Clinical Research

Updated March 23, 2017

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 Research Manager.

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

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.

  • Data and Safety Monitoring (DSMP) Template and Guidelines

    The purpose of this document is to provide a template for writing a data and safety monitoring plan for NIAMS supported clinical research studies. Investigators should refer to it as a guidance to assist with data and safety monitoring activities.

  • Sample Data and Safety Monitoring Board (DSMB Charter)

    The purpose of the Charter is to outline the NIAMS charge to the DSMB regarding its responsibilities, composition, and processes for a NIAMS funded study. It is intended to be a living document to be modified at any time. This is a sample DSMB Charter that is modified by the NIAMS for individual studies that require NIAMS-appointed data and safety monitoring oversight.

  • 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.

  • Additional Forms and Templates
Shahnaz Khan, MPH
Clinical Research Manager, 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