e-IRB India is a comprehensive web-based platform that provides a complete electronic solution for the paperless management of Institutional Review Board (IRB) documentation and related activities. The system streamlines the ethical review process by digitizing submissions, reviews, approvals, and communication while ensuring secure and efficient workflow management. It also offers a long-term electronic archival facility for IRB records in compliance with applicable regulatory requirements, ensuring secure storage, easy retrieval, and regulatory compliance throughout the record retention period.
- It provides web-based software services like :
- Electronic registration and secure login ID creation for Institutional Review Boards (IRBs), Sponsors, Clinical Research Organizations (CROs), and Hospital Sites/Investigators.
- Online submission and management of clinical trial applications, including protocols, protocol amendments, and other study-related documents for IRB review and approval.
- Generation and management of IRB records including Meeting Agendas, Minutes of Meeting (MoM), Approval Letters, and other documents.
- Online notification and tracking of study progress reports, study updates, study schedules, Serious Adverse Events (SAE) , and Protocol Deviations.
IMPORTANT NOTE: This portal is designed to efficiently manage documentation pertaining to the day-to-day operations of Ethics Committees. While it facilitates documentation, communication and archival, all decisions must be made by the respective Ethics Committees in strict compliance with applicable regulations, guidelines and standard operating procedures (SOPs). As per Indian Good Clinical Practice (GCP),“The ethical review should be done through formal meetings and should not resort to decisions through circulation of proposals.”
- The functioning of Ethics Committees must remain compliant with:
- New Drugs & Clinical Trials Rules – 2019
- Indian Good Clinical Practice (CDSCO)
- National Ethical Guidelines for Biomedical and Health Research Involving Human Participants (ICMR)
- Respective Ethics Committee SOPs
The e-IRB India is a complete web-based service for providing electronic solution for paperless documentation of Institutional Review Board (IRB) and its related activities. It also provides long term e-archival facility for IRB records as per regulatory agency requirements.