CCDM by SCDM Actual Free Exam Questions And Answers

Question 1

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. One-to-many

B. One-to-one

C. Many-to-one

D. Two-to-two

Discussion 0

Correct Answer: B Vote an answer

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Question 2

What does 21 CFR Part 11 dictate in regards to a minimum expectation of EDC training prior to access?

A. Training must include an exam

B. Training must be in the user's native language

C. Training must be face to face

D. Training must be performed

Discussion 0

Correct Answer: D Vote an answer

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Question 3

All range and logic checks have been resolved in a study. An auditor found discrepancies between the database and the source. Which reason is most likely?

A. The auditor made an error

B. Data were changed after the checks were run

C. Data were not abstracted correctly from the source

D. The discrepant data values were logical and in range

Discussion 0

Correct Answer: C Vote an answer

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Question 4

A study uses commercially available activity monitors and collects data for each patient weekly by selecting and downloading the data from the manufacturer's website. There are 100 patients in the study and it takes the Data Manager 20 minutes per file to download, import, and process the dat a. Assuming that the distribution of work is uniform over the six-month trial, how many Data Managers are needed for the activity data alone?

A. Ten percent of a Data Manager per month

B. Two Data Managers per month

C. One Data Manager per month

D. Fifty percent of a Data Manager per month

Discussion 0

Correct Answer: C Vote an answer

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Question 5

A protocol amendment adds three data elements to the vital signs screen and two additional data-collection time points. Which is best practice for handling changes to the form completion guidelines?

A. Rely on the revised CRF to enforce the changes without updating guidelines or notifying sites

B. Update the guidelines and post the new version on the trial portal

C. Update the guidelines and notify sites of changes prior to implementing the change

D. Notify sites of the change without a guideline update

Discussion 0

Correct Answer: C Vote an answer

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Question 6

On a dose escalation study, the Data Manager notices one site has a much higher number of queries than other sites and most are older than 30 days. The Data Safety Monitoring Board will meet in three weeks. What should the Data Manager providing CRO oversight do?

A. Call the site directly and ask the study coordinator about the concerns

B. Consult the CRO's Lead Data Manager and the CRO's Project Leader

C. Notify the CRO's Clinical Leader about the concerns

D. Ignore it for now and check back next week

Discussion 0

Correct Answer: B Vote an answer

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Question 7

An astute monitor discovers that a site is using nebulized albuterol rather than the inhaler provided in the study screening kit for the albuterol challenge. Which is the best response from the Data Manager?

A. No response is needed, the problem does not impact data

B. Query the site to enter a Protocol Violation

C. Update the CRF Completion Guidelines and notify all sites of the update

D. Contact the Ethics Committee

Discussion 0

Correct Answer: B Vote an answer

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Question 8

A study is collecting ePRO assessments as well as activity-monitoring data from a wearable device. Which data should be collected from the ePRO and activity-monitoring devices to synchronize the device data with the visit data entered by the site?

A. Study subject identifier and date/time

B. Geo-spatial location

C. Geo-spatial location and study subject identifier

D. Study subject identifier

Discussion 0

Correct Answer: A Vote an answer

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Question 9

What should be done if the site continues to provide inconsistent data after several re-queries?

A. Escalate the issue to the appropriate site contact personnel

B. Gently lead the site to the correct response

C. Do nothing, the data will remain inconsistent

D. Continue to re-query until the site changes the data

Discussion 0

Correct Answer: A Vote an answer

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Question 10

What is the purpose of providing the central laboratory vendor with a complete listing of subjects' demographic data?

A. To provide for an independent reconciliation of the patient and remote databases after database lock

B. To assure that all subjects have lab data for valid visits

C. To provide for an independent reconciliation of the patient and remote databases during study conduct

D. To assure that lab data for screening failure subjects have not been included in the lab data transmission

Discussion 0

Correct Answer: C Vote an answer

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Question 11

In a study, data are key entered by one person after which a second person enters the data without knowledge of or seeing the values entered by the first. The second person is notified during entry if an entered value differs from first entry and the second person's decision is retained as the correct value. Which type of entry is being used?

A. Single entry

B. Blind verification

C. Manual review

D. Third-party compare

Discussion 0

Correct Answer: B Vote an answer

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Question 12

Which is a minimum prerequisite that should be in place before choosing an EDC system?

A. Completed installation qualification

B. Updated governance documentation

C. Draft validation plan

D. Knowledge of functional requirements

Discussion 0

Correct Answer: D Vote an answer

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Question 13

What action should be taken regarding the clinical database when MedDRA releases a new version of its dictionary?

A. Identify an alternative dictionary.

B. Evaluate the extent and impact of the changes.

C. Continue using the existing version to code.

D. Upgrade the version immediately and recode.

Discussion 0

Correct Answer: B Vote an answer

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Question 14

A protocol is updated mid-study to add an additional procedure about which data needs to be collected. Which of these statements applies?

A. The DMP should be updated to reflect the changes to the protocol, but this update does not need to be communicated

B. The DMP does not need to be updated as it represents the data at the beginning of the trial only

C. The DMP should be updated to reflect the changes to the protocol and stakeholders notified

D. The DMP does not need to be updated until the end of the trial and all updates are included in the DMP to indicate what happened in the trial

Discussion 0

Correct Answer: C Vote an answer

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Question 15

In a physical therapy study, range of motion is assessed by a physical therapist at each site using a study-provided goniometer. Which is the most appropriate quality control method for the range of motion measurement?

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

B. Reviewing data listings for illogical changes in range of motion between visits

C. Comparison to the measurement from the previous visit

D. Independent assessment by a second physical therapist during the visit

Discussion 0

Correct Answer: D Vote an answer

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SCDM Certified Clinical Data Manager - CCDM Exam Practice Test

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