SCDM CCDM Exam Dumps

QUESTION 150 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. Notify the CRO's Clinical Leader about the concerns 
B. Call the site directly and ask the study coordinator about the concerns 
C. Consult the CRO's Lead Data Manager and the CRO's Project Leader 
D. Ignore it for now and check back next week

Answer: C

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

What significant difference is there in the DM role when utilizing an EDC application? 

A. Data updates are implemented by the sites 
B. Database validation is not required 
C. Metrics generation is required 
D. Tracking of eCRFs is a monitor's responsibility

Answer: A

Which protocol section most concisely conveys timing of data collection throughout a study? 

A. Study endpoints section 
B. Study schedule of events 
C. Protocol synopsis 
D. ICH essential documents

Answer: B

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. Number of forms entered in the last week 
B. Expected versus actual forms entered 
C. List of outstanding forms 
D. Total number of forms entered to date 

Answer: C

For clinical investigational sites on an EDC trial, which of the following archival options allows traceability of changes made to data? 

A. Storing the computer used at the clinical investigational site 
B. Paper copies of the source documents 
C. PDF images of the final eCRF screens for each patient 
D. ASCII files of the site's data and related audit trails 

Answer: D

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? 

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

Answer: C

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

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 

Answer: D

Which action has the most impact on the performance of a relational database system? 

A. Entering data into the database from CRFs 
B. Loading a large lab data file into the database 
C. Executing a properly designed database query 
D. Making updates to data previously entered into the database

Answer: B

A Data Manager is asked to manage SOPs for a department. Given equal availability of the following systems, which of the following is the best choice for managing the organizational SOPs? 

A. Document management system 
B. Customized Excel spreadsheet 
C. Learning management system
 D. Existing paper filing system

Answer: A

For ease of data processing, the study team would like the database codes for a copyrighted rating scale preprinted on the CRF. What is the most critical task that the CRF designer must do to ensure the data collected on the CRF for the scale are reliable and will support the results of the final analysis? 

A. Consult the independent source and determine database codes will not influence subject responses. 
B. Consult the study statistician regarding the change and determine that database codes will not influence the analysis. 
C. Consult the independent source of the rating scale for approval and document that continued validity of the tool is not compromised. 
D. Complete the requested changes to the instrument and ensure the correct database codes are associated with the appropriate responses.

Answer: C