Sponsor and Site Forms
| Document Name | Type | Number | Download |
|---|---|---|---|
| Institutional Jurisdiction Waiver Form | As Indicated | F-016 |
|
| Protocol Deviation (Major) /Violation Report | Required | F-018 |
|
| Federal Funding Addendum | As Indicated | F-015 |
|
| Device Study Submission Form | As Indicated | F-019 |
|
| Safety Information and Unanticipated Problem Cover Page | Required | F-021 |
|
| Serious Adverse Event Report | Required | F-022 |
|
| Unanticipated Problem Report | Required | F-024 |
|
| Board Meeting Schedule | Guidance | F-025 |
|
| California Experimental Subject's Bill of Rights - English | Supplemental | F-026 |
|
| California Experimental Subject's Bill of Rights - Spanish | Supplemental | F-027 |
|
| Change in Primary Facility Form | Required | F-028 |
|
| Change in Principal Investigator Form | Required | F-029 |
|
| Institutional Authorization Agreement | As Indicated | F-034 |
|
| Prospective Protocol Waiver/Exception Request Form | Required | F-035 |
|
| Change Request Form for Sites | Required | F-037 |
|
| Compensation Template | As Indicated | F-030 |
|
| Conflict of Interest Statement | As Indicated | F-031 |
|
| CV Template | Guidance | F-032 |
|
| CV Sample | Guidance | F-033 |
|
| Single Site Study Questionnaire | Required | F-036 |
|
| Additional Facility Site Information Questionnaire | As Indicated | F-038 |
|
| Site Information Questionnaire | Required | F-039 |
|
| Site Status Report | Required | F-040 |
|
| Waiver of Documentation of Informed Consent Submission Form | As Indicated | F-042 | |
| Waiver or Alteration of Informed Consent Submission Form | As Indicated | F-043 | |
| HIPAA – Request for Complete Waiver of Authorization | As Indicated | F-044 |
|
| HIPAA – Request for Partial Waiver of Authorization for Research Recruitment Purposes | As Indicated | F-045 |
|
| Recruitment and Participant Study Materials Coversheet | Recommended | F-046 |
|
| Site Status Report Checklist | Guidance | F-047 |
|
| Reopen Request Form for Sites | Required | F-048 |
|
| Principal Investigator Generated Study Questionnaire | Required | F-049 |
|
| Site Submission Checklist | Guidance | G-010 |
|
| Recruitment and Participant Study Materials Guidelines | Guidance | G-033 |
|
| Consent Form Development Guide | Guidance | G-034 |
|
| Consenting Research Participant Guidelines | Guidance | G-035 |
|
| Safety and Unanticipated Problem Guidelines | Guidance | G-036 |
|
| Site Information Questionnaire Workbook | Guidance | G-037 |
|
| Changes to Site Information - Guidelines | Guidance | G-038 |
|
| Consent Form Versioning Guidelines | Guidance | G-039 |
|
| Safety and Unanticipated Problems Powerpoint | Guidance | G-042 |
|
| Handbook for Quorum Review IRB | Guidance | G-043 |
|
| Initial Protocol Submission for Single Site Study Checklist | Guidance | G-106 |
|
| Document Name | Type | Number | Download |
|---|---|---|---|
| Generic Material Submission Form | As Indicated | F-009 |
|
| Generic Material Change Request Form | As Indicated | F-010 |
|
| Amendment Submission Cover Page | Recommended | F-011 |
|
| Central Study Information Change Request Form | Recommended | F-012 |
|
| Central Study Questionnaire | Required | F-013 |
|
| Canadian Extension Central Study Questionnaire | As Indicated | F-014 |
|
| Federal Funding Addendum | As Indicated | F-015 |
|
| Institutional Jurisdiction Waiver Form | As Indicated | F-016 |
|
| Continuing Review Report for Protocols | Required | F-017 |
|
| Device Study Submission Form | As Indicated | F-019 |
|
| Exemption Determination Request | As Indicated | F-020 |
|
| Safety Information and Unanticipated Problem Cover Page | As Indicated | F-021 |
|
| Board Meeting Schedule | Guidance | F-025 |
|
| Institutional Authorization Agreement | As Indicated | F-034 |
|
| Prospective Protocol Waiver Exception Request Form | Required | F-035 |
|
| Waiver of Documentation of Informed Consent Submission Form | As Indicated | F-042 | |
| Waiver or Alteration of Informed Consent Submission Form | As Indicated | F-043 | |
| HIPAA Request for Complete Waiver of Authorization | As Indicated | F-044 |
|
| HIPAA Request for Partial Waiver of Authorization for Research Recruitment Purposes | As Indicated | F-045 |
|
| Recruitment and Participant Study Materials Coversheet | Recommended | F-046 |
|
| Amendment Submission Checklist | Guidance | G-024 |
|
| Recruitment and Participant Study Materials Guidelines | Guidance | G-033 |
|
| Consent Form Development Guide | Guidance | G-034 |
|
| Consenting Research Participant Guidelines | Guidance | G-035 |
|
| Safety Information and Unanticipated Problems Guidelines | Guidance | G-036 |
|
| Consent Form Versioning Guidelines | Guidance | G-039 |
|
| Continuing Review Flowchart | Guidance | G-040 |
|
| Submission Illustration for Central Studies | Guidance | G-041 |
|
| Safety and Unanticipated Problems Powerpoint | Guidance | G-042 |
|
| Handbook for Quorum Review IRB | Guidance | G-043 |
|
| Central Study Submission Checklist | Guidance | G-091 |
|
| Initial Protocol Submission for Single Site Study Checklist | Guidance | G-106 |
|