SCDM
CCDM
Q1:
A study is collecting ePRO assessments as well as activity-monitoring data from a wearable device. Which data should be collected from the ePRO and activity-monitoring devices to synchronize the device data with the visit data entered by the site?
○
A
Study subject identifier○
B
Study subject identifier and date/time○
C
Geo-spatial location○
D
Geo-spatial location and study subject identifier
SCDM
CCDM
Q2:
Which of the following scenarios requires a query to be sent to the central lab first when there is a discrepancy between the final lab data transfer and the CRF?
○
A
Both the central lab and the CRF have data present for a visit○
B
The CRF has data for a visit but the central lab has missing data for the visit○
C
The central lab has data for a visit but the CRF has missing data for the visit○
D
Both the central lab and the CRF data have missing data for a visit
SCDM
CCDM
Q3:
A Data Manager is importing data from an external facility. Which is commonly checked first?
○
A
Incoming files have the expected number of records○
B
Incoming files are conformant to the data transfer specifications○
C
Data in incoming files are consistent with existing data in the study database○
D
Data in the incoming files are internally consistent
SCDM
CCDM
Q4:
According to ICH E6, developing a Monitoring Plan is the responsibility of whom?
○
A
Sponsor○
B
CRO○
C
Data Manager○
D
Monitor
SCDM
CCDM
Q5:
Which data are needed to monitor site variability in eligibility screening?
○
A
Number of sites with low enrollment○
B
Number of subjects screened and number of subjects enrolled○
C
Number of subjects enrolled○
D
Number of sites with high enrollment