Faculty
- Pre-Award Resources
- Research Resources for Faculty
- Resources for Faculty
Useful Research Information for Faculty & Staff
News/Events
Resources/Tools
Clinical Trial Study Process Flowchart
Clinical Trial Informed Consent Form Posting Requirements
FDA IND Safety Reports (SUSARs) Worksheet
Flowchart for Assessing Capacity to Consent
Form 1572 FDA - Completion Guide
Notification of Laboratory Ranges (NTF)
Research Acronyms (updated September 2024)
Research Glossary (updated May 2024)
Human Research Ethics and PI Responsibilities
Foundational Principles
- Belmont Report - Ethical Principles and Guidelines for the Protection of Human Subjects in Research
- COIMS International Ethical Guidelines - Health-Related Research Involving Humans
- Declaration of Helsinki - Medical Research Involving Human Participants
- Declaration of Taipei - Research on Health Databases, Big Data and Biobanks
- Ethical Considerations - Draft on Clinical Investigations Involving Medical Products in Children
- Informed Consent - FDA Guidance for IRBs, Clinical Investigators and Sponsors
Regulatory Standards and Investigator Guidance
- Common Rule - Federal Protection for Protection of Human Subjects
- ICH - Guideline for Good Clinical Practice E6(R3)
- Principal Investiagor - NIH PI Roles & Responsibilities
- RCI - UCSD Responsible Conduct of Research Institutional Plan
- UCSDSOG_003 - Investigator Responsibilities - Department-of-Neurosciences
SOGs - Standard Operating Guidance
Delegation of Authority SOG-004
Documenting Informed Consent Process Form SOG-007
Establishing a Single IRB (sIRB) Reliance and Submission Process SOG-005
Integrating Research Labs into Clinic Visits SOG-006
Investigator Responsibilities SOG-003
Investigator Site File (ISF) Organization SOG-009
Obtaining Informed Consent SOG-001
REDCap Project Build and Management Procedures SOG-010
Reporting Abnormal Research Lab Results SOG-008
Regulatory Compliance Research Tools for Teams
Customizable Templates
Adverse Event Log Template (June 2026)
Informed Consent Process - Documenting Template (May 2025)
IP Dispensation and Accountability Log Template (August 2024)
Medical History Review Form (November 2024)
Protocol Deviation Log (July 2026)
Study Personnel Licensure and Training Verification (August 2024)
Newsletters