CCDM 試験問題を無料オンラインアクセス

The serious adverse event (SAE) database should be reconciled against the clinical trial database prior to which occasion?

• A.Case report form data entry
• B.Database closure or locking
• C.Database quality audit
• D.Expedited safety reporting

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?

• A.Statistician
• B.Investigator
• C.Data Manager
• D.Quality Auditor

What is the primary benefit of using a standard dictionary for medications?

• A.To facilitate the reporting and analysis of possible drug interactions
• B.To standardize recording of medications taken by patients across sites
• C.To identify differences in medication components based on country of source
• D.To improve safety monitoring of patients in a clinical trial setting

Which is the MOST appropriate flow for EDC set-up and implementation?

• A.Database created, Subjects enrolled, Database tested, Sites trained, Database released
• B.Protocol finalized, Database created, Edit Checks created, Database tested, Sites trained
• C.CRF "wire-frames" created, CRFs reviewed, CRFs printed, CRFs distributed to sites
• D.Database created, Database tested, Sites trained, Protocol finalized, Database released

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.Comparison to the measurement from the previous visit
• B.Independent assessment by a second physical therapist during the visit
• C.Programmed edit checks to detect out-of-range values upon data entry
• D.Reviewing data listings for illogical changes in range of motion between visits