Electronic Data Capture 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 Electronic Data Capture flashcards as text
What is the purpose of a 'data transfer agreement' between an EDC vendor and a clinical trial sponsor?
Answer: To specify responsibilities, data ownership, security requirements, and data handling procedures between parties
A data transfer agreement defines the legal and operational terms governing how data is shared, stored, and protected between the sponsor and EDC vendor.
In EDC system design, what is the purpose of implementing 'field-level permissions' for different user roles?
Answer: To restrict data entry, viewing, or modification rights to only those authorized for specific fields
Field-level permissions ensure that users can only interact with data fields appropriate to their role, preventing unauthorized access or modification.
Which CDISC standard defines the format for exchanging clinical data between different EDC systems and other clinical trial software?
Answer: ODM (Operational Data Model)
The CDISC ODM (Operational Data Model) is an XML-based standard that defines the format for transporting and archiving clinical data between different systems.
A clinical data manager is reviewing the Data Management Plan (DMP). Which section should specifically address how EDC system discrepancies between programmed edit checks and source data will be handled?
Answer: Query management and resolution procedures
The query management section of the DMP describes the process for generating, routing, tracking, and resolving data discrepancies identified by the EDC system.
When building an eCRF, the data manager maps each field to a CDASH variable. What is the primary benefit of CDASH-compliant eCRF design?
Answer: It streamlines the path from data collection to SDTM submission by aligning collection with regulatory standards from the start
CDASH-aligned eCRFs collect data in a format that maps more directly to SDTM, reducing the transformation effort needed for regulatory submissions.
Which scenario best describes a 'protocol deviation' that would be captured in an EDC system?
Answer: A subject misses a required study visit that falls within the protocol-specified window
A missed required visit that violates the protocol-specified window is a protocol deviation and must be documented in the EDC system.
In an EDC system supporting an adaptive trial design, which feature is most critical to maintain trial integrity when interim analyses trigger design modifications?
Answer: Strict access controls and blinding protections that prevent unauthorized users from seeing interim results
In adaptive trials, strict blinding controls in the EDC prevent unblinded interim results from being seen by parties who could introduce bias into ongoing data collection.