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.
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