STEPS TO STUDY ACTIVATION
Explore eRegulatory and eConsent Options
eRegulatory
The Advarra eRegulatory platform is our institution’s choice for an electronic regulatory system. This system can take the place of the standard paper regulatory binder. This system is available to IU/IUH researchers. Studies that are managed in OnCore are eligible for eRegulatory implementation.
The Advarra eRegulatory system offers the following benefits:
- Improve your routing and workflows: Quickly and easily route documents, automatically alert staff when new documents are available, and boost regulatory compliance and efficiency with 21 CFR Part 11 compliant electronic signatures for protocol documents, delegation of authority, and more.
- Avoid the burden of paper binders: Save time, space, and internal resources by utilizing a system designed to efficiently upload, search, and update documents electronically.
- Apply shared documents and records across multiple protocols: Create standard templates for protocol-essential documents tailored to each study type (NIH, Industry, etc.) that can be used repeatedly, and share staff credentials across multiple protocols.
- Support master delegation of authority processes: Allow us to standardize delegated tasks at the system level, dramatically reducing the amount of time spent routing documents.
- Efficiently and compliantly manage multi-site trials: As a coordinating center, view and manage protocol documents for participating sites in an investigator-initiated trial.
eConsent
Advarra eConsent is a 21 CFR Part 11 compliant module that is part of the Advarra eRegulatory system. It allows you to electronically route and sign consents for clinical research studies. It is recommended for any FDA-regulated study wishing to consent participants electronically but can be used for any study desiring to consent electronically.
For non-FDA regulated research (that does not involve drug, device, or biologic), the REDCap database can be set up to obtain remote, electronic consents. This option is not validated for FDA Part 11 compliance, so it should not be used for studies of FDA-regulated products. See more at Build Out Study Database.
For more detailed information about eConsent and eRegulatory options, or to request access please refer to the OCR website or contact oncore@iu.edu.
IU Simon Comprehensive Cancer Center (IUSCCC) Additional Information
For Cancer Center Trials (studies involving cancer patients):
For studies involving the Cancer Center’s Adult Clinical Trials Office (CTO), managing regulatory documents through eReg is required as of January 1st, 2025. For more information, please reach out to Vanessa Williams at vanewill@iu.edu.
Exploring eRegulatory and eConsent options is only one component of study activation. Additional requirements should be reviewed using the Clinical Research Roadmap.