| Post-Approval
Reporting Requirements |
| • |
Summary
Sheet for Post-Approval Reporting Requirements |
| • |
Adverse
Events (AE) Reporting Guidelines |
| • |
Reporting
Violations and Incidents in Research Protocols |
| • |
Reporting
and Responding to Research-Related Concerns and Complaints |
 |
| Information Security |
| |
• |
Information Security and Human Subjects Research (Revised:
February 2008) |
|
| Types
of Research |
| |
Experimental
Drugs, Devices and Biologics |
| |
• |
Investigational
New Drugs and Biologics (Revised:
February 2008) |
| |
• |
Investigational
Devices (Revised:
February 2008) |
| |
• |
Significant and Non-significant Risk Devices
(Revised:
February 2008) |
| |
• |
Emergency
Use and Compassionate Use of Experimental
Drugs and Devices |
| |
• |
Use
of Inactive Interventions (e.g., Placebos) in Place of Potentially
Effective Therapy |
|
| |
Medical
Records Review |
|
| |
Research
in Emergency Settings |
|
| |
Laboratory
Test Results: CLIA Compliance |
|
| |
Human Tissues
and Cells |
| |
• |
UCSF
Guide for the Research Use of Human Biological Specimens:
Collecting, Banking, and Sharing Specimens |
| |
• |
Research
Using Human Biological Specimens |
| |
• |
Mandatory
Companion Studies: Registries, Data Banks, Collections Of
Biological Specimens
Or Genetic Materials |
| |
• |
Sample Consent Form: Specimen
Collection |
| |
• |
Patient Information: Donating
Tissue for Research |
| |
|
• |
Donating
Tissue for Medical Research HTML page for easy viewing |
| |
|
• |
Donating
Tissue for Research PDF Brochure for printing & distributing
to subjects |
| |
• |
Human
Stem Cell Research |
|
| |
Human Gene Transfer/Recombinant DNA Research |
|
| |
Clinical
Trials (under development) |
| |
• |
Data and Safety
Monitoring Plans |
| |
|
• |
Information
Sheet for Data Safety Monitoring Plans |
| |
|
• |
General Clinical Research Center |
| |
|
• |
Data and Safety Monitoring Boards (NEW January 2008) |
|
| |
Social
and Behavioral Research |
|
| |
Epidemiological
Research (under development) |
| |
• |
Death
Data Files |
| |
| Vulnerable
Subject Populations |
| |
• |
Children and Minors |
| |
|
• |
Children and Minors
in Research |
| |
|
• |
Chart: Criteria
for Approving Research on Children |
|
| |
• |
Those With Cognitive Impairments |
| |
|
• |
Those With Cognitive
Impairments |
| |
|
• |
Decisional
Capacity Assessment Flowchart |
|
| |
• |
Pregnant Women, Fetuses,
Neonates or In Vitro Fertilization |
| |
|
• |
Research Involving
Pregnant Women, Fetuses, Neonates, or Human in Vitro Fertilization |
| |
|
• |
Chart:
Criteria for Approving Research Involving Pregnant Women,
Fetuses, and Neonates |
|
| |
• |
Prisoners |
| |
|
• |
Research Involving
Prisoners |
| |
|
• |
Chart: Criteria
for Approving Research Involving Prisoners |
|
| |
• |
Those Who Do Not Read, Speak
or Understand English |
| |
|
• |
Those
Who Do Not Read, Speak or Understand English |
|
| |
• |
Research in Emergency Settings |
| |
|
• |
Research in Emergency
Settings |
|
| |
• |
Surrogate Consent |
| |
|
• |
Surrogate Consent |
| |
| Financial
Issues |
| |
• |
Investigator
Conflict of Interest and CHR Review |
| |
• |
Payment
of Research Subjects |
| |
• |
Accounts
Payable Procedures |
| |
• |
Treatment
and Compensation for Injury |
|
| CHR
Guidelines "Blue Book" (Table of Contents, 1999 version) |
