Quality Control & Regulatory Compliance 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 Quality Control & Regulatory Compliance flashcards as text
An IRB-approved protocol is amended mid-study to add a new secondary endpoint. From a data management QC perspective, which action is MOST important?
Answer: Assess the impact on existing eCRF design, edit checks, and data management plan, and document changes
A protocol amendment requires an impact assessment to determine which data management components (eCRF, edit checks, DMP) must be updated, and all changes must be documented to maintain a clear audit trail.
In the context of CCDM, 'data traceability' most accurately refers to:
Answer: The ability to trace any data point back to its original source document and forward to its final analysis dataset
Data traceability means any value in an analysis dataset can be traced back to the source document and any source data can be traced forward through all transformations to its final analysis representation.
A site submits a query response stating 'data confirmed as entered' without providing source documentation. What is the appropriate CDM response?
Answer: Escalate the query and request source documentation to verify the data against original records
A 'data confirmed' response without source documentation is insufficient; the CDM team must request source documentation to verify the data against original records per GCP requirements.
Which ICH guideline specifically addresses the structure and content of clinical study reports (CSRs), including data quality documentation requirements?
Answer: ICH E3
ICH E3 provides guidelines on the structure and content of clinical study reports, including requirements for documenting data quality, protocol deviations, and analysis populations.
When performing a go/no-go assessment for database lock, the data management team discovers that 2% of critical efficacy fields remain unanswered after final query. Which action is MOST appropriate?
Answer: Document the missing data, assess its potential impact on the primary analysis, and determine if imputation is required per the SAP
Missing critical data must be documented, its impact on the primary analysis assessed, and handling (including imputation) should follow pre-specified procedures in the Statistical Analysis Plan.
Under 21 CFR Part 312.62, sponsors are required to maintain records of which of the following for each study subject?
Answer: Case histories and disposition of the investigational drug, including records of drug accountability
21 CFR Part 312.62 requires investigators to maintain case histories for each subject and adequate records of the disposition of investigational drugs, including drug accountability records.
A clinical data manager is designing QC checks for a lab data reconciliation between the central lab and the eCRF. Which scenario MOST warrants a critical query?
Answer: A Grade 3 abnormal lab value present in the central lab feed that is absent from the eCRF
A Grade 3 (severe) abnormal lab value present in the lab feed but missing from the eCRF is a critical safety data discrepancy that could affect subject safety reporting and regulatory compliance.