SCDM CCDM Exam Questions

When designing or configuring data entry screens within an Electronic Data Capture (EDC) system, three critical components are required for each field:

Data Type -- Defines the nature of the data (e.g., text, numeric, date).

Prompt -- The label or question displayed to the user.

Response Format -- Specifies how the user enters or selects data (e.g., free text, drop-down, checkbox).

According to the GCDMP (Chapter: EDC Systems and Database Design), these three attributes form the logical data structure required to build and validate data entry interfaces. They ensure consistency in how information is captured, displayed, and validated during data entry.

While user roles (A) and help text (D) are system-level configurations, not field-level specifications, page numbers (C) relate to printed CRFs rather than digital data screens.

Therefore, option B (Data type, prompt, and response format) correctly identifies the essential information needed to define data entry screens.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: EDC Systems and Database Design, Section 4.3 -- Screen Design Specifications

CDISC CDASH Implementation Guide, Section 3.2 -- Data Field Attributes

ICH E6(R2) GCP, Section 5.5.3 -- Data Capture and Input Standards

During a regulatory inspection, inspectors expect to find documented Standard Operating Procedures (SOPs) governing the use, validation, and maintenance of computerized systems, including data backup and recovery procedures.

According to the GCDMP (Chapter: Computerized Systems and Compliance) and FDA 21 CFR Part 11, organizations must maintain an SOP that ensures data protection against loss, corruption, or unauthorized access. The SOP should describe backup frequency, secure storage, verification of backup integrity, and procedures for data restoration.

While the Data Management Plan (A) and Edit Specifications (D) are study-level documents, and the Statistical Analysis Plan (C) focuses on analysis procedures, only a Data Backup Plan (B) constitutes a required system-level SOP ensuring compliance and data continuity.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Computerized Systems and Compliance, Section 5.2 -- Data Security, Backup, and Recovery SOPs

FDA 21 CFR Part 11 -- Subpart B, Controls for Closed Systems

ICH E6(R2) GCP, Section 5.5.3 -- System Security, Data Backup, and Recovery Requirements

The efficacy endpoint of all-cause mortality at one year directly depends on the date of death for each subject, making Option D -- Date of death the required data element.

According to the GCDMP (Chapter: Clinical Trial Protocols and Data Planning) and ICH E3/E9 Guidelines, the primary efficacy analysis must be based on time-to-event data, particularly when the endpoint involves mortality or survival. The date of death allows accurate calculation of time from randomization to event, essential for survival analysis (e.g., Kaplan-Meier curves).

While cause of death (C) may be collected for safety or secondary analyses, all-cause mortality specifically includes any death regardless of cause. Drug levels (A) and coagulation times (B) may serve as pharmacodynamic or exploratory endpoints but do not directly measure mortality.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Management Planning and Protocol Review, Section 5.4 -- Defining Data Required for Endpoints

ICH E9 -- Statistical Principles for Clinical Trials, Section 2.3 -- Time-to-Event Endpoints

FDA Guidance for Industry: Clinical Trial Endpoints for Drug Development and Approval

When a CRF modification leads to a sudden increase in EDC queries, the most likely cause is an error or misconfiguration in the edit checks introduced during or after the change. Therefore, the first step should be to review the edit checks for correctness.

The GCDMP (Chapter: Database Design and Validation) emphasizes that any database or CRF modification should trigger retesting of affected validation rules. Incorrect logic, thresholds, or missing conditional statements in automated edit checks can cause false or redundant queries, leading to unnecessary data management burden and site frustration.

Manually handling edit checks (option A) or adding SDV (option B) does not address the root cause. Having monitors close queries (option D) would mask the problem rather than resolve it.

Thus, the correct corrective measure is Option C --- review and validate the edit checks to ensure proper functionality.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Database Design and Validation, Section 5.5 -- Edit Check Testing and Review

ICH E6 (R2) GCP, Section 5.5.3 -- Validation and Change Control for Electronic Systems

FDA 21 CFR Part 11 -- System Validation and Change Documentation

The correct action is to consult the CRO's Lead Data Manager and CRO's Project Leader (Option C) to ensure the issue is addressed through the appropriate oversight and escalation process.

According to the GCDMP (Chapter: Project Management and Communication), when a sponsor Data Manager identifies significant data management issues under CRO oversight --- such as aging queries or site performance disparities --- communication must follow the established governance and escalation pathway defined in the Scope of Work (SOW) and Data Management Plan (DMP).

Directly contacting the site (Option B) bypasses the CRO's chain of command and violates communication protocols. Notifying only the Clinical Leader (Option A) is insufficient, and ignoring the issue (Option D) jeopardizes the Data Safety Monitoring Board (DSMB) review timeline.

Therefore, Option C ensures a documented, collaborative approach to problem resolution within the contractual oversight structure.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Project Management and Communication, Section 7.1 -- Oversight of CRO Data Management Activities

ICH E6 (R2) GCP, Section 5.2 -- Contract Research Organization Responsibilities

FDA Guidance for Industry: Oversight of Clinical Investigations -- Sponsor and CRO Roles and Communication Pathways