Free SCDM CCDM Exam Dumps Questions & Answers

Which of the following is a best practice for creating eCRFs for a study?

• A.  Develop eCRFs with cross-functional team members
• B.  Develop eCRFs that closely follow paper CRF standards
• C.  Set up features that automatically enter data into fields when bypassed
• D.  Set up coded terms so they are available to the site user

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?

• A.  SNOMED terms used in the therapeutic area
• B.  Data elements used in clinical registries in the therapeutic area
• C.  A CDISC therapeutic-area implementation guide
• D.  Forms used by other sponsors in the same therapeutic area

An external organization has been hired to manage SAE follow-up for a large study. Which of the following would be used as guidance for exchange of the SAE data between the EDC system and the vendor's safety management system?

• A.  Submission Data Tabulation Model
• B.  Individual Case Safety Report
• C.  Biomedical Research Domain Model
• D.  Medical Document for Regulatory Activities

The Scope of Work would answer which of the following information needs?

• A.  To look up the date of the next clinical monitoring visit for a specific site
• B.  To determine the number of database migrations budgeted for a project
• C.  To find the name and contact information of a specific clinical data associate
• D.  To look up which visit PK samples are taken

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?

• A.  Single-blind
• B.  Double-blind
• C.  Open label
• D.  Cross-over