|
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
|
|