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Frequently Asked Questions for Investigators Conducting NIAMS-Funded Clinical Research Studies

https://www.niams.nih.gov/grants-funding/funding-opportunities/supported-scientific-areas/frequently-asked-questions-investigators-conducting-niams-funded-clinical-research-studies

TABLE OF CONTENTS TERMINOLOGIES AND DEFINITIONS GENERAL DATA AND SAFETY MONITORING AND OVERSIGHT STUDY DOCUMENTS NIAMS CLINICAL FUNDING OPPORTUNITIES, REVIEW AND AWARD ANCILLARY STUDIES HUMAN SUBJECTS AND CLINICAL TRIALS INFORMATION FORM CLINICALTRIALS.GOV TRAINING REQUIREMENTS FOR CLINICAL TRIALS

Data and Safety Monitoring (DSM) Guidelines for Internal Safety Monitoring

https://www.niams.nih.gov/grants-funding/conducting-clinical-trials/clinical-trial-policies-guidelines-and-templates/data-0

Learn NIAMS guidance and guidelines for studies that use internally-appointed monitoring for the oversight of NIAMS-funded clinical research. TABLE OF CONTENTS 1.0 Internally-appointed Monitoring 1.1 Roles and Responsibilities of the PI 1.2 Responsibilities of Internally-appointed Monitoring Body 1.2.a Internal Safety Monitoring Process 1.2.b Internal Review of Data and Safety Reports

Scientific Director

https://www.niams.nih.gov/about/niams-leadership/scientific-director-of-intramural-research

The Office of the Scientific Director (OSD) is responsible for oversight, review, and administration of the Intramural Research Program (IRP) at the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). The OSD has several key functions, including planning, coordinating, and directing the basic and clinical scientific research programs conducted within the IRP.

Typically materials from NIAMS that are more than 5 years old will be archived.