Index
- AAHRPP
-
Administrative Hold
- Adverse Events
-
Adverse Event Log Template (DOCX)
- Advertisement Guidance
- Alteration of Consent
- Amendments (Major Vs. Minor)
- Amendments and Renewals
- Ancillary Reviews
- Appeals
-
Approval Criteria - WVU IRB
- Approval in Principle
-
Approved Technology for Research
- Assent - Child
- Assent - Diminished Capacity
- Case Study Types
- Commercial IRB
- Certificate of Confidentiality (NIH Portal)
- Change in PI (DOCX)
-
Children
- Child Online Privacy Protection Act (COPPA)
- Clinical Trials.gov
- Clinical Trials at WVU
- Closure (Study/Protocol)
- CITI Training
- CITI Administrator Access Request
- Code of Federal Regulations FDA 21 CFR 56
- Code of Federal Regulations HHS 45 CFR 46
- Common Rule 2018
- Complaints (Participants, Others)
- Conflict of Interest (Researchers)
- Conflict of Interest (IRB Members) (DOCX)
- Consent Form Development Guidance
- Continuing Reviews
- Data Protection Process
- Research Data and Technology at WVU
- Definitions
- Data Safety Monitoring Plan Template (DOCX)
- Data Safety Monitoring Board
- Data Destruction and Retention
- Data Agreements
-
Decedent Research HIPAA Authorization
- De-Identified Data (HIPAA)
- Department of Justice Research see National Institute of Justice (NIJ) if NIJ funded
- Department of Defense Research
- Delegation of Authority Log Template (DOCX)
- Deviations
- Deviation Log Template (DOCX)
- Devices (IDE)
- Drugs (IND)
- Duality of Interest
- Education - Research Community
- Electronic Informed Consent (eIC)
- Electronic HIPAA Authorizations
-
Emergency Use
- Enrollment (Close/Re-Open)
- Event Reporting (Includes Deviations, Adverse Events, and Research Event Definitions)
- Exempt Categories
-
Expanded Access
- Expedited Categories
- External IRB
- Extra Credit Policies
- Incidental Findings
- iLab Access
- Information Access Request (WVU Build Form)
- Informed Consent:
- Assent - Child Research
- Assent - Diminished Capacity
- Development Guidance
- Elements of Informed Consent
-
General Guidance
- ICH Good Clinical Practice
- dbGAP (NIH Database Gentypes and Phenotypes)
- FDA
- HHS
-
Remote Consent
- Institutional Review Boards - WVU
- Institutional Review Boards - Other
-
International Research (DHHS OHRP Guidance)
- International Research (Institutional Requirements)
- Investigator Holds
- Investigational Device
- Investigator as a Sponsor (DOCX)
- Off-Label Drugs and Biologics (See FAQ Q1)
- Online Survey Guidance
- Participant Photo/Media Authorization (DOCX)
- Participant Payment
- Pharmacy Policy
- Post Approval Actions
- Pre Approval Actions
- Pre-paid Card Program
- Privacy and Confidentiality for Research Participants
- Program Evaluation
- Protected Health Information (PHI)
- Personally Identifiable Information (PII) WVU Policy
- Protected Populations in Research
- Pregnant Women, Fetuses, and Neonates
- Prisoners
- Prisoners in Research (DHHS OHRP Guidance)
- Protocol Types