Clinical Research Support
Office for the Protection of Research Subjects (OPRS)
Investigator Resources
OPRS Information Sheets
Investigator Resource Links | Quick Links |
1) OPRS Information Sheets
- Additional Protections for Children
- Adverse Event Ranking Scale
- Advertising Information about Clinical Trials
- Common Issues Holding Up Protocol Reviews
- Determining if Project Is Human Subject Research
- Expedited and Exempt Categories
- FDA Medical Devices Information
- *NEW* The FDA's Drug Review Process: Ensuring Drugs Are Safe and Effective
- General Requirements for Informed Consent
- *NEW* Guidance on Completing the Protocol Front Sheet
- *NEW* HIPAA Research Guidance Document
- *NEW* How to Contact the FDA
- Instructions for Obtaining & Documenting Informed Consent of Non-English Speaking Subjects
- Instructions on the Collection and Sharing of Data and Tissue Specimens
- Legally Authorized Representatives
- Linked and Anonymous Specimens
- Massachusetts Law on Insurance Coverage for Clinical Trials
- Microsoft Word Tips and Tricks
- Procedures for Monitoring Consent Process
- Partners Recruitment of Subjects Policy
- Requirements to Involve Prisoners as Participants in Research
- Single Patient IND and Emergency Use of a Test Article
- Quality Assurance Office for Clinical Trials (QACT)
- Clinical Research Unit (CRU)
- Clinical Trials Education Office (CTEO)
- Protocol Review and Monitoring System (PRMS)
