NIH Research Festival
The ICH GCP Guidelines define Essential Documents as those documents which individually and collectively permit evaluation of the conduct of a trial and the quality of data produced. Maintaining all these documents over the lifespan of a trial can be voluminous. It is in the best interest of the study team at keeping the binder accurate and current for review by sponsor’s CRA during site visits, institutional auditor review and or any regulatory authorities visiting for audit purpose. NIAID Office of Clinical Research Policy and Regulatory Operations (OCRPRO) in collaboration with NIAID Business Process and Information Management Branch (BPIMB) developed and provided to the NIAID DIR Clinical Teams an Electronic Regulatory Binder (eReg Binder), a paperless process of maintain essential documents. The eReg Binder uses EDRMS (Electronic Document and Records Management System) as the platform. The advantages to eReg Binder is that it is more efficient and cost effective; allows real-time availability of documents by the CRA and institutional personnel needing access to documents; has search capability and quick view access of documents stored; and archiving at the end of the trial. With the use of Protocol eReg Binder Folder Templates a protocol folder can be set up and ready for use within minutes. EDRMS has drag and drop features so documents can be added quickly or has the ability to add links such as website for CC Pathology Normal Ranges. Currently nine DIR clinical laboratories are using the system and close to 100 protocol eReg Binders are being maintained.
Scientific Focus Area: Research Support Services
This page was last updated on Friday, March 26, 2021