| Transfer of Jurisdiction Form |
As Indicated |
F-056 |
icon-doc |
| Site Status Report for Periodic Review or Closure - Guidance |
Guidance |
G-059 |
icon-pdf |
| E-Consent at Quorum Review - Client Guidance |
Guidance |
G-215 |
icon-pdf |
| Federal Funding Addendum |
As Indicated |
F-015 |
icon-doc |
| Institutional Jurisdiction Waiver Form |
As Indicated |
F-016 |
icon-doc |
| Continuing Review Report for Protocols |
Required |
F-017 |
icon-doc |
| Protocol Deviation (Major) /Violation Report |
Required |
F-018 |
icon-doc |
| Device Study Submission Form |
As Indicated |
F-019 |
icon-doc |
| Safety Information and Unanticipated Problem Cover Page |
Required |
F-021 |
icon-doc |
| Serious Adverse Event Report |
Required |
F-022 |
icon-doc |
| Unanticipated Problem Report |
Required |
F-024 |
icon-doc |
| Board Meeting Schedule |
Guidance |
F-025 |
icon-pdf |
| California Experimental Subject's Bill of Rights - English |
Supplemental |
F-026 |
icon-doc |
| California Experimental Subject's Bill of Rights - Spanish |
Supplemental |
F-027 |
icon-doc |
| Change in Primary Facility Form |
Required |
F-028 |
icon-doc |
| Change in Principal Investigator Form |
Required |
F-029 |
icon-doc |
| Compensation Template |
As Indicated |
F-030 |
icon-doc |
| Conflict of Interest Statement |
As Indicated |
F-031 |
icon-doc |
| CV Template |
Guidance |
F-032 |
icon-doc |
| CV Sample |
Guidance |
F-033 |
icon-doc |
| Institutional Authorization Agreement |
As Indicated |
F-034 |
icon-doc |
| Prospective Protocol Waiver/Exception Request Form |
Required |
F-035 |
icon-doc |
| Single Site Study Questionnaire |
Required |
F-036 |
icon-doc |
| Change Request Form for Sites |
Required |
F-037 |
icon-doc |
| Additional Facility Site Information Questionnaire |
As Indicated |
F-038 |
icon-doc |
| Site Information Questionnaire |
Required |
F-039 |
icon-doc |
| Site Status Report |
Required |
F-040 |
icon-doc |
| Reopen Request Form for Sites |
Guidance |
F-048 |
icon-doc |
| Waiver of Documentation of Informed Consent Submission Form |
As Indicated |
F-042 |
icon-doc |
| Waiver or Alteration of Informed Consent Submission Form |
As Indicated |
F-043 |
icon-doc |
| Request for Waiver or Alteration of HIPAA Authorization Requirement |
As Indicated |
F-044 |
icon-doc |
| Recruitment and Participant Study Materials Coversheet |
Required |
F-046 |
icon-doc |
| Site Status Report Checklist |
Guidance |
F-047 |
icon-doc |
| Observational Registry Site Information Questionnaire |
Required |
F-101 |
icon-doc |
| Observational Registry & Qualified Minimal Risk Site Status Report |
Required |
F-117 |
icon-doc |
| Site Submission Checklist |
Guidance |
G-010 |
icon-doc |
| Recruitment and Participant Study Materials Guidelines |
Guidance |
G-033 |
icon-doc |
| Client Guide to Consent Form Evaluation (Requires an OnQ Portal Account) |
Guidance |
G-034 |
icon-aspx |
| Consenting Research Participant Guidelines |
Guidance |
G-035 |
icon-doc |
| Safety Information and Unanticipated Problems Guidelines |
Guidance |
G-036 |
icon-doc |
| Site Information Questionnaire Workbook |
Guidance |
G-037 |
icon-doc |
| Changes to Site Information - Guidelines |
Guidance |
G-038 |
icon-doc |
| Consent Form Versioning Guidelines |
Guidance |
G-039 |
icon-doc |
| Safety and Unanticipated Problems Powerpoint |
Guidance |
G-042 |
icon-pdf |
| Handbook for Quorum Review IRB (Requires an OnQ Portal Account) |
Guidance |
G-043 |
icon-aspx |
| Initial Protocol Submission for Single Site Study Checklist |
Guidance |
G-106 |
icon-doc |
| Institutional Start-up Package |
Guidance |
|
icon-pdf |
