CRM CRM Budget & Contract Management

Question 1

What is the primary purpose of a Clinical Trial Agreement (CTA) budget?

Accepted Answer

To define payment terms and reimbursable costs between sponsor and investigative site

Answer

A CTA budget defines the financial arrangement between the sponsor and site, including payments for procedures, staff time, and pass-through costs.

Question 2

Which cost category typically represents the largest portion of a clinical trial budget?

Accepted Answer

Site and patient-related costs including procedures and staff

Answer

Site and patient-related costs — including clinical procedures, coordinator time, and patient reimbursements — usually account for the largest share of a trial budget.

Question 3

What is a 'pass-through' cost in clinical trial budgeting?

Accepted Answer

An expense incurred by the CRO that is billed directly to the sponsor at cost

Answer

Pass-through costs are expenses (e.g., lab kits, couriers) that a CRO or site incurs and bills to the sponsor at actual cost without markup.

Question 4

How should a Clinical Research Manager handle a budget deviation identified mid-trial?

Accepted Answer

Document the deviation, notify the sponsor, and initiate a budget amendment if needed

Answer

Budget deviations must be promptly documented and communicated to the sponsor; a formal amendment is required if the scope of work has changed.

Question 5

What is the purpose of a milestone payment structure in a clinical trial agreement?

Accepted Answer

To tie sponsor payments to the achievement of specific study deliverables

Answer

Milestone payments align financial incentives with study progress by releasing funds only when agreed deliverables (e.g., first patient enrolled, database lock) are achieved.

CRM - Clinical Research Manager Certification Practice Test

CRM - Clinical Research Manager Certification Practice Test

CRM CRM Budget & Contract Management