SCDM Certified Clinical Data Manager CCDM Exam Dumps: Updated Questions & Answers (October 2025)

When a new version ofMedDRA (Medical Dictionary for Regulatory Activities)is released, the correct action is toevaluate the extent and impact of the changesbefore implementation.

According to theGCDMP (Chapter: Medical Coding and Dictionaries), MedDRA updates are published twice yearly (March and September). Each release may introduce new terms, modify hierarchies, or retire old ones. Prior to adopting a new version, theData ManagerandMedical Codermust:

Assess the number and type of term changes,

Determine the potential effect on ongoing coding consistency, and

Decide whether migration to the new version is warranted mid-study or deferred until database lock.

Immediate recoding (option C) without evaluation may cause inconsistencies and require additional validation. Continuing with the existing version (option B) may be acceptable short-term but must be justified. Using an alternative dictionary (option D) is noncompliant, as MedDRA is the regulatory standard for safety reporting.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Medical Coding and Dictionaries, Section 6.3 – Version Control and Impact Assessment

MedDRA Term Selection: Points to Consider (MSSO, Latest Version), Section 3 – Versioning and Maintenance

ICH E2B(R3) – Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports

Enrolling subjects before theElectronic Data Capture (EDC) systemis ready poses majordata integrity and compliance risks. The primary issue is thatdata cannot be accurately captured, validated, or monitoredwithout the system in place.

Per theGCDMP (Chapter: Data Management Planning and Study Start-up), data collection systems must befully validated, tested, and releasedbefore enrollment begins to ensure:

Real-time data entry and quality control

Proper tracking of adverse events (AEs/SAEs)

Audit trails and traceability for regulatory compliance

Option A highlights the most critical consequence — without an operational EDC, data collection and verification processes cannot occur, compromising data quality and study oversight.

While options B, C, and D may be partially true, they aresecondary effects. The fundamental consideration is data capture capability and monitoring control, makingoption Acorrect.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Data Management Planning and Study Start-up, Section 4.2 – EDC Readiness and System Validation

ICH E6(R2) GCP, Section 5.5.3 – Computerized Systems Validation Before Use

FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6.1 – System Qualification Prior to Data Entry

Whenmerging data from different clinical trials, theuse of a common adverse event (AE) dictionary(such asMedDRAorWHO Drug) is essential to ensure consistency and comparability across datasets.

According to theGCDMP (Chapter: Standards and Data Mapping)andCDISC SDTM Implementation Guide, data integration across studies requires standardized terminology for adverse events, medications, and clinical outcomes. Using the same AE dictionary ensures that similar terms are coded consistently, allowing accurate cross-study analysis, pooled summaries, and safety reporting.

A sharedsoftware platform (option A)is not necessary if data are mapped to standard formats (e.g., CDISC SDTM). Patient population similarity (option B) affects interpretation but not technical data merging. Study design differences (option C) may influence statistical analysis but not data integration mechanics.

Therefore,Option D – Use of a common adverse event dictionary– is the correct and most critical action for consistent multi-study data integration.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Standards and Data Mapping, Section 5.1 – Use of Standardized Coding Dictionaries

CDISC SDTM Implementation Guide, Section 4.3 – Controlled Terminology and Cross-Study Integration

ICH E3 and E2B – Clinical Data Standards and Safety Coding Requirements

In studies where themedical record serves as the source document, theElectronic Data Capture (EDC)system users (typically study coordinators or site personnel) must have appropriatetraining on how to access and log into the medical record system. This competency ensures that data abstracted from the electronic medical record (EMR) are complete, accurate, and verifiable in compliance with Good Clinical Practice (GCP) andGood Clinical Data Management Practices (GCDMP).

According to theGCDMP (Chapter: EDC Systems and Data Capture)andICH E6(R2), all personnel involved in data entry and verification must be trained in both the EDC and the primary source systems (e.g., EMR). This ensures that the integrity of data flow—from source to EDC—is maintained, and that personnel understand system access controls, audit trails, and proper documentation of source verification.

Whileresolving discrepant data (C)andscreening subjects (A)are part of study operations, thecompetency directly related to EDC system use in EMR-based studiesis the ability to properly log into and navigate the medical records system to extract source data.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Electronic Data Capture (EDC), Section 5.1 – Source Data and System Access Requirements

ICH E6(R2) Good Clinical Practice, Section 4.9 – Source Documents and Data Handling

FDA Guidance: Use of Electronic Health Record Data in Clinical Investigations, Section 3 – Investigator Responsibilities

During amajor system upgrade, it is critical to verify thatarchived data remain accessible, readable, and intactfollowing the implementation.

According to theGCDMP (Chapter: Database Lock and Archiving), regulatory requirements such as21 CFR Part 11andICH E6(R2)mandate that archived data must remain retrievable in ahuman-readable formatfor the duration of retention (often years after study completion).

Therefore, as part ofvalidation and verification testing, organizations must confirm that existing archives can still be accessed using the upgraded system or compatible tools.

Option A:Updating archive formats could alter original data integrity (noncompliant).

Option C:Migration offsite is an IT infrastructure task, not directly tied to the upgrade process.

Option D:Comparing CRFs to archives is unnecessary unless data corruption is suspected.

Hence,option B (testing archive accessibility)is the correct and compliant approach.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Database Lock and Archiving, Section 5.4 – System Upgrades and Archive Validation

ICH E6(R2) GCP, Section 5.5.3 – System Validation and Data Retention

FDA 21 CFR Part 11 – Data Archiving, Retention, and Retrieval Requirements

The section of theClinical Study Report (CSR)most useful for aData Manageris thedescription of how data were processed.

According to theGCDMP (Chapter: Data Quality Assurance and Control), this section details thedata handling methodology— includingdata cleaning, coding, transformation, and derivation procedures— all of which are core responsibilities of data management. Reviewing this section ensures that the data processing methods documented in the CSR align with theData Management Plan (DMP),Data Validation Plan (DVP), anddatabase specifications.

Thestatistical methods section (option A)is primarily for biostatistics, and therationale for study design (option B)pertains to clinical and regulatory affairs.Clinical narratives (option D)are used by medical reviewers, not data managers.

By reviewing how data were processed, the Data Manager verifies that the study data lifecycle—from collection to analysis—was conducted in compliance with regulatory and GCDMP standards.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: Data Quality Assurance and Control, Section 6.3 – Documentation of Data Processing in Clinical Study Reports

ICH E3 – Structure and Content of Clinical Study Reports, Section 11.3 – Data Handling and Processing

FDA Guidance for Industry: Clinical Study Reports and Data Submission – Data Traceability and Handling Documentation

Blood pressure is aquantitative physiological measurement, typically consisting oftwo continuous numeric values: systolic and diastolic pressure. Therefore, the most appropriate and scientifically valid method of data collection is to usetwo continuous variables(e.g., systolic = 120 mmHg, diastolic = 80 mmHg).

According to theGCDMP (Chapter: CRF Design and Data Collection), data fields must be designed to capture the mostprecise, accurate, and analyzableform of clinical data. Numeric data should be collected using numeric data types to allow for range checks, calculations (e.g., mean arterial pressure), and statistical analysis.

Options such as categorical representations (radio buttons or check boxes) introduce rounding, data loss, and analytic limitations. Coding a verbatim diagnosis (option A) is inappropriate for numeric vital sign data and violates the principle of capturing data at the most granular level.

Thus, the correct and validated method per CCDM standards istwo continuous variables, ensuring accuracy, traceability, and analytical flexibility.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: CRF Design and Data Collection, Section 4.2 – Best Practices for Quantitative Data Capture

ICH E6 (R2) Good Clinical Practice, Section 5.5.3 – Data Accuracy and Collection Standards

FDA Guidance for Industry: Electronic Source Data in Clinical Investigations, Section 4.3 – Data Format and Structure Requirements

Although clerical staff can technically perform data entry,data entry in clinical research requires study-specific training, particularly in the use of theElectronic Data Capture (EDC) systemand understandingdata discrepancy resolutionprocedures.

According to theGood Clinical Data Management Practices (GCDMP, Chapter: CRF Design and Data Collection)andICH E6 (R2), individuals responsible for data entry at clinical sites must bequalified by education, training, and experience. This includes understanding how to navigate the EDC system, enter data according to CRF Completion Guidelines, and appropriately respond to queries or system-generated edit checks.

Untrained clerical personnel may inadvertently introduce errors, violate Good Clinical Practice (GCP) standards, or fail to recognize protocol-relevant data. Therefore, theData Managermust ensure that site users receivestudy-specific and system trainingbefore gaining access to the EDC environment.

Reference (CCDM-Verified Sources):

SCDM Good Clinical Data Management Practices (GCDMP), Chapter: CRF Design and Data Collection, Section 5.2 – Investigator Site Training and Data Entry Requirements

ICH E6 (R2) Good Clinical Practice, Section 4.1.5 – Qualified Personnel and Training Requirements

FDA 21 CFR Part 11 – User Access and Training Provisions for Electronic Records

Let’s calculate the workload:

200 patients × 30 minutes = 6,000 minutes/week

6,000 minutes ÷ 60 =100 hours/week

Over 6 months (~26 weeks): 100 × 26 =2,600 hours total

Assuming a full-time Data Manager works approximately160 hours/month, over6 months (960 hours)per full-time equivalent (FTE):

2,600 ÷ 960 ≈2.7 FTEs total for the entire study period

To find theaverage per month, we divide evenly over 6 months:

2.7 ÷ 6 ≈0.45 FTE per month, or approximately50% of a Data Manager per month.

Thus, the correct answer isB. Fifty percent of a Data Manager per month.

This estimate follows GCDMP best practices inresource planning, ensuring adequate data management capacity for ongoing external data handling activities.

Reference (CCDM-Verified Sources):

SCDM GCDMP, Chapter: Project Management, Section 5.3 – Resource Estimation and Workload Planning

ICH E6(R2) GCP, Section 5.1.1 – Quality Systems and Adequate Staffing

During a regulatory inspection, inspectors expect to find documentedStandard Operating Procedures (SOPs)governing the use, validation, and maintenance ofcomputerized systems, includingdata backup and recovery procedures.

According to theGCDMP (Chapter: Computerized Systems and Compliance)andFDA 21 CFR Part 11, organizations must maintain an SOP that ensuresdata 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 theData Management Plan (A)andEdit Specifications (D)are study-level documents, and theStatistical Analysis Plan (C)focuses on analysis procedures,only a Data Backup Plan (B)constitutes a requiredsystem-level SOPensuring 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