Welcome to the Quiz on Clinical Data Management

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Metrics reporting is now a key function of the data management ________
Demographics, medical history and entry criteria fall under ______________ category.
______ document is a road map to handle the data under foreseeable circumstances and describes the CDM activities to be followed in the trial.
____ systems are designed specifically to support clinical data management groups in carrying out tasks over multiple and simultaneous studies.
In Oracle Clinical, a Compound can be Assigned to a Program in the Plan Subsystem only if a record of this compound has been created within the Design Subsystem under -------------------
The annual safety report should be submitted within __________of the end of the reporting year.
A DCF should only be closed or deleted, if all the discrepancies on the DCF have been actioned properly and their status on the DCF is:
Good Clinical Data Management Practices is published by
_______is carried out to ensure that the system rejects erroneous input in the proper ways.
Validation requires that the programs be tested not just to be sure that they run correctly under normal circumstances, but that they also run as expected when data exceptions or errors are processed. The statement is
The Unique Namespaces within Oracle Clinical that are created within the Global Library are called:
Assertion: Collecting too much data on a CRF can be detrimental.
Reason: As the volume of required data increases, the more the quality of data recorded on case report forms can decrease.
Identify the correct order of sequence for clinical data management activities:
i. The identification of the data items to be collected for the trial.
ii. The design of the data collection forms.
iii. The design and setup of the trial database.
A study can be locked only after
Loading programs for lab data can be greatly simplified when a___________ is used.
Close tracking of data entry means that performance measures can be
A Univariate Discrepancy is created because Date of Birth was blank on the CRF and therefore not entered into the database. A DCF was then sent to the Investigator and he has replied back on the DCF providing the Date of Birth as 30-MAR-1982. The Discrepancy is then resolved by updating the database. The System Status, Review Status, and Resolution Status will respectively be as follows:
If a study has 7 visits, then the termination type for Visit 1 that is defined when creating Events will be:
Assertion: Coding is necessary.
Reason: It required little space for storage on the database and made searching easier.
The last step in the CRF development process, prior to sending CRF for programming is