| Document Name | Type | Number | Download |
|---|---|---|---|
| Transfer of Jurisdiction Form | As Indicated | F-056 | icon-doc |
| Site Submission Simplified | Guidance | G-209 | icon-doc |
| Site Status Report for Periodic Review or Closure - Guidance | Guidance | G-059 | icon-pdf |
| E-Consent Certificate | As Indicated | F-140 | icon-doc |
| 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 |
| Document Name | Type | Number | Download |
|---|---|---|---|
| Generic Material Submission Form | As Indicated | F-009 | icon-doc |
| Site Submission Simplified | Guidance | G-209 | icon-doc |
| Continuing Review Report for Protocols - Guidance | Guidance | G-213 | icon-pdf |
| Annotated Central Study Questionnaire | Guidance | G-135 | icon-pdf |
| E-Consent Certificate | As Indicated | F-140 | icon-doc |
| E-Consent at Quorum Review - Client Guidance | Guidance | G-215 | icon-pdf |
| Generic Material Change Request Form | As Indicated | F-010 | icon-doc |
| Amendment Submission Cover Page | Recommended | F-011 | icon-doc |
| Central Study Information Change Request Form | Recommended | F-012 | icon-doc |
| Central Study Questionnaire | Required | F-013 | icon-doc |
| 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 |
| 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 |
| Additional Facility Site Information Questionnaire | As Indicated | F-038 | icon-doc |
| Site Information Questionnaire | Required | F-039 | 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 |
| Observational Registry Site Information Questionnaire | Required | F-101 | icon-doc |
| Human Subjects Research and Exemption Determination Request | As Indicated | F-118 | icon-doc |
| Site Submission Checklist | Guidance | G-010 | icon-doc |
| Amendment Submission Checklist | Guidance | G-024 | 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 |
| 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 |
| Consent Form Versioning Guidelines | Guidance | G-039 | icon-doc |
| Continuing Review Flowchart | Guidance | G-040 | icon-pdf |
| Submission Illustration for Central Studies | Guidance | G-041 | icon-pdf |
| 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 |
| Central Study Submission Checklist | Guidance | G-091 | icon-doc |
| Initial Protocol Submission for Single Site Study Checklist | Guidance | G-106 | icon-doc |
| Institutional Start-up Package | Guidance | icon-pdf |
