Forms

Download IRC's Forms

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.

In Completing any IRC forms, please remember 2 rules:

Rule # 1: Use common sense; Rule # 2: Answer every question. If a blank is empty the IRB will have no way to know if you forgot it or left it blank on purpose. Please say "n/a" or "?" if you believe that to be appropriate.

NOTE: Please remember, as you complete a MS Word template form, the form will grow longer. We expect that to happen.

 
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 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 Request 413A.doc
4-13B Study Supplement Device 413B.doc
4-13C Study Supplement Drug 413C.doc
4-16A Special Pop Employees 416A.doc
4-16B Special Pop Pregnant Women 416B.doc
4-16D Special Pop 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
4-22 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 Site Change or Addition 433.doc
4-35A Report Problem 435A.doc
4-35B Report Adverse Event 435B.doc
4-35C Report Violation / Non-Compliance 435C.doc
4-39A Final Report PI 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 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.pdf 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

 

 IRC · Independent Review Consulting, Inc. 415.485.0717· Fax 415.485.0328 · info@irb-irc.com