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-FDA Protocol Template for Phase 2 and 3 Clinical Trials

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.

NIH Protocol Template for Behavioral and Social Science Research (BSSR) Involving Humans

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

NIAMS Multi-site MOP Template

Multi-site Appendix A: Sample Adverse Event Form

Multi-site Appendix B: Sample Serious Adverse Event Form

Multi-site Appendix C: Sample Unanticipated Problem Form

Multi-site Appendix D: Sample Protocol Deviation Log

Multi-site Appendix E: Sample Informed Consent Process Checklist

Multi-site Appendix F: Sample Eligibility Checklist

Multi-site Appendix G: Sample Case Report Forms and Completion Instructions

Multi-site Appendix G-1: Demographics Form 

Multi-site Appendix G-2: Medical History Form 

Multi-site Appendix G-3: Prior and Concomitant Medications Form 

Multi-site Appendix G-4: Vital Signs Form

Multi-site Appendix G-5: Study Disposition Form

Multi-site Appendix H: Sample Clinical Trial Closeout Procedures

Single-site MOP Guidelines & Templates

NIAMS Single-site MOP Template

Single-site Appendix A: Sample Adverse Event Form

Single-site Appendix B: Sample Serious Adverse Event Form

Single-site Appendix C: Sample Unanticipated Problem Form

Single-site Appendix D: Sample Protocol Deviation Log

Single-site Appendix E: Sample Informed Consent Process Checklist

Single-site Appendix F: Sample Eligibility Checklist

Single-site Appendix G: Sample Case Report Forms and Completion Instructions

Single-site Appendix G-1: Demographics Form 

Single-site Appendix G-2: Medical History Form 

Single-site Appendix G-3: Prior and Concomitant Medications Form 

Single-site Appendix G-4: Vital Signs Form

Single-site Appendix G-5: Study Disposition Form

Single-site Appendix H: Sample Clinical Trial Closeout Procedures

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

Open Data Report (Aggregate) Template

Closed Data Report (by Unmasked Group) Template 

Single-site Study Report Templates

Open Data Report (Aggregate) Template

Closed Data Report (by Unmasked Group) Template

NIAMS Additional Study Tools and Templates

Enrollment Report

This document is used to track enrollment.

Enrollment Report

Milestone Timeline and Actual vs Expected Enrollment Graph

This document is used to track enrollment, milestones, and study progress.

Milestone Enrollment Graph

NIAMS 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. 

Sample Size/Target Enrollment Number Change Request Form

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.

Site Addition Request Form

Contact Us

NIAMS Clinical Research Operations and Management Branch
Division of Extramural Activities (DEA)
6701 Democracy Blvd. Suite 800
Bethesda, MD 20892
Phone: 301.594.2463
NIAMSclinicaltrials@mail.nih.gov
 

 

Last Updated: December 2022