Free SCDM CCDM Exam Dumps Questions & Answers

A study team member wants to let sites enroll patients before the system is ready. Which are important considerations?

• A.  Starting the study prior to the EDC system being ready will delay processing of milestone-based site payments
• B.  There is no way to identify, report and track adverse events and serious adverse events without the EDC system in place
• C.  If the study were audited, enrolling subjects prior to having the EDC system ready would become an audit finding
• D.  Without the ability to capture the data electronically, the data cannot be checked or used to monitor and manage the study

Which of the following actions is particularly important in merging data from different trials?

• A.  Exclusion of studies that use a cross-over design
• B.  Enrollment of investigative sites with similar patient populations
• C.  Use of a common software platform
• D.  Use of a common adverse event dictionary

Which of the following is the best reason for a statistician to review the case report form prior to using it in a study?

• A.  To ensure the header fields will provide a unique key for each subject
• B.  To ensure the layout will make a logical, useful programming guide
• C.  To ensure the variable names conform to statistical programming standards
• D.  To ensure the data from the CRF can be analyzed for safety and efficacy

What are the key deliverables for User Acceptance Testing?

• A.  eCRF Completion Guidelines
• B.  Project Plan
• C.  Test Plan/Script/Results
• D.  Training

Which competency is necessary for EDC system use in a study using the medical record as the source?

• A.  Screening study subjects
• B.  Resolving discrepant data
• C.  Training on how to log into Medical Records system
• D.  Using ePRO devices