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 document that defines which sponsor obligations have been transferred to a CRO?
Answer: The Functional Responsibility Transfer Document (or Sponsor-CRO Agreement appendix)
Per ICH E6(R2), a written agreement must clearly delineate which sponsor duties are transferred to the CRO; this is typically captured in the sponsor-CRO contract appendix or responsibility matrix.
What is the purpose of a vendor qualification audit in clinical research?
Answer: To verify that a vendor's systems, processes, and facilities meet GCP and regulatory requirements before engagement
A vendor qualification audit assesses whether a prospective vendor's quality systems, SOPs, and infrastructure are capable of meeting regulatory and study requirements before work begins.
How should a CRM address a CRO that consistently misses key deliverable deadlines?
Answer: Issue a formal written notice of default, document the pattern, and invoke corrective action provisions in the contract
Consistent underperformance should be addressed through formal written notices and contract corrective action provisions, with documentation to support escalation or termination if needed.
What is the 'functional service provider' (FSP) model in clinical research outsourcing?
Answer: Contracting a vendor to provide specific functional expertise (e.g., data management) embedded within the sponsor's team
The FSP model involves outsourcing a single function (e.g., biostatistics, monitoring) to a specialized vendor whose staff work as an extension of the sponsor's team.
Which key performance indicator (KPI) is most relevant for monitoring CRO data management performance?
Answer: Query resolution rate and time-to-database-lock
Query resolution rate and time-to-database-lock directly measure how efficiently the CRO is cleaning and finalizing study data, which is the core deliverable for data management teams.
What must be thoroughly documented when a sponsor transfers monitoring obligations to a CRO?
Answer: The specific monitoring tasks transferred, quality expectations, reporting requirements, and sponsor oversight procedures
ICH E6(R2) requires that any transfer of sponsor duties to a CRO be documented in a written agreement detailing the scope, quality standards, and how the sponsor will maintain oversight.