The following guidelines and templates ensure consistent operating procedures and oversight for clinical research studies.

Clinical Trial Protocol Template

NIH-FDA Phase 2 and 3 IND/IDE Clinical Trial Protocol Template

Protocol template (DOC – 349 KB)

Protocol template (PDF – 1469 KB)

Templates for Developing a Manual of Operating Procedures (MOOP)

Guidelines and templates for developing a clinical study MOOP to facilitate consistency in protocol implementation and data collection across staff, patients and clinical sites.

Multi-site MOOP

Guidelines (PDF – 559 KB)

Guidelines (DOC – 514 KB)

Appendix A (PDF – 56 KB)

Appendix A (DOC – 20 KB)

Appendix B (PDF – 81 KB)

Appendix B (DOC – 20 KB)

Appendix C (PDF – 89 KB)

Appendix C (DOC – 27 KB)

Appendix D (PDF – 57 KB)

Appendix D (DOC – 17 KB)

Appendix E (PDF – 45 KB)

Appendix E (DOC – 14 KB)

Appendix F (PDF – 77 KB)

Appendix F (DOC – 35 KB)

Appendix G (PDF – 96 KB)

Appendix G (DOC – 17 KB)

Single-site MOOP

Guidelines ((PDF – 1.29 MB)

Guidelines (DOC – 520 KB)

Appendix A (PDF – 70 KB)

Appendix A (DOC – 20 KB)

Appendix B (PDF – 46 KB)

Appendix B (DOC – 20 KB)

Appendix C (PDF – 410 KB)

Appendix C (DOC – 27 KB)

Appendix D (PDF – 51 KB)

Appendix D (DOC – 17 KB)

Appendix E (PDF – 44 KB)

Appendix E (DOC – 14 KB)

Appendix F (PDF – 71 KB)

Appendix F (DOC – 35 KB)

Appendix G (PDF – 96 KB)

Appendix G (DOC – 17 KB)

Data and Safety Monitoring Board Report Templates

Templates for investigators, study staff, data managers, study statisticians and others involved in submitting periodic reports to NIAMS-appointed, independent monitoring bodies (e.g., an independent Data and Safety Monitoring Board or Safety Officer). The proposed structure should be customized according to the individual study needs. Additional or fewer reports may be appropriate, but the templates serve as a starting point.

Multi-site Templates

Open Session Reports (PDF – 109 KB)

Closed Session Reports (PDF – 770 KB)

Single-site Templates

Open Session Reports (PDF – 770 KB)

Closed Session Reports (PDF – 770 KB)

Additional Forms and Templates 

Target Enrollment Change Request Form

PDF Version (PDF – 612 KB)

Word Version (DOC – 22 KB)

Site Addition Request Form

PDF Version (PDF – 207 KB)

Word Version (DOC – 22 KB)

Actual vs Expected Enrollment Graph

Word Version (DOC – 83.5 KB)

Contact Us

Shahnaz Khan, M.P.H.
Clinical Research Manager, Extramural Program
NIAMS, NIH
6701 Democracy Blvd. Suite 800
Bethesda, MD 20892
Phone: 301-594-2463
khanshah@mail.nih.gov

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