CRM Budget & Contract Management Flashcards
6 cards from real CRM practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 CRM Budget & Contract Management flashcards as text
What is the primary purpose of a Clinical Trial Agreement (CTA) budget?
Answer: To define payment terms and reimbursable costs between sponsor and investigative site
A CTA budget defines the financial arrangement between the sponsor and site, including payments for procedures, staff time, and pass-through costs.
Which cost category typically represents the largest portion of a clinical trial budget?
Answer: Site and patient-related costs including procedures and staff
Site and patient-related costs — including clinical procedures, coordinator time, and patient reimbursements — usually account for the largest share of a trial budget.
What is a 'pass-through' cost in clinical trial budgeting?
Answer: An expense incurred by the CRO that is billed directly to the sponsor at cost
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.
How should a Clinical Research Manager handle a budget deviation identified mid-trial?
Answer: Document the deviation, notify the sponsor, and initiate a budget amendment if needed
Budget deviations must be promptly documented and communicated to the sponsor; a formal amendment is required if the scope of work has changed.
What is the purpose of a milestone payment structure in a clinical trial agreement?
Answer: To tie sponsor payments to the achievement of specific study deliverables
Milestone payments align financial incentives with study progress by releasing funds only when agreed deliverables (e.g., first patient enrolled, database lock) are achieved.
Which document formally establishes the payment terms between a sponsor and an investigative site?
Answer: The Clinical Trial Agreement
The Clinical Trial Agreement is the legally binding contract that, among other provisions, specifies payment schedules, reimbursable costs, and financial obligations.