Consistency Review-Checklist

Required by Clinical Trials Billing, Monitoring & Auditing Policy (#2335.0)

Date: / /	Type of Study:	Multi-Specialty	CCOP

Study SP Code or Protocol #:

Study PI:

Abbreviated Study Title:

ITEMS NEEDED TO CONDUCT REVIEW:

Institutional Certification Form for IRB Deferred Studies

IRB application

Protocol

Proposed final consent form

Proposed final contract (only needed for Injury Compensation Language) or N/A, no contract

- Check binder for “Master Agreement”; check annually for updates (with legal or CRC)

Billing plan/MCA (final) - CRC use only

I. SUBJECT PAYMENT LANGUAGE: (match Consent, Application, & Billing Plan)

Consent: See Page(s) /Section(s):

IRB App: See Page(s) /Section(s):

Billing Plan: Reference Section(s):

The consent form contains specific language about subject payment responsibilities (e.g., all costs of

the study are covered with the exception of the Year 2 physical exam which will be billed to your or your

insurance company) and this information agrees w/information in the IRB application.

ORIP secondary verification

Subject payment language in consent form is consistent w/language in billing plan/MCA.

(Begin w/code chart on billing form; see codes for billing to patient or 3rd party. Ensure consistency w/the billing form, the IRB Application, and the Consent Form.)

CRC secondary verification (ORIP does not review)

Points of Clarification:

II. INJURY COMPENSATION LANGUAGE: (match intent of Contract & Consent)

Consent: See Page(s) /Section(s):

No Contract:

Consent form must include language stating 1) subject is responsible for cost; and 2) facility has no plans to compensate them.

ORIP secondary verification

Contract: (check all that apply)

Study-specific	See Page(s) / Section(s):

Master	See Page(s) / Section(s):

Intent of injury compensation language in the consent form is consistent with that in sponsor contract.

Match intent between documents and ensure patient/ their insurance isn’t billed for injury	treatment 1st. RE: Per legal dept policy & “Medicare 2nd Payer Rule” – Medicare is the “Payer of	Last Resort.” Therefore, we cannot bill them 1st when a sponsor will pay for injury treatment (or	other services/drug/treatment).

ORIP secondary verification

Points of Clarification:

III. SUBJECT STIPEND &/or TRAVEL REIMBURSEMENTS: (match Consent, IRB Application – usually

sect 2 #6; & Billing Plan)

Consent: See Page(s) /Section(s):

IRB App: See Page(s) /Section(s):

Billing Plan: Reference Section(s):

Subject stipend or travel reimbursement noted in the billing plan agrees with language	contained within the consent form and application.

CRC secondary verification (ORIP does not review)

Points of Clarification:

General Comments:

_____________________________________________	/ /

Reviewer Signature (CRC)	Date

_____________________________________________	/ /

Reviewer Signature (ORIP)	Date

Attached Documentation

Submit 1 copy of this completed form to ORIP along with the contract and IRB application material.

Version 01/21/14

Consistency Review-Checklist	Page 2 of 2

Consistency Review Checklist

Jaros, Linda M.

2014-01-21

Musson, Amanda C

Marshfield Clinic