Certified Clinical Data Manager
Last Update Oct 15, 2025
Total Questions : 150
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Which protocol section best defines data needed for the primary study analysis?
If database auditing is used for data quality control during a study, which is the optimal timing of the audits?
Which of the following is the best reason for a statistician to review the case report form prior to using it in a study?
During testing of an ePRO system, a test fails. Which information should be found in the validation documentation?
Which type of edit check would be implemented to check the correctness of data present in a text box?
If a data manager generated no additional manual queries on data in an EDC system and the data were deemed clean, why could the data appear to be not clean during the next review?
Data characterizing the safety profile of a drug are collected to provide information for which of the following?
Which method would best identify inaccuracies in safety data tables for an NDA?
All of the following are preparation processes the data manager needs to take prior to database closure EXCEPT:
Which of the following scenarios requires a query to be sent to the central lab first when there is a discrepancy between the final lab data transfer and the CRF?
Which is the best reason why front-end checks are usually kept minimal, when compared to back-end checks, in a paper-based clinical study?
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?
Before the EDC system used for the trial is upgraded, what should be the data manager's first task?
In an EDC study, an example of an edit check that would be inefficient to run at data entry is a check:
What is the purpose of providing the central laboratory vendor with a complete listing of subjects' demographic data?
A study team member suggests that data for a small, 50-patient, 2-year study can be entered and cleaned in two weeks before lock. Which are important other considerations?
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?
Which of the following laboratory findings is a valid adverse event reported term that facilitates auto coding?
For a study, body mass index is calculated from weight and height. Which information is needed to document the transformation?
Which of the following roles commonly requires data entry and update privileges in an EDC application used in a clinical study?
What is the main reason 21 CFR Part 11 requires that EDC systems maintain an audit trail?
Which metric reveals the timeliness of the site-work dimension of site performance?
To ensure data quality and efficient integration of data, which of the following best describes the main topic that should be covered in initial discussions with a vendor providing the external data?
In a study conducted using paper CRFs, a discrepancy is discovered in a CRF to database QC audit. What is the reason why this discrepancy would be considered an audit finding?
ACME Intervention Co. is testing a new carotid artery stent in patients with coronary artery disease, in hopes of proving superiority over the current standard of care. After a subject signs consent, the surgeon enrolls the patient and retrieves information on which stent to use, but the surgeon does not share this information with the subject. Yesterday, the surgeon was instructed to use the control stent. Today, the surgeon has completed two surgeries: the first one the surgeon was instructed to use the control stent; the second one the surgeon was instructed to use the test stent. In what type of trial is the surgeon participating?
At a cross-functional study team meeting, a statistician suggests collecting blood gases electronically through the existing continuous hemodynamic monitoring system at sites rather than having a person record the values every five minutes during the study procedure. Assuming that sending, receiving, and integrating these data are possible, what is the best response?
An organization has completed a study and wants to submit the data to the FDA using CDISC SDTM. Which of the following must be done?
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 site study coordinator attempts to make an update in a study database in an EDC system after lock. What occurs?
During a database audit, it was determined that there were more errors than expected. Who is responsible for assessing the overall impact on the analysis of the data?
Which of the following statements would be BEST included in a data management plan describing the process for making self-evident corrections in a clinical database?
Who has primary responsibility for ensuring accurate completion of the CRF?
An organization is using an international data exchange standard and a new version is released. Which of the following should be assessed first?
What is the primary benefit of using a standard dictionary for medications?
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?
In an EDC study, user training and access must be monitored and addressed when all the following situations occurEXCEPT:
An international study collects lab values. Sites use different units in the source documents. Which of the following data collection strategies will have fewer transcription errors?
Which protocol section most concisely conveys timing of data collection throughout a study?
A sponsor may transfer responsibility for any or all of their obligations to a contract research organization. Which of the following statements is true?
A study is using blood pressure as an efficacy measure. Which is the best way to collect the data?
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?
TESTED 15 Oct 2025
