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
Guidelines 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.
Report Templates for Studies with Data and Safety Monitoring Oversight
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)
Site Addition Request Form
PDF Version (PDF – 207 KB)
Actual vs Expected Enrollment Graph
Word Version (DOC – 83.5 KB)
Shahnaz Khan, M.P.H.
Clinical Research Manager, Extramural Program
6701 Democracy Blvd. Suite 800
Bethesda, MD 20892