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CCDM Practice Questions

Certified Clinical Data Manager

Last Update 1 day ago
Total Questions : 150

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Our free Clinical Data Management practice questions crafted to reflect the domains and difficulty of the actual exam. The detailed rationales explain the 'why' behind each answer, reinforcing key concepts about CCDM. Use this test to pinpoint which areas you need to focus your study on.

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Question # 31

QA is conducting an audit on a study for ophthalmology which is ready for lock. Inconsistencies are found between the database and the source. Of the identified fields containing potential data errors, which fields are considered critical for this particular study?

Options:

A.  

Subject Identifier

B.  

Concomitant Medications

C.  

Weight

D.  

Medical History

Discussion 0
Question # 32

Which of the following is a best practice for creating eCRFs for a study?

Options:

A.  

Set up coded terms so they are available to the site user

B.  

Set up features that automatically enter data into fields when bypassed

C.  

Develop eCRFs with cross-functional team members

D.  

Develop eCRFs that closely follow paper CRF standards

Discussion 0
Question # 33

A CRF was approved by the Sponsor and development of a clinical database has been started according to the data management plan. What is the next responsibility of the Data Manager?

Options:

A.  

Prepare a communications plan

B.  

Prepare system requirements specification

C.  

Plan the timelines to ensure a clinical database is ready before the first screening

D.  

Prepare a data validation plan for the clinical database

Discussion 0
Question # 34

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

Options:

A.  

Coding a verbatim field with a MedDRA diagnosis

B.  

Two continuous variables

C.  

High/Low radio button

D.  

Check boxes for twenty-point increments

Discussion 0
Question # 35

A Clinical Data Manager is drafting data element definitions for a new study. One of the definitions provided is:

"Baby's crown to heel length measured lying on back, measured physical quantity, precision of 0.1."

Which of the following is missing from the definition?

Options:

A.  

Discrete values for a drop-down list

B.  

Enumeration

C.  

Data type of the data element

D.  

Unit or dimensionality of measure

Discussion 0
Question # 36

During an inspection to determine appropriate documentation for use of a computerized system, what SOP might the inspector expect to find?

Options:

A.  

Data management plan

B.  

Data backup plan

C.  

Statistical analysis plan

D.  

Edit specifications

Discussion 0
Question # 37

Which attribute is NOT a characteristic of a standardized data collection element?

Options:

A.  

An unambiguous definition for the data element

B.  

A strictly enforced requirement for the positioning of each data element on a case report form

C.  

A standard set of values used to respond to a data collection question

D.  

A unique set of data storage metadata, including a variable name and data type

Discussion 0
Question # 38

ePRO data are collected for a study using study devices given to subjects. Which is the most appropriate quality control method for the data?

Options:

A.  

Programmed edit checks to detect out of range values after submission to the database

B.  

Manual review of data by the site study coordinator at the next visit

C.  

Data visualizations to look for site-to-site variation

D.  

Programmed edit checks to detect out of range values upon data entry

Discussion 0
Question # 39

A Data Manager is designing a CRF for a study for which the efficacy data are not covered by the current SDTM domains. Which search should the Data Manager do?

Options:

A.  

Use controlled terminology covering the needed concepts

B.  

Work with the study team to define new data elements

C.  

Search for relevant data element standards

D.  

Advise the study team not to collect the data

Discussion 0
Question # 40

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

Options:

A.  

Time from Last Patient Last Visit to database lock

B.  

Time from final protocol to first patient enrolled

C.  

Time from site contract execution to first patient enrolled

D.  

Median and range of time from query generation to resolution

Discussion 0
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