Process for application of ethical clearance and conducting research in CIHSR, Dimapur Step 1: The requirements and guidelines for formation of the ethics committee and the process of ethical clearance are regulated by the ‘New Drugs and Clinical Trials Rules 2019’ under Drugs and Cosmetic Act, 1940. Go through...
(adapted from 2017 National Ethical guidelines for Biomedical and Health research involving human participants, ICMR) The context of health research using social and behavioral sciences methods is often different from typical clinical, biomedical and public health research. Many of these research initiatives are relevant in the mid to long term...
14.1 Purpose: The purpose of this SOP is to detail how the IRB manages any premature termination/ suspension/ discontinuation of a research study. Protocols are usually terminated at the recommendation of the IRB, PI, sponsor or other authorized bodies wherein subject enrolment and study follow-up are discontinued before the scheduled...
12.1 Purpose To outline the procedures for documenting the IRB activities. 12.2 Scope This SOP will apply to all biomedical and health research activities done through IRB CIHSR, without regard to the source of funding. 12.3 Responsibility It is the responsibility of IRB Secretary to maintain IRB files at IRB...
11.1 Definition of terms Active Project file: refers to file pertaining to an ongoing study Completed file: refers to file pertaining to a completed study Master file: refers to file comprising of all essential documents and correspondence related to the study/protocol. 11.2 Purpose To provide guidelines for preparation and maintenance...
10.1 Purpose The purpose of this SOP is to provide instructions on the review and follow-up reports of serious adverse events (SAEs), expected adverse events (AE) and unexpected events for any active study approved by the IRB. The SAE must be reported by the investigators to the IRB within 24...
9.1 Purpose This section provides the managements which includes taking action and maintaining records, when investigators/ trial sites, fail to – Follow the procedures written in the approved protocol Comply with national / international guidelines for the conduct of biomedical research, including those who fail to respond to the IRB...
8.1 Purpose: The purpose of continuing review is to: Monitor the progress of the research study which was previously approved by the IRB, To ensure the continued protection of the rights and welfare of the research participants. Continuing review of the study may not be conducted through an expedited review...
7.1 Purpose: This describes how protocols, documents and letters are amended and reviewed by the IRB. 7.2 Scope: This SOP relates to review of amended study protocol / documents and letters that are submitted for IRB approval. Amendments made to study protocols, documents and letters related to the study may...
6.1 Purpose The purpose of this procedure is to elaborate administrative process and provide instructions for preparation, review, approval, and distribution of meeting agenda, minutes, and notification letters of IRB, CIHSR meetings. 6.2 General meeting of IRB The day, time, and venue of IRB meetings are specified as follows: SC-IRB...
