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

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

A site study coordinator attempts to make an update in a study database in an EDC system after lock. What occurs?

• A. The old value is replaced in all locations by the new value
• B. The change is approved by the Data Manager before it is applied
• C. The site study coordinator is not able to make the change
• D. The change is logged as occurring after lock

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

Which protocol section most concisely conveys timing of data collection throughout a study?

• A. Protocol synopsis
• B. Study endpoints section
• C. Study schedule of events
• D. ICH essential documents

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