[Feb 04, 2026] CCDM Free Exam Questions with Quality Guaranteed [Q78-Q101]

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[Feb 04, 2026] CCDM Free Exam Questions with Quality Guaranteed

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SCDM CCDM Exam Syllabus Topics:

Topic	Details
Topic 1	Review Tasks: This section measures the skills of Data Managers and involves reviewing protocols, CRFs, data tables, listings, figures, and clinical study reports (CSRs) for consistency, accuracy, and alignment with data handling definitions and regulatory requirements.
Topic 2	Design Tasks: This section of the CCDM exam measures skills of Data Managers and covers how to design and document data collection instruments, develop workflows and data flows, specify data elements, CRF forms, edit checks, reports, database structure, and define standards and procedures for traceability and auditability.
Topic 3	Testing Tasks: This section measures the skills of Data Managers and involves creating test plans, generating test data, executing validation and user acceptance testing, and documenting results to ensure systems and processes perform reliably and according to specifications.
Topic 4	Data Processing Tasks: This section measures skills of Clinical Systems Analysts and focuses on handling, transforming, integrating, reconciling, coding, querying, updating, and archiving study data while maintaining quality, consistency, and proper privileges over the data lifecycle.
Topic 5	Coordination and Project Management Tasks: This domain evaluates the skills of a Clinical Systems Analyst in coordinating data management workload, vendor selection, scheduling, cross-team communication, project timeline management, risk handling, metric tracking, and preparing for audits.

Q78. In a study conducted using paper CRFs, a discrepancy is discovered in a CRF to database QC audit. What is the reason why this discrepancy would be considered an audit finding?

Discrepancy not explained by the protocol

Discrepancy not explained by the CRF completion guidelines

Discrepancy not explained by the data handling conventions

Discrepancy not explained by the data quality control audit plan

Q79. For a study, body mass index is calculated from weight and height. Which information is needed to document the transformation?

Algorithm and algorithm version associated with the calculated value

Algorithm associated with the calculated value

User ID making the change and reason for change

Algorithm documented in the Data Management Plan

Q80. The primary reason for system validation is to:

Allow a system to be used by its intended users.

Fulfill the validation plan.

Meet regulatory requirements.

Prove the system being tested works as intended.

Q81. A Data Manager is asked to manage SOPs for a department. Given equal availability of the following systems, which of the following is the best choice for managing the organizational SOPs?

Document management system

Customized Excel spreadsheet

Learning management system

Existing paper filing system

Q82. A study numbers subjects sequentially within each site and does not reuse site numbers. Which information is required when joining data across tables?

Subject number and site number

Subject number

Study number and subject number

Site number

When subjects are numbered sequentially within each site, it means that the subject identification numbers (Subject IDs) restart from 001 at each site. For example, Site 101 may have Subject 001, and Site 102 may also have a Subject 001. In such cases, the subject number alone is not globally unique across the entire study. Therefore, when integrating or joining data across multiple database tables (for example, linking demographic, adverse event, and laboratory data), both the site number and the subject number are required to create a unique key that accurately identifies each record.
According to the Good Clinical Data Management Practices (GCDMP, Chapter on CRF Design and Data Collection), every data record in a clinical trial database must be uniquely and unambiguously identified. This is typically achieved through a composite key, combining identifiers such as site number, subject number, and sometimes study number. The GCDMP specifies that a robust data structure must prevent duplication or mislinking of records across domains or tables.
Furthermore, FDA and CDISC standards (SDTM model) also emphasize the importance of unique subject identifiers (USUBJID), which are derived from concatenating the study ID, site ID, and subject ID. This ensures traceability, integrity, and accuracy of subject-level data during database joins, data exports, and regulatory submissions.
Thus, in the described scenario, since subject numbering restarts at each site, both the site number and subject number are required to uniquely identify and correctly join subject data across different datasets or tables.
Reference (CCDM-Verified Sources):
SCDM Good Clinical Data Management Practices (GCDMP), Chapter: CRF Design and Data Collection, Section 4.1 – Unique Subject Identification CDISC SDTM Implementation Guide, Section 5.2 – Subject and Site Identification (Variable: USUBJID) FDA Guidance for Industry: Computerized Systems Used in Clinical Investigations, Section 6 – Data Integrity and Record Identification

Q83. A study collects blood pressure. Which is the best way to collect the data?

Coding a verbatim field with a MedDRA diagnosis

Two continuous variables

High/Low radio button

Check boxes for twenty-point increments

Q84. The serious adverse event (SAE) database should be reconciled against the clinical trial database prior to which occasion?

Case report form data entry

Expedited safety reporting

Database quality audit

Database closure or locking

Q85. Which of the following actions is particularly important in merging data from different trials?

Use of a common software platform

Enrollment of investigative sites with similar patient populations

Exclusion of studies that use a cross-over design

Use of a common adverse event dictionary

Q86. Which statement is true regarding User Acceptance Testing (UAT) in an EDC application?

System tools in EDC do not remove the need for UAT

Data should not be collected in a production environment until UAT is completed

Every rule should be tested with at least one “pass” and one “fail” scenario

The extent of UAT (i.e., the number of test cases and rules) cannot be risk-based

Q87. Which is the most important reason for why a data manager would review data before a monitor reviews it?

Data managers write the Data Management Plan that specifies the data cleaning workflow.

Data can be viewed and discrepancies highlighted prior to a monitor’s review.

Data managers have access to programming tools to identify discrepancies.

The GCDMP recommends that data managers review data prior to a monitor’s review.

Q88. Which data are needed to monitor site variability in eligibility screening?

Number of sites with low enrollment

Number of subjects screened and number of subjects enrolled

Number of subjects enrolled

Number of sites with high enrollment

Q89. Which protocol section best defines data needed for the primary study analysis?

Study schedule of events

Study endpoints section

Protocol synopsis

ICH essential documents

Q90. Data from two sites are combined. One site coded gender as 1 and 2 (for Male and Female, respectively) while the other stored the data as M and F. Which term best describes the mapping?

Two-to-two

One-to-many

Many-to-one

One-to-one

Q91. In an EDC study, user training and access must be monitored and addressed when all the following situations occur EXCEPT:

Site staff moves off of the study.

Site staff is new to the study.

A software upgrade is made that does not impact site staff or study team members.

Study team members are reassigned to a different role within the study.

Q92. During testing of an ePRO system, a test fails. Which information should be found in the validation documentation?

Training requirements

Expected and actual results

Reconciliation datapoints

Root cause analysis of the system errors

Q93. A Clinical Data Manager reads a protocol for a clinical trial to test the efficacy of an antiviral to counteract a new epidemic. The stated primary efficacy endpoint is 3-month survival. Which data element is needed for the primary efficacy endpoint?

Death date

Date of autopsy

Cause of death

Birth date

Q94. An asthma study is taking into account local air quality and receives that data from the national weather bureau. Which information is needed to link research subject data to the air-quality readings?

Location identifier

Location and time identifiers

Location, time and subject identifiers

Location, time, subject and site identifiers

Q95. Which metric reveals the timeliness of the site-work dimension of site performance?

Time from Last Patient Last Visit to database lock

Time from final protocol to first patient enrolled

Time from site contract execution to first patient enrolled

Median and range of time from query generation to resolution

Q96. A Data Manager is importing data from an external facility. Which is commonly checked first?

Incoming files have the expected number of records

Incoming files are conformant to the data transfer specifications

Data in incoming files are consistent with existing data in the study database

Data in the incoming files are internally consistent

Q97. An organization has completed a study and wants to submit the data to the FDA using CDISC SDTM. Which of the following must be done?

Map and transform the study data to SDTM

Re-enter the data into an SDTM compliant system

Provide a letter of intent to use SDTM to the FDA

SDTM cannot be used in this situation

Q98. Which is the MOST appropriate flow for EDC set-up and implementation?

CRF “wire-frames” created, CRFs reviewed, CRFs printed, CRFs distributed to sites

Protocol finalized, Database created, Edit Checks created, Database tested, Sites trained

Database created, Subjects enrolled, Database tested, Sites trained, Database released

Database created, Database tested, Sites trained, Protocol finalized, Database released

Q99. Which is the best way to identify sites with high subject attrition?

Proportion of patients for which two visit periods have passed without data by site

Number of late visits per site

Proportion of late visits by site

Number of patients for which two visit periods have passed without data

Q100. A statistician analyzes data from a randomized, double-blind, placebo-controlled study and finds that the placebo outperformed the investigational product. Which of the following is a plausible explanation for this?

The placebo was intended to contain medicinal properties.

Sites appropriately dispensed the investigational product to the subjects.

The treatment codes were incorrectly entered into the database.

The investigational product performed well in this study population.

Q101. The Scope of Work would answer which of the following information needs?

To determine the number of data transfers budgeted for a project

To look up the date of the next clinical monitoring visit for a specific site

To look up which visit PK samples are taken

To find the name and contact information of a specific clinical data associate

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[Feb 04, 2026] CCDM Free Exam Questions with Quality Guaranteed [Q78-Q101]

SCDM CCDM Exam Syllabus Topics:

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