What’s Inside?

This page has been created as a resource for both investigators and research staff to use throughout the research process.  Included are links to guidance and policy references, as well as suggestions on how to establish and maintain compliance.

Specifically, there are links to Standard Operating Procedure (SOP) templates, sample forms and checklists, and suggestions for practical strategies for organization of documentation and research records. 

Purpose of OSHR Monitoring and Auditing

1. Institutional Perspective

Researcher’s Tool-Kit

1. Standard Operating Procedure Templates and Instructions

2. Sample Forms, Checklists, and Logs

JHM Policy and Guidance

1. Compliance Specific References

2. Research and Compliance Acronyms and Abbreviations

3. Common Compliance Terms

Compliance Routine Monitoring and Auditing Process

1. Internal Monitoring Process and Site Preparation

2. Internal “for-cause” or “directed” Audit Process and Site Preparation

3. How to Prepare for an FDA Inspection

4. Compliance Monitoring Program - Educational Seminars

If you have any questions regarding the Compliance Monitoring Program, or an upcoming audit, contact one of our Compliance Monitors: