NIAMS-funded investigators are encouraged to use the NIH/NIAMS tools and templates when developing their study documents. For further guidance or questions, reach out to the NIAMS Clinical Research Operations and Management Branch at NIAMSclinicaltrials@mail.nih.gov.
Protocol Templates for Clinical Trials
NIH-FDA Protocol Template for Phase 2 and 3 Clinical Trials
This template aims to facilitate the development of Phase 2 and 3 clinical trial protocols that require a Food and Drug Administration (FDA) Investigational New Drug (IND) or Investigational Device Exemption (IDE) application.
NIH Protocol Template for Behavioral and Social Science Research (BSSR) Involving Humans
This template is to help behavioral and social science researchers prepare research protocols for human studies studying a social and behavioral or social science-based intervention.
Clinical Monitoring and Data Management Plan (CMP/DMP) Checklist
This checklist is a tool to assist applicants and investigators in the development and writing of a CMP/DMP. The use of the checklist will ensure the applicant/investigator has considered all required aspects of the CMP/DMP. The checklist should only be use as a guide and does not need to be submitted as part of the clinical trial application.
NIAMS Templates for Developing a Manual of Operating Procedures (MOP)
The NIAMS has guidelines and templates to help investigators develop a study MOP. These templates support MOPs that will be developed for multi-site or single-site studies. The MOP is developed to facilitate consistency in protocol implementation and data collection across study visits, participants and clinical sites.
Multi-site MOP Guidelines & Templates
Single-site MOP Guidelines & Templates
How to Write a Data and Safety Monitoring Plan
The Data and Safety Monitoring Plan (DSMP) template serves as a guide to ensure the Principal Investigator (PI) has given consideration to the various aspects of the study which can impact data and safety of participants. This template has been developed by the NIAMS to assist the PI and the study team with the writing of a DSMP and details the elements to be included such as Study Overview, Participant Safety, Reportable Events, Interim Analysis and Stopping Rules, Data and Safety Monitoring, and Data Management, Quality Control and Quality Assurance. The DSMP is required for all clinical trials. The NIAMS may require a DSMP for clinical research (e.g., non-interventional) studies it supports that are monitored by a DSM body and will discuss with the PI which elements of the DSMP are appropriate to include in their plan. More information about the requirement for a DSMP are found in the NIAMS DSM Guidelines.
See the complete template for How to Write a Data and Safety Monitoring Plan (DSMP).
NIAMS Data and Safety Monitoring (DSM) Report Templates
These are templates developed for investigators, data managers, study statisticians and others involved in submitting periodic reports to the NIAMS-appointed, independent monitoring bodies (e.g., an independent Data and Safety Monitoring Board or Safety Officer). The proposed structure can be customized according to the individual study needs. The NIAMS templates can serve as a starting point for developing study specific reports but the NIAMS does not require they be followed.
Multi-site Study Report Templates
Single-site Study Report Templates
NIAMS Additional Study Tools and Templates
This document is used to track enrollment.
Milestone Timeline and Actual vs Expected Enrollment Graph
This document is used to track enrollment, milestones, and study progress.
Clinical Study Sample Size/Target Enrollment Number Change Request Form
The sample size/target enrollment change request form must be completed by the study team and submitted to the NIAMS for review when requesting a change in sample size and/or the overall target enrollment number.
Site Addition Request Form
The site addition request form must be completed by the study team and submitted to the NIAMS for review when requesting the addition of a new site to an ongoing clinical trial.
NIAMS Clinical Research Operations and Management Branch
Division of Extramural Activities (DEA)
6701 Democracy Blvd. Suite 800
Bethesda, MD 20892