OnCore serves as the Clinical Trial Management System, facilitating clinical research operations at Johns Hopkins Medicine. This online platform enables thorough management of clinical research studies, offers robust reporting capabilities, facilitates enrollment tracking, and ensures accurate clinical research billing.

All studies with a prospective reimbursement analysis (PRA) will require the use of OnCore. For studies without a PRA, the use of OnCore is optional.

On September 26th, Johns Hopkins Medicine (JHM) launched the eRegulatory Management System (eReg) for a select group of pilot users and protocols. The platform will be available system-wide in March 2025. eReg is an electronic regulatory binder integrated with OnCore, enabling study teams to efficiently manage study documents. Importantly, eReg complies with 21 CFR Part 11 standards, ensuring data integrity and security.

According to the Draft eReg Use Policy, the following studies will require the use of eReg:

• All new studies conducted under an FDA IND/IDE (all Sponsors) and all new prospective clinical studies meeting the ClinicalTrials.gov definition of an Interventional Study, initially submitted to an Institutional Review Board (IRB) on or after January 1, 2025.
• All clinical studies where a JHU faculty member serves as the Sponsor-Investigator of an Investigational New Drug (IND) or Investigational Device Exemption (IDE). Regulatory documents and submissions completed on or after June 1, 2022, must be uploaded to eReg.

For existing studies under an IND/IDE for which the JHU faculty member does not serve as the Sponsor-Investigator, submitted to the IRB before January 1, 2025, as well as non-interventional, FDA-exempt studies, such as observational studies, the use of eReg is optional.