinical trial. Broadly, these include:

  • Investigational product documentation and records
  • The protocol
  • Data collection instruments
  • Consent forms and any other written materials intended for participants
  • Advertisements/recruitment materials
  • Financial and legal agreements pertaining to the trial
  • IRB correspondence and documentation
  • Regulatory correspondence and documentation
  • CVs, licenses, certifications, training records and other relevant documentation for trial personnel
  • Laboratory and equipment documentation
  • Blinding and randomization procedures
  • Monitoring reports, audit reports and other relevant trial correspondence
  • Source documents
  • Adverse event reports and other safety-related communications
  • Administrative logs

This list is intended to apply to trials of investigational drugs, biologics and devices, but it can be used as a guide in setting up regulatory files for other types of clinical research. Not all items on the list will be appropriate for every trial, or for every site file. For multicenter trials, some items will be kept in the sponsor or coordinating center’s files. Each investigator should still understand who is responsible for maintaining those records and how to access information needed to ensure compliance and participant safety.

InfoEd’s Clinical Trials module facilitates the storage and organization of regulatory documents within each trial record, through which they can be shared with all members of the research team (and others where appropriate). The Regulatory Compliance tab is one aspect of regulatory document management. The setups currently available for this tab are limited, which poses some challenges in light of varying business processes and terminology. Possible improvements include capability to repurpose and make additions to the basic folder set; many-to-one document type mapping; and tighter control of access to uploaded documents as well as eForms based on mapping and security setups. The goal of these improvements will be to eliminate the need for a separate regulatory binder, or at least make it possible to limit the documentation stored offline to items that still require a paper process. Please contact InfoEd Support with any questions or suggestions.

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