SCDM Certified Clinical Data Manager - CCDM FREE EXAM DUMPS QUESTIONS & ANSWERS

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

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

A. Check the medical history for recording of a history of migraines. B. Look for any adverse event instance of headache and assume the events are similar. C. Query the site for more information on the adverse event, "worsening of migraine." D. Query the site for the first adverse event occurrence of migraine.

A. Count by edit check of the number of times the check fired B. Count by site of the number of times any edit check fired C. Average number of edit check identified discrepancies per form D. Average number of times each edit check has fired

A. Implementing controlled terminology for adverse events B. Maintaining a library of form or screen modules C. Adopting an ODM compliant database system D. Improving the form or screen design process

A. Third party compare B. Double entry C. Blind verification D. Single entry

A. System tools in EDC do not remove the need for UAT B. Data should not be collected in a production environment until UAT is completed C. Every rule should be tested with at least one "pass" and one "fail" scenario D. The extent of UAT (i.e., the number of test cases and rules) cannot be risk-based

A. Project Plan B. Data Management Plan C. Communication Plan D. Data Transfer Agreement

A. Making changes only for exceptions B. Making changes only after data have been imported C. Making changes only on the copy of the received data D. Maintaining a copy of the data as received