- To assure the rights and well-being of human subjects participating in research are protected
- To educate researchers about how to improve study conduct
- To provide resources to the Research Community
Study Documentation Tool Box
These study templates provided are intended to help research teams:
- Document required information
- Organize study documents
- Track study procedures
- The template shouldn't influence what data you will collect; modify the template to collect the data you need.
- For those experienced with conducting studies for the pharmaceutical industry or for the NIH, variations of these forms may be familiar to you.
- All templates are in Microsoft document format and may be customized to meet protocol-specific requirements.
|Electronic Regulatory File Diagram||---|
|Good Clinical Practice Essential Document Checklist||---|
|Regulatory File Contents Description||---|
|Regulatory File Template GCP||---|
|Regulatory File Template nonGCP||---|
|Medical History Form|
|Physical Examination Form|
|Screen & Baseline Visit|
|Subject Demographic And Medical History Form|