Free SCDM CCDM Practice Test & Real Exam Questions

Which protocol section best defines data needed for the primary study analysis?

Which information should be communicated by the Data Manager at regular intervals throughout a study?

During an inspection to determine appropriate documentation for use of a computerized system, what SOP might the inspector expect to find?

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

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?

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

Which of the following roles commonly requires data entry and update privileges in an EDC application used in a clinical study?

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?

Before the EDC system used for the trial is upgraded, what should be the data manager's first task?

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?

Which document describes what study subjects expect with respect to data disclosure during and after a study?