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Clinical Research

Updated October 13, 2011

NIAMS Policies, Guidelines and Sample Documents for Clinical Trials

As part of its mandate, the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) supports numerous clinical research activities. Research that involves human subjects requires the NIH to focus on the protection of human subjects and study integrity. Therefore, the NIAMS has developed guidance documents to assist Investigators with meeting the required NIH, Institute and other Federal requirements for safe, ethical, and high quality clinical research. Information on the application submission process, planning grant requirements, writing a data and safety monitoring plan, composing a MOOP, understanding Investigator responsibilities, and sample documents and templates to get you started are found here.

For more information or questions, contact a NIAMS Clinical Coordinator.

Table of Contents

NIAMS Policy: Conversion of a Grant to a Cooperative Agreement
Data and Safety Monitoring Guidelines and Policies
Guidelines for Developing Clinical Study Documents and Sample Templates

NIAMS Policy: Conversion of a Grant to a Cooperative Agreement

Data and Safety Monitoring Guidelines and Policies

  • NIH Policy Concerning Data and Safety Monitoring (released on June 10, 1998)
  • Further Guidance on Data and Safety Monitoring for Phase I and II Trials (released on June 5, 2000)
  • NIAMS Data and Safety Monitoring Guidelines

    This document summarizes the NIAMS guidelines for data and safety monitoring (DSM) activities. The DSM plan may vary from a safety officer to a committee, also known as a data and safety monitoring board (DSMB).

  • Guidelines for Developing a Monitoring Plan for Clinical Studies Sponsored by NIAMS

    The purpose of this document is to provide a guide for developing a data and safety monitoring plan. It outlines the type of monitoring body (e.g. DSMB, OSMB or Safety Officer); responsibilities of study staff and monitoring body; procedures for data review and reporting for adverse events; and contents and format of the safety reports.

    • NIAMS requires that each trial it supports, regardless of phase, have data and safety monitoring procedures in place to safeguard the well-being of study participants and to ensure the trial's scientific integrity. As an aid in preparing the budget section of the PI's grant application, this document provides guidelines for budgeting for these activities.

  • Principal Investigator Responsibilities Related to NIAMS-appointed Data and Safety Monitoring Boards

    This document describes the roles of the clinical study Principal Investigator with respect to a Data and Safety Monitoring Board (DSMB). The role of the DSMB is to provide ongoing, independent study review and assure the study is conducted according to the highest scientific and ethical standards.

  • Principal Investigator Responsibilities Related to a NIAMS-appointed Independent Safety Officer

    For small, single-site clinical trials with low risk, NIAMS may decide that an independent Safety Officer can provide data and safety monitoring (rather than a Data and Safety Monitoring Board). This document outlines the requirements for reporting to a Safety Officer, as well as the Safety Officer's role and responsibilities.

Guidelines for Developing Clinical Study Documents and Sample Templates