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
What is the purpose of a 'data management plan' (DMP) in a clinical trial?
Answer: To document roles, responsibilities, processes, and tools for collecting, managing, and delivering trial data
A DMP is a living document that defines how data will be collected, managed, cleaned, and delivered, serving as the operational blueprint for the data management team.
A site reports that a subject's eCRF was completed by an unauthorized study staff member. Under GCP, what action is required?
Answer: Document the protocol deviation, assess data reliability, and implement corrective and preventive action (CAPA)
Unauthorized data entry is a GCP deviation requiring documentation, a data reliability assessment, and a formal CAPA to prevent recurrence.
In a multi-regional clinical trial, a site in Europe collects dates in DD/MM/YYYY format while the central database uses MM/DD/YYYY. What is the best data management solution?
Answer: Implement an automatic date format conversion at the point of data entry in the EDC with validation
Building automatic format conversion with validation into the EDC at data entry prevents errors at the source and avoids time-consuming manual corrections.
What is the key distinction between 'source data' and 'source documents' in clinical research?
Answer: Source data is the actual information collected; source documents are the media on which source data is first recorded
ICH E6(R2) defines source data as the information itself and source documents as the files, records, or data where that information is first captured, whether paper or electronic.
A data manager identifies a systematic error in an edit check that caused valid values to be flagged as errors across all sites. What is the most appropriate response?
Answer: Initiate a validated change control process to correct the edit check, reprocess affected records, and document all actions
Systematic edit check errors require a formal change control process to ensure the fix is validated, all affected records are reprocessed, and the change is fully documented for regulatory audit.
When performing reconciliation of SAE data between the safety database and the clinical database, what outcome confirms successful reconciliation?
Answer: All SAEs present in one database are present in the other with consistent key fields such as subject ID, event term, start date, and outcome
Successful SAE reconciliation requires that every event appears in both databases with consistent identifying and descriptive fields, not merely matching counts.
What is the primary reason clinical trials require a 'protocol deviation log' maintained by the data management team?
Answer: To provide a complete record of departures from the approved protocol for regulatory inspection and data integrity assessment
A protocol deviation log ensures regulators can assess the nature and impact of deviations on data integrity and subject safety during inspections, fulfilling GCP documentation requirements.