When reviewing local lab data from a paper study, a Data Manager notices there are lab values not entered. What should the Data Manager request data-entry personnel do?
Which metric will identify edit checks that may not be working properly?
If database auditing is used for data quality control during a study, which is the optimal timing of the audits?
A study is using blood pressure as an efficacy measure. Which is the best way to collect the data?
During an inspection to determine appropriate documentation for use of a computerized system, what SOP might the inspector expect to find?
A Clinical Data Manager is drafting data element definitions for a new study. One of the definitions provided is:
"Baby's crown to heel length measured lying on back, measured physical quantity, precision of 0.1."
Which of the following is missing from the definition?
What action should a data manager take if an investigator retires in the middle of an EDC trial and the replacement does not agree to use EDC for the remainder of the trial?
Which database table structure is most appropriate for vital signs data collected at every-other visit for each patient in a study?
Which information should be communicated by the Data Manager at regular intervals throughout a study?
Before the EDC system used for the trial is upgraded, what should be the data manager's first task?