from the link I provided; This guidance discuss

from the link I provided;

This guidance discusses the roles, responsibilities and operating procedures of Data Monitoring
Committees (DMCs) (also known as Data and Safety Monitoring Boards (DSMBs) or Data and
Safety Monitoring Committees (DSMCs)) that may carry out important aspects of clinical trial
monitoring. This guidance is intended to assist clinical trial sponsors in determining when a
DMC may be useful for study monitoring, and how such committees should operate. We
recognize that in many clinical trials the sponsor delegates some decision-making regarding the
design and conduct of the trial to some other entity such as a steering committee (see Section
3.2) or contract research organization (CRO) (see 21 Code of Federal Regulations (CFR)
312.3(b)). This document, while pertaining primarily to the sponsor with regard to trial
management and decision-making, may also be relevant to any individual or group to whom the
sponsor has delegated applicable management responsibilities (see Section 3). This guidance
finalizes the draft guidance entitled "Guidance for Clinical Trial Sponsors: On the Establishment
and Operation of Clinical Trial Data Monitoring Committees" dated November 2001.