Clinical Research

Updated June 24, 2014

NIAMS Policies, Guidelines and Sample Templates 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 help Investigators meet 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 Manual of Operations and Procedures (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

Data and Safety Monitoring Guidelines and Policies

Guidelines for Developing Clinical Study Documents and Sample Templates

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 activities for data and safety monitoring (DSM). The DSM body may be comprised of an independent safety officer or a committee, also known as a data and safety monitoring board (DSMB).

  • Guide for Developing a Data and Safety Monitoring Plan for Clinical Studies Funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (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.

  • 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.

  • The National Institute of Arthritis and Musculoskeletal and Skin Diseases Guidelines for Reporting to a 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

  • Guidelines for Developing a Multi-site Manual of Operating Procedures (MOOP)

    The purpose of this document is to help investigators prepare a study Manual of Operating Procedures (MOOP) for multi-site studies by providing them with a MOOP template. When clinical studies are conducted at multiple clinical centers, a study MOOP is developed to facilitate consistency in protocol implementation and data collection across staff, patients and clinical sites.

  • Guidelines for Developing a Single-site Manual of Operating Procedures (MOOP)

    The purpose of this document is to help investigators prepare a study Manual of Operating Procedures (MOOP) for single-site studies by providing them with a MOOP template. When clinical studies are conducted at a single center, a study MOOP is developed to facilitate consistency in protocol implementation and data collection across staff.

  • Report Templates for Studies with Data and Safety Monitoring Oversight

    The purpose of these templates is to act as guidance and a reference document for investigators, study staff, data managers, study statisticians and others involved in submitting periodic reports to NIAMS-appointed, independent monitoring bodies (e.g., an independent Data and Safety Monitoring Board or Safety Officer) for either multi-site or single-site studies. The proposed structure should be customized according to the individual study needs. Additional or fewer reports may be appropriate, but the templates serve as a starting point.

  • Shahnaz Khan, MPH
    Clinical Coordinator, Extramural Program
    NIAMS, NIH
    6701 Democracy Blvd. Suite 800
    Bethesda, MD 20892
    Phone: 301-594-2463
    Fax: 301-480-4543
    Email: khanshah@mail.nih.gov
    Anna Nicholson, MSHS
    Clinical Coordinator, Extramural Program
    NIAMS, NIH
    6701 Democracy Blvd. Suite 800
    Bethesda, MD 20892
    Phone: 301-594-2463
    Fax: 301-480-4543
    Email: nicholsona@mail.nih.gov