EDC & CDMS Systems Flashcards
7 cards from real CRA practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 EDC & CDMS Systems flashcards as text
What is the significance of an electronic signature in an EDC system, per 21 CFR Part 11?
Answer: It is legally binding and equivalent to a handwritten signature when the system meets all Part 11 requirements
Under 21 CFR Part 11, electronic signatures carry the same legal weight as handwritten signatures, provided the system meets all specified security and audit requirements.
A sponsor decides to add a new data field to the EDC mid-study. What process must be followed?
Answer: A formal change control process must be initiated, including documentation, testing in the validation environment, and UAT before deployment
All EDC changes during a live study require formal change control: documenting the reason, testing in a non-production environment, UAT, and approval before deploying to the live system.
What does 'data migration' refer to in a CDMS context?
Answer: The process of transferring data from one system or format to another, such as from a legacy database to a new EDC platform
Data migration involves moving existing data from one system (e.g., an old EDC or paper database) to a new system, requiring validation to confirm data integrity throughout the transfer.
In an EDC system, what is a 'visit schedule' (or visit matrix)?
Answer: A structured framework that defines which forms and data fields are applicable at each protocol-specified study visit
The visit schedule (or matrix) maps each protocol-required visit to the specific eCRF forms and data fields that must be completed at that timepoint.
When a CRA conducts source data verification (SDV) using an EDC system, what is being compared?
Answer: Data entered in the eCRF against the original source documents at the site (e.g., medical records, lab reports)
SDV is the process of checking that data recorded in the eCRF exactly matches the original source data from which it was transcribed, confirming accuracy and completeness.
What is the primary purpose of a Data Management Plan (DMP) in a clinical trial?
Answer: To describe all data management processes, responsibilities, systems, and timelines for handling clinical trial data from collection to archiving
The DMP is a comprehensive document that outlines how data will be collected, validated, cleaned, stored, and archived throughout the study, defining roles and responsibilities for data management activities.
Which of the following actions would be considered a data integrity violation in an EDC system?
Answer: A site coordinator logging in under a colleague's credentials to enter data when the colleague is unavailable
Using another person's credentials in an EDC is a serious data integrity violation because it makes the audit trail attribute that individual's actions to the wrong person.