Certified Clinical Data Manager (CCDM) Free Practice Test

Question 1

The Medical Dictionary for Regulatory Activities (MedDRA) structure is in which of the following hierarchical orders, from most specific to least specific?

A. LLT, PT, HLGT, HLT, SOC

B. LLT, HLGT, PT, HLT, SOC

C. LLT, HLGT, HLT, PT, SOC

D. LLT, PT, HLT, HLGT, SOC

Correct Answer: D

Explanation: Only visible for TestSimulate members. You can sign-up / login (it's free).

Question 2

A data manager takes the INTERSECTION data in two tables wanting only the 50 records common to both tables. What operation did the data manager perform?

A. Full outer join

B. Inner join

C. Left outer join

D. Right outer join

Correct Answer: B

Explanation: Only visible for TestSimulate members. You can sign-up / login (it's free).

Question 3

A Data Manager is designing a report to facilitate discussions with sites regarding late dat a. Which is the most important information to display on the report to encourage sites to provide data?

A. Expected versus actual forms entered

B. List of outstanding forms

C. Total number of forms entered to date

D. Number of forms entered in the last week

Correct Answer: B

Explanation: Only visible for TestSimulate members. You can sign-up / login (it's free).

Question 4

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?

A. Two-to-two

B. Many-to-one

C. One-to-one

D. One-to-many

Correct Answer: C

Explanation: Only visible for TestSimulate members. You can sign-up / login (it's free).

Question 5

A study is collecting pain levels three times a day. Which is the best way to collect the data?

A. Using ePRO with reminders for data collection at each time point

B. Study subjects calling into an IVRS three times a day to enter pain levels

C. Using paper pain diary cards completed by study subjects

D. Sites calling patients daily and administering a pain questionnaire

Correct Answer: A

Explanation: Only visible for TestSimulate members. You can sign-up / login (it's free).

Question 6

Which information should an auditee expect prior to an audit?

A. Corrective action requests

B. Standard operating procedures

C. Audit plan or agenda

D. Auditor's credentials and certification number

Correct Answer: C

Explanation: Only visible for TestSimulate members. You can sign-up / login (it's free).

Question 7

The result set from the query below would be which of the following?
SELECT * FROM patient WHERE medical_record_number > 9000

A. Narrower than the patient table

B. Longer than the patient table

C. Shorter or of equal length than the patient table

D. Wider than the patient table

Correct Answer: C

Explanation: Only visible for TestSimulate members. You can sign-up / login (it's free).

Question 8

Which information is most useful in working with sites to catch up a backlog of unresolved queries at sites?

A. Table of outstanding queries counts by site

B. List of late queries by site and summary table

C. Graph and summary table of clean cases by site

D. Graph of expected versus actual enrollment

Correct Answer: B

Explanation: Only visible for TestSimulate members. You can sign-up / login (it's free).

Question 9

Which of the following processes is the most likely to remain in a study that utilizes electronic data capture?

A. Resolving queries

B. Retrieving case report forms

C. Updating the in-house database

D. Tracking case report forms

Correct Answer: A

Explanation: Only visible for TestSimulate members. You can sign-up / login (it's free).

Question 10

A Clinical Data Manager reads a protocol for a clinical trial to test the efficacy and safety of a new blood thinner for prevention of secondary cardiac events. The stated endpoint is all-cause mortality at 1 year. Which data element would be required for the efficacy endpoint?

A. Drug level

B. Date of death

C. Cause of death

D. Coagulation time

Correct Answer: B

Explanation: Only visible for TestSimulate members. You can sign-up / login (it's free).

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SCDM Certified Clinical Data Manager (CCDM) Free Practice Test