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Guide for CCDM: SCDM Certified Clinical Data Manager

Quiz CCDM: SCDM Certified Clinical Data Manager

Updated on 2026/06/07

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Guide for CCDM: SCDM Certified Clinical Data Manager

Updated on 2026/06/07

Randomized | 10 Questions per Test | 20 Minutes | 70% to pass

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Question: / 10

5.0

Quiz

Question 1/101/10

According to the FDA Guidance for Industry, Providing Regulatory Submissions in Electronic Format
(April 2006) and Good Clinical Data Management Practices (GCDMP, May 2007), which of the
following is the most acceptable for a derived field?

Select the answer:Select the answer

1 correct answer

Providing CRF annotation "not entered in the database" next to the average score

Providing the algorithm for calculating the average score on the CRF

Providing the algorithm for calculating the average score in the dataset definition file

Providing CRF annotation AVE next to the average score

In clinical data management, a derived field refers to any variable that is not directly collected from
the Case Report Form (CRF) but is instead calculated or inferred from one or more collected variables
(for example, calculating an average blood pressure from multiple readings). Proper documentation
of derived fields is essential for ensuring data traceability, transparency, and compliance with both
FDA and SCDM guidelines.
According to the Good Clinical Data Management Practices (GCDMP, May 2007), all derivations and
transformations applied to clinical data must be clearly defined and documented in metadata such as
the dataset definition file (also referred to as data specifications, variable definition tables, or
Define.xml files). The derivation algorithm should be explicitly stated in this documentation to allow
independent verification, regulatory review, and reproducibility of results.
The FDA Guidance for Industry (April 2006) on electronic submissions further emphasizes that
derived fields must be supported by comprehensive metadata that defines the computational
method used. This documentation enables the FDA or any regulatory body to audit and reproduce
analytical results without ambiguity. Annotating or describing derivations directly on the CRF (as in
options A, B, or D) is not sufficient, as CRFs represent data collection instruments—not analytical
documentation.
Therefore, the correct and regulatory-compliant practice is to provide the derivation algorithm for a
calculated field within the dataset definition file, aligning with both FDA and GCDMP expectations for
data integrity and auditability.
Reference (CCDM-Verified Sources):
Society for Clinical Data Management (SCDM), Good Clinical Data Management Practices (GCDMP),
Chapter: Data Handling and Processing – Derived and Calculated Data Fields, Section 5.3.3
FDA Guidance for Industry: Providing Regulatory Submissions in Electronic Format, April 2006,
Section 3.2 on Dataset Documentation Requirements
CDISC Define.xml Implementation Guide – Metadata and Algorithm Documentation for Derived
Variables

Right Answer: C

Quiz

Question 2/102/10

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

Select the answer:Select the answer

1 correct answer

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

Right Answer: A

Quiz

Question 3/103/10

Which of the following factors can be tested through a second test transfer?

Select the answer:Select the answer

1 correct answer

Change management

File format

Transfer method

Transfer frequency

Quiz

Question 4/104/10

Which of the following statements would be BEST included in a data management plan describing
the process for making self-evident corrections in a clinical database?

Select the answer:Select the answer

1 correct answer

A senior level data manager may make audited changes to the database without further documentation.

Self-evident corrections made in the database will be reviewed and approved by a team leader or manager.

No changes will be made in the database without a query response signed by the investigator.

Self-evident changes may be made per the listed conventions and documented to the investigative site.

Quiz

Question 5/105/10

Which document contains the details of when, to whom, and in what manner the vendor data will be
sent?

Select the answer:Select the answer

1 correct answer

Project Plan

Communication Plan

Data Transfer Agreement

Data Management Plan

Quiz

Question 6/106/10

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

Select the answer:Select the answer

1 correct answer

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

Quiz

Question 7/107/10

What is the main reason 21 CFR Part 11 requires that EDC systems maintain an audit trail?

Select the answer:Select the answer

1 correct answer

To preserve data integrity

To preserve the ability for modifications

To preserve source document verifications

To preserve data availability

Quiz

Question 8/108/10

Electronic submission standards require that an individual subject's complete CRF should be provided
as what type of file:

Select the answer:Select the answer

1 correct answer

Portable Document Format (.pdf)

Rich Text Format (.rtf)

Microsoft Word (.docx)

Statistical Analysis System (.sas)

Quiz

Question 9/109/10

Which document describes what study subjects expect with respect to data disclosure during and
after a study?

Select the answer:Select the answer

1 correct answer

Study data sharing plan

ICH essential documents

Informed consent form

Study protocol

Quiz

Question 10/1010/10

Every database lock should follow documented approval of which stakeholders?

Select the answer:Select the answer

1 correct answer

Clinical/Scientific Representative, Data Manager, Biostatistician

Clinical/Scientific Representative, Biostatistician, Programmer

Clinical/Scientific Representative, Data Manager

Clinical/Scientific Representative, Biostatistician

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Quiz name:CCDM: SCDM Certified Clinical Data Manager
Total number of questions:150
Number of questions for the test:50
Pass score:80%

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