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The Post Coming July 1, 2023: New Regulatory Recordkeeping Requirement for Sponsor-Investigators at the U

Coming July 1, 2023: New Regulatory Recordkeeping Requirement for Sponsor-Investigators at the U

For a clinical trial, the adequate filing, storage, and maintenance of regulatory records is an essential process that demonstrates the compliance of the investigator and sponsor with local policy, state law, federal regulations, and GCP (Good Clinical Practice) standards. Regulatory records (commonly known as a regulatory binder, TMF (Trial Master File), or essential documents) must be maintained through all stages of a clinical investigation, and must be made available for review and inspection by designated monitors and applicable regulatory agencies (e.g. FDA).

The Clinical Research Support Office (CRSO), under the direction and authority of the Associate Dean for Clinical Research, has implemented the eReg platform as a University-wide electronic regulatory binder system. eReg is an online, 21 CFR Part 11-compliant system designed to house regulatory records and streamline the recordkeeping process. eReg has the ability to import documents from ERICA and interfaces with OnCore. eReg also allows remote, temporary access to be granted to external monitors or auditors.

All Investigator-Initiated Trials (IITs) where the Sponsor-Investigator (SI) holds an FDA Investigational New Drug (IND) or Investigational Device Exemption (IDE) application that receive initial IRB approval as of July 1, 2023 will be required to utilize eReg in lieu of a physical regulatory binder/TMF, or other online platforms (like Florence eBinders or Box).

Some essential documents, like a Delegation of Authority log or handwriting and signature samples, may still exist as primarily physical records. However, all essential documents should be uploaded and maintained in eReg.

Sponsor-Investigator IITs that received IRB approval prior to July 1st, 2023 will not be required to transition physical regulatory binders or other systems to eReg. Other clinical research being conducted at the University (non-interventional or observational IITs, network studies, industry-sponsored trials, etc.) are also not required to utilize eReg at this time. Requirements for these studies will be announced at a later date. Study teams with industry trials are encouraged to switch to eReg in advance of the requirement, in part to facilitate fully-remote monitoring visits with EPIC Link functionality.

To begin utilizing eReg, training and orientation must be conducted with the CRSO training team, in addition to Advarra University modules. If your team or department has not already been contacted to schedule a training session, please contact us. For other questions or to schedule individual training, please visit this site. Additional training resources and guides are also available on our website.

For questions regarding this requirement or its implementation, please contact the CRSO Quality Assurance (QA) team.