Free SCDM CCDM Exam Questions

Become SCDM Certified with updated CCDM exam questions and correct answers

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Total 150 Questions | Updated On: Oct 29, 2025

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Question 1

In reviewing the adverse events for a subject, a data manager notices one recorded as "worsening of migraine." After reviewing the rest of the adverse events and finding no other migraine recordings, what is the data manager's next step?

A : Look for any adverse event instance of headache and assume the events are similar.

B : Query the site for the first adverse event occurrence of migraine.

C : Check the medical history for recording of a history of migraines.

D : Query the site for more information on the adverse event, "worsening of migraine."

Answer: D

Question 2

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

A : Training requirements

B : Expected and actual results

C : Reconciliation datapoints

D : Root cause analysis of the system errors

Answer: B

Question 3

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

A : Data elements used in clinical registries in the therapeutic area

B : SNOMED terms used in the therapeutic area

C : Forms used by other sponsors in the same therapeutic area

D : A CDISC therapeutic-area implementation guide

Answer: D

Question 4

An external organization has been hired to manage SAE follow-up for a large study. Which of the following would be used as guidance for exchange of the SAE data between the EDC system and the vendor's safety management system?

A : Medical Document for Regulatory Activities

B : Biomedical Research Domain Model

C : Individual Case Safety Report

D : Submission Data Tabulation Model

Answer: C

Question 5

Which of the following SOPs are required for management of an EDC system?

A : Management of vendors

B : Measurement of data quality

C : Maintenance of coding dictionaries

D : Change control

Answer: D

Page: 1 / 30

Total 150 Questions | Updated On: Oct 29, 2025

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