Which is a minimum prerequisite that should be in place before choosing an EDC system?
Answer(s): A
Before selecting an Electronic Data Capture (EDC) system for a clinical trial, it is essential to have a clear understanding of the functional requirements. This serves as the minimum prerequisite to guide system selection, ensuring that the EDC solution aligns with the protocol needs, data workflow,security requirements, and regulatory compliance.According to the Good Clinical Data Management Practices (GCDMP, Chapter: Computerized Systems and Compliance), functional requirements describe what the system must do--such as data entry capabilities, edit checks, query management, user roles, audit trails, and integration with external systems (e.g., labs, ePRO). This understanding allows sponsors and CROs to evaluate vendor systems effectively during the selection and qualification phase.Other options:B . Installation qualification and D. Validation plan occur after system selection. C . Governance documentation supports operations but is not required before choosing the system. Hence, option A is correct -- the first and most essential prerequisite before EDC selection is a solid understanding of the functional requirements.
(CCDM-Verified Sources)SCDM GCDMP, Chapter: Computerized Systems and Compliance, Section 4.2 Requirements Gathering and System SelectionFDA 21 CFR Part 11 System Validation and Intended Use Requirements ICH E6(R2) GCP, Section 5.5.3 Computerized System Selection and Qualification
The result set from the query below would be which of the following? SELECT Pt_ID, MRN, SSN FROM patient
Answer(s): D
In a SQL (Structured Query Language) database, the SELECT statement specifies which columns to display from a table. In this query, only three columns -- Pt_ID, MRN, and SSN -- are being selected from the patient table.This means the resulting dataset will contain:The same number of rows (records) as the original table (assuming no WHERE filter), and Fewer columns than the full table.In database terminology:"Wider" refers to more columns (fields)."Narrower" refers to fewer columns (fields).Since this query retrieves only 3 columns (out of potentially many in the original table), the result set is narrower than the patient table, making option D correct.
(CCDM-Verified Sources)SCDM GCDMP, Chapter: Database Design and Build, Section 5.1 Relational Databases and Query LogicICH E6(R2) GCP, Section 5.5.3 Data Retrieval and Integrity PrinciplesFDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.4 Database Query Controls
What are the first logical specifications that need approval when building an efficient EDC database?
In the EDC database build process, the first logical specifications that require approval are the electronic Case Report Form (eCRF) fields.According to the Good Clinical Data Management Practices (GCDMP, Chapter: Database Design and Build), eCRF field specifications define what data elements are collected, their data types, permitted values, field lengths, and any associated metadata. Approval of these specifications forms the foundation for subsequent design components such as edit check programming, query management rules, and data validation logic.Edit checks (B) are developed only after fields and structures are finalized. Metric reports (C) and eCRF guidelines (D) are downstream documentation or tools, not logical specifications required at the build start.Therefore, option A (eCRF fields) is correct, as their approval marks the first formal milestone in the EDC system development life cycle.
(CCDM-Verified Sources)SCDM GCDMP, Chapter: Database Design and Build, Section 4.2 Logical Design and eCRF Field SpecificationsICH E6(R2) GCP, Section 5.5.3 System Design and Validation Documentation FDA 21 CFR Part 11 System Validation and Documentation Controls
Which of the following roles commonly requires data entry and update privileges in an EDC application used in a clinical study?
In an EDC system, Site Study Coordinators are typically responsible for data entry and updates, as they are the site-level personnel who record subject data from source documents into the electronic CRFs (eCRFs).The Good Clinical Data Management Practices (GCDMP, Chapter: EDC Systems) outlines that data entry and modification privileges should only be granted to qualified site personnel who have completed EDC system training and are listed on the study delegation log. These users directly handle patient-level data entry and correction.In contrast:Clinical Study Monitors (B) review and verify data but do not enter or modify it. EDC System Administrators (C) manage user access and configuration settings, not study data. Study Statisticians (D) work with extracted, cleaned datasets but never have data modification privileges.Thus, option A (Site Study Coordinator) correctly identifies the role with authorized data entry and update privileges.
(CCDM-Verified Sources)SCDM GCDMP, Chapter: Electronic Data Capture (EDC) Systems, Section 5.2 User Roles and Access PermissionsICH E6(R2) GCP, Section 4.1 Investigator Responsibilities for Data Accuracy FDA 21 CFR Part 11 User Access and Accountability in Electronic Systems
When reviewing local lab data from a paper study, a Data Manager notices there are lab values not entered. What should the Data Manager request data-entry personnel do?
Answer(s): C
When laboratory data are missing from a paper-based clinical study, the Data Manager should direct data-entry personnel to issue a query to the investigative site for clarification or correction. According to the Good Clinical Data Management Practices (GCDMP, Chapter: Data Validation and Cleaning), every missing, inconsistent, or out-of-range data point must be reviewed and, if necessary, resolved through the formal query management process. This ensures that all discrepancies between the source documents and database entries are properly documented, traceable, and auditable.Data-entry staff are not authorized to infer or fill in missing information. They must escalate such discrepancies to the site via query, preserving data integrity and regulatory compliance with ICH E6 (R2) and FDA 21 CFR Part 11. Calling the patient directly (option B) would violate confidentiality and site communication protocol, while simply flagging or ignoring the issue (options A and D) would not meet GCDMP query resolution standards.
(CCDM-Verified Sources)SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Validation and Cleaning, Section 5.2 Query Management and ResolutionICH E6 (R2) Good Clinical Practice, Section 5.18.4 Communication of Data Discrepancies FDA 21 CFR Part 11 Electronic Records; Query Audit Trails Requirements
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