NIAMS has standardized procedures and provides templates to ensure compliance and the safety of human subjects.

Peer review of properly completed applications submitted in response to the Program Announcements will be conducted by the NIAMS AMS Clinical Trials Review Committee. This review committee will provide expertise in NIAMS disease areas and in clinical trial methodology.

Learn more about NIAMS data and safety monitoring guidelines and policies that ensure the health and welfare of clinical trial participants.

PROMIS® developed pediatric measures for the functions, symptoms, behaviors, and feelings shown here. Self-report measures are used for children ages 5-17. Parent proxy-report measures are used for children ages 5-17. Measures are applicable to the general population and to those with chronic conditions.

PREFACE Investigators should consider using this template when developing the Data and Safety Monitoring Plan (DSMP) for clinical studies funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The goal of the DSMP is to provide a general description of a plan that you intend to

Learn about the NIH and NIAMS policies and requirements for Data and Safety Monitoring (DSM), guidelines for creating a Data and Safety Monitoring Plan (DSMP), risk assessment and determination of monitoring type, types of monitoring bodies NIAMS may consider, and much more. Additional reporting requirements, such as the Institutional Review

The NIH and other Federal agencies have developed policies, regulations, and guidelines for investigators to follow for conducting safe, ethical, and high-quality clinical research. This page provides information that includes but is not limited to federal and NIH human subjects research policies and guidelines for monitoring clinical research, education and training for investigators, and privacy and protecting confidentiality.

The clinical study Principal Investigator (PI) safety monitoring responsibilities with respect to a Data and Safety Monitoring Board (DSMB) or Observational Study Monitoring Board (OSMB) ensure the study is conducted according to the highest scientific and ethical standards. Responsibilities are outlined in bold italics.

Principal investigators must report issues of trial participant safety, scientific integrity, and ethical conduct to a designated Safety Officer.

NIAMS-funded investigators are encouraged to use the NIH/NIAMS tools and templates when developing their study documents.

Acknowledging your NIAMS/NIH support NIH is here to support you. When you communicate your research findings to the world, please acknowledge relevant NIAMS/NIH funding in research papers, presentations, news releases, and other communications. This helps fulfill our commitment to inform the American public about the vital role of the NIH

Anyone, an individual or an organization, can donate to the NIAMS. The NIAMS is federally funded and not a fundraising organization; but, the U.S. Congress authorizes NIAMS to accept donations and bequests to support the scientific mission of the Institute. Donations to NIAMS are deposited in a NIAMS “Gift Fund”

Statement for the Record Posted on August 2, 2016 Prepared Statement of Stephen I. Katz, M.D., Ph.D., Director National Institute of Arthritis and Musculoskeletal and Skin Diseases ______________________________________ Mr. Chairman and Members of the Committee: I am pleased to present the President’s Fiscal Year (FY) 2017 budget request for the

Investigators are strongly encouraged to consult with NIAMS, at [email protected], prior to submitting an application to any of the NIAMS clinical funding opportunities (NOFOs). Consultation prior to submission of an application allows the Program Officer to discuss with the investigator the extent to which the potential project fits with NIAMS

NIAMS hosts and participates in a number of working groups and committees that bring together representatives from the scientific and lay communities to work collectively and collaboratively.

NIH established the Lupus Federal Working Group, led by NIAMS, the lead federal agency for research on lupus.

February 2016 NOTE: The FY 2016 Enacted funding amounts cited throughout this chapter reflect the effects of OAR HIV/AIDS Transfers. Organization Chart View a larger version of the organization chart. Top Appropriation Language NATIONAL INSTITUTES OF HEALTH National Institute of Arthritis and Musculoskeletal and Skin Diseases For carrying out section