Data Validation 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 Data Validation flashcards as text
Which process involves reconciling adverse event data between the clinical database and the safety database to ensure consistency?
Answer: SAE reconciliation
SAE reconciliation is the formal process of comparing serious adverse event records between the clinical database and the pharmacovigilance safety database to identify and resolve discrepancies.
What is the significance of a 'validation summary report' at the close of database build activities?
Answer: It documents that the database and edit checks were tested and function as specified
A validation summary report formally documents the testing performed, results obtained, and confirmation that the clinical database system meets its predefined specifications.
A sponsor implements a rule that no more than 20% of data fields in any CRF page can be missing at the time of database lock. This is an example of which concept?
Answer: Data quality threshold
A data quality threshold is a predefined acceptable limit for data completeness, accuracy, or consistency that a dataset must meet to be considered acceptable for analysis.
During a clinical trial, lab values are received electronically from a central lab. Which validation step should be performed first upon receipt of this data transfer?
Answer: Verify the integrity and completeness of the transfer file against a manifest or reconciliation report
Before processing external data transfers, data managers must verify file integrity and completeness against a transfer manifest to ensure no records were lost or corrupted during transmission.
What is the role of the Data Validation Plan (DVP) within the broader Data Management Plan (DMP)?
Answer: It specifies the approach, scope, and methodology for validating the clinical database and data
The Data Validation Plan details the specific strategy, types of checks, responsibilities, and acceptance criteria for ensuring data quality throughout the trial.
Which term describes a validation check that confirms each subject has only one unique randomization number assigned within the study?
Answer: Uniqueness check
A uniqueness check verifies that a value expected to be unique, such as a randomization number or subject ID, appears only once within the dataset.
In the context of CCDM exam preparation, what does '100% source data verification' mean, and why is it increasingly questioned under modern guidelines?
Answer: It means checking every data point against source documents, and ICH E6(R2) encourages a risk-based approach instead
100% SDV was historically standard but ICH E6(R2) promotes risk-based monitoring, focusing SDV resources on critical and high-risk data points rather than every field.