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Clinical Research
Updated September 10, 2007
NIAMS Guidelines and Policies for Clinical Trials
As part of its mandate, the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) supports numerous clinical research activities. The large numbers of complex studies that involve human subjects require the NIH to focus on the protection of human subjects and study integrity. Therefore, the conduct of such research is subject to a number of policy and oversight requirements. This Web site contains links to HHS and NIH policy statements and to a number of documents developed by NIAMS to assist investigators in meeting Federal oversight requirements and in conducting studies of the highest quality.
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Guidelines for Submission of Applications for Investigator-Initiated Clinical Trials
- NIAMS Policy: Request for a Planning Phase in Clinical Trial Applications
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NIAMS Policy: Conversion of a Grant to a Cooperative Agreement
General inquiries related to this document may be directed to:
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.govAnna Nicholson
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 -
Guidelines for Developing a MOOP
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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.
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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).
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Guidelines for Reporting to a Safety Officer
This document outlines the requirements for reporting to a Safety Officer, as well as the Safety Officer's role and responsibilities.
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Principal Investigator Responsibilities Related to the NIAMS 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.
NIH Guide Notice: AR-00-003, August 16, 2000
This document outlines the NIAMS policy and procedures for investigator-initiated clinical trials and provides guidelines for the preparation and submission of these applications. It lists the requirements placed on the receipt, review, and funding of these applications. General inquiries related to this document may be directed to:
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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 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 |
This document describes the NIAMS planning phase for NIAMS funded clinical trials (NIH Guide, Notice: AR-01-002, November 8, 2000).
The purpose of this document is to assist investigators in the preparation of a study Manual of Operating Procedures (MOOP) 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 patients and clinical sites.
