CCDM 무료 덤프문제 온라인 액세스

A Data Manager is establishing a timeline for database lock for a 100-person study where the data have been maintained almost all clean throughout the study. All data from external labs have been received and reconciled. Which is the best estimate of the amount of time needed to lock the database after Last Patient Last Visit?

• A.A few days
• B.A few hours
• C.A few weeks
• D.A few months

Which document contains the details of when, to whom, and in what manner the vendor data will be sent?

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

Data from two sites are combined. One site coded gender as 1 and 2 (for Male and Female, respectively) while the other stored the data as M and F. Which term best describes the mapping?

• A.One-to-many
• B.Many-to-one
• C.One-to-one
• D.Two-to-two

A Clinical Data Manager reads a protocol for a clinical trial to test the efficacy and safety of a new blood thinner for prevention of secondary cardiac events. The stated endpoint is all-cause mortality at 1 year. Which data element would be required for the efficacy endpoint?

• A.Coagulation time
• B.Date of death
• C.Drug level
• D.Cause of death

In a cross-functional team meeting, a monitor mentions performing source data verification (SDV) on daily diary data entered by patients on mobile devices. Which of the following is the best response?

• A.The diary data should not be source data verified
• B.Diary data to be source data verified should be randomly selected
• C.All diary data should be source data verified
• D.Diary data to be source data verified should be selected using a risk-based approach