Question 1
During study start-up, a data manager selects a CDISC standard to govern how data fields are captured on the eCRF. Which standard is designed specifically for this data collection stage?
Show answer & explanation
Correct answer: C - CDASH
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These 10 free CCDM questions are organized by exam domain, so you can see how each part of the Certified Clinical Data Manager blueprint is tested. Reveal the answer and explanation under each question.
During study start-up, a data manager selects a CDISC standard to govern how data fields are captured on the eCRF. Which standard is designed specifically for this data collection stage?
Correct answer: C - CDASH
A sponsor asks the data manager to document, for one specific trial, how data will be collected, cleaned, coded, reconciled, and locked. Which document should the data manager produce?
Correct answer: C - A Data Management Plan (DMP)
An edit check fires because a reported medication stop date is earlier than its start date. This check is BEST classified as which type?
Correct answer: A - A cross-field consistency check
A biostatistician needs analysis-ready datasets built from the tabulated study data. Which CDISC standard defines these datasets?
Correct answer: C - ADaM
A data manager marks up a blank CRF with the corresponding database and submission variable names for each field. What is the PRIMARY purpose of this annotated CRF?
Correct answer: A - To link each CRF field to its dataset variable for programming and review
In a clinical study database, adverse events coded in MedDRA are most commonly summarized and reported at which term level?
Correct answer: B - Preferred Term (PT)
When an investigator's verbatim adverse-event term is entered, it is matched to the MedDRA level that most closely represents the exact wording used. Which level is this?
Correct answer: D - Lowest Level Term (LLT)
A study is scheduled to begin enrollment in 2021. To meet FDA submission requirements, concomitant medications coded with WHODrug must use which dictionary format?
Correct answer: C - The B3 format
Before database lock, a data manager compares serious adverse event records held in the clinical (EDC) database against those in the safety/pharmacovigilance database. What is the PRIMARY purpose of this activity?
Correct answer: D - To confirm the two systems agree on the events and their key details
An automated edit check flags a laboratory value that is biologically implausible. The site has not yet been contacted. According to the standard query workflow, what should happen NEXT?
Correct answer: B - Issue a query to the site to investigate and respond
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