Our IRB has many forms. Our intent is not
to confuse with so many forms; rather, we want to provide the best possible
service to clients by providing forms that meet their individual needs. We
would love to hear your comments at any time so that we might improve the
forms.
| No. |
Description |
Acrobat |
Word |
|
|
|
|
|
 |
 |
| 1. Initial Review Form |
|
4-05 |
Grant Review Conceptual Approval |
|
405.doc |
|
|
4-06 |
Determination Research with Human Subjects |
|
406.doc |
|
|
4-07A |
Exemption Initial Application |
|
407A.doc |
|
|
4-10 |
CHECKLIST - START HERE For All Studies |
|
410.doc |
|
|
4-12A |
Cover Form Non-Clinical |
|
412A.doc |
|
|
4-12B |
Cover Form FDA Regulated |
|
412B.doc |
|
|
4-12C |
Cover Form Program Evaluation |
|
412C.doc |
|
|
4-13A |
Study Supplement Expedited Review |
|
413A.doc |
|
|
4-13B |
Study Supplement Device |
|
413B.doc |
|
|
4-13C |
Study Supplement Drug |
|
413C.doc |
|
|
4-16A |
Special Population Employees |
|
416A.doc |
|
|
4-16B |
Special Population Pregnant Women |
|
416B.doc |
|
|
4-16D |
Special Population Children |
|
416D.doc |
|
|
| 2. Principal Investigator |
|
4-20A |
PI Application Non-Clinical |
|
420A.doc |
|
|
4-20B |
PI Application Clinical |
|
420B.doc |
|
|
4-21A |
PI Supplement Conflict of Interest |
|
421A.doc |
|
|
4-21C |
PI supplement Satellite site |
|
421C.doc |
|
|
4-22 |
PI Supplement Waiver from Local IRB |
|
422.doc |
|
|
4-25A |
PI Supplement Request for Waiver of Consent Process |
|
425A.doc |
|
|
4-25B |
PI Supplement Request for Waiver of Consent Documentation |
|
425B.doc |
|
|
4-25C |
PI Supplement Request for Waiver of Authorization HIPAA |
|
425C.doc |
|
|
4-25D |
PI Supplement Request for Waiver of Consent FERPA |
|
425D.doc |
|
|
| 3. Study Action Forms |
|
4-31A |
Continuing Review Non-Clinical |
|
431A.doc |
|
|
4-31B |
Continuing Review Clinical |
|
431B.doc |
|
|
4-31C |
Continuing Review Sponsor |
|
431C.doc |
|
|
4-31D |
Continuing Review List of Events |
|
431D.doc |
|
|
4-31E |
Check-in Grant |
431E.pdf |
431E.doc |
|
|
4-31F |
Check-in Exemption |
|
431F.doc |
|
|
4-32 |
Request Study Modification |
|
432.doc |
|
|
4-33 |
Request Change of PI site |
|
433.doc |
|
|
4-35A |
Report Problem |
|
435A.doc |
|
|
4-35B |
Report Serious AE |
|
435B.doc |
|
|
4-35C |
Report Violation, Noncompliance, exception |
|
435C.doc |
|
|
4-37 |
Request Record Request |
|
437.doc |
|
|
4-39A |
Final Report Investigator |
|
439A.doc |
|
|
4-39C |
Final Report Sponsor |
|
439C.doc |
|
|
| 4. Specialty Forms |
|
4-40A |
Assistance HIPAA |
|
440A.doc |
|
|
4-41A |
Biol Spec Checklist |
441A.pdf |
441A.doc |
|
|
4-41B |
Biol Spec Expedited review of Protocol |
441B.pdf |
441B.doc |
|
|
4-41C |
Biol Spec PI Application |
441C.pdf |
441C.doc |
|
|
4-41D |
Biol Spec Waste - Secondary Acquisition |
441D.pdf |
441D.doc |
|
|
4-41E |
Biol Spec Continuing Review |
441E.pdf |
441E.doc |
|
|
4-42 |
Assistance HUD |
|
442.doc |
|
|
4-42A |
Cover Form HUD/HDE |
442A.pdf |
442A.doc |
|
|
4-42B |
Application HUD/HDE Primary Physician Application |
442B.pdf |
442B.doc |
|
|
4-42C |
Continuing Review HUD/HDE Primary Physician |
|
442C.doc |
|
|
4-42D |
Continuing Review HUD/HDE Sponsor |
|
442D.doc |
|
|
4-43 |
FWA IRB Authorization Agreement |
443.pdf |
443.doc |
|
|
| 5. IRC Business Forms |
|
4-50A |
Indemnification Spon for 1 PI |
450A.pdf |
450A.doc |
|
|
4-50B |
Indemnification Sponsor |
450B.pdf |
450B.doc |
|
|
4-50C |
Indemnification Institutional |
450C.pdf |
450C.doc |
|
|
4-50D |
Indemnification Individual PI |
450D.pdf |
450D.doc |
|
