Clinical Data Collection & Management Flashcards
7 cards from real CCDM practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Clinical Data Collection & Management flashcards as text
During database lock preparation, a discrepancy is found between the randomization code list and the study database. What should the data manager do first?
Answer: Place the database on hold and investigate the discrepancy before locking
The database must not be locked until all discrepancies between source randomization data and the database are resolved to ensure data integrity and regulatory compliance.
Which type of data validation check would catch a subject age recorded as 250 years?
Answer: Range check
A range check flags values outside predefined minimum and maximum limits, such as an impossible age of 250 years.
A sponsor decides to transition from paper CRFs to an EDC system mid-study. What is the most critical data management consideration?
Answer: Ensuring a validated migration plan that maintains data integrity and provides a clear audit trail
A validated migration plan is essential to ensure that existing data is accurately transferred to the EDC system and that the audit trail remains intact.
What is the primary function of a 'data monitoring committee' (DMC) in a clinical trial?
Answer: To independently review accumulating safety and efficacy data and recommend trial continuation, modification, or termination
A DMC independently monitors unblinded interim data to protect participant safety and study integrity, with authority to recommend changes to the trial conduct.
Under 21 CFR Part 11, which of the following is required for electronic signatures used in clinical research?
Answer: A unique combination of identification code and password with binding documentation linking the signature to the record
21 CFR Part 11 requires electronic signatures to be uniquely linked to the signer via credentials, and the organization must have documentation binding the electronic signature to the individual.
A CRF page contains a field for 'date of last menstrual period' in a trial that includes both male and female subjects. What validation rule should be applied?
Answer: The field should be conditionally required only for female subjects
Conditional logic in the CRF should make sex-specific fields required only when applicable, reducing unnecessary missing data queries for male subjects.
What is the main advantage of using a centralized data management model versus a decentralized model?
Answer: Standardized processes and tools reduce variability across sites and improve data consistency
Centralized data management enforces uniform standards, edit checks, and processes across all sites, leading to more consistent and higher-quality data.