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
Which section of a Clinical Trial Agreement typically addresses indemnification?
Answer: Liabilities, Indemnification, and Insurance
The indemnification clause specifies which party bears financial responsibility for claims arising from the trial, protecting investigators from sponsor negligence and vice versa.
What is a 'work order' (or task order) in the context of CRO management?
Answer: A document that activates specific services under a Master Service Agreement
A work order (task order) is issued under an existing MSA to authorize and define the scope, timeline, and cost of a specific service the CRO will provide.
What is the primary role of a Master Service Agreement (MSA) in clinical research vendor management?
Answer: To establish standard terms and conditions governing all future work with a vendor
An MSA sets overarching legal and operational terms (confidentiality, liability, payment) that apply to all subsequent work orders with that vendor, streamlining contracting.
When should a Clinical Research Manager escalate a contract dispute with a CRO to senior management?
Answer: When direct resolution attempts fail and the dispute risks study timelines or compliance
Escalation to senior management is warranted when direct negotiation fails and the unresolved dispute threatens study integrity, timelines, or regulatory compliance.
What does the 'force majeure' clause in a clinical trial contract provide?
Answer: Relief from contractual obligations when performance is prevented by unforeseeable extraordinary events
Force majeure clauses excuse a party from performance when extraordinary, unforeseeable events (e.g., natural disasters, pandemics) make fulfillment impossible.
What is the purpose of an 'audit right' provision in a clinical trial contract?
Answer: To grant the sponsor or regulatory authority the right to inspect vendor records for compliance verification
An audit right clause gives the sponsor (and sometimes regulators) contractual authority to inspect a vendor's records, systems, and processes to verify GCP and protocol compliance.