CCDM 無料問題集「SCDM Certified Clinical Data Manager」

（A）Lab values from a blood draw with a very high sodium and very low other values

（B）Lab values from a blood draw with a very low sodium and very high other values

（C）Abnormally low urine glucose values in a dataset

（D）Abnormally high sodium values in a dataset

（A）Data review can be performed at a later time due to the paper-based studies being smaller in size

（B）Data entry staff should be able to enter a value into the database just as it appears in the paper CRF

（C）There are approvals required to raise a Data Clarification Form which could take time

（D）There is no need to alert the site personnel immediately about a data issue, as the study has happened already

（A）A description of each of the obligations being assumed by the contract research organization is required.

（B）Any written description is not transferred to the contract research organization.

（C）A description of each of the obligations being transferred to the contract research organization is not required.

（D）A general statement that all obligations have been transferred is acceptable.

（A）Spontaneous adverse event

（B）Severe adverse event

（C）Serious adverse event

（D）Adverse event

（A）The study coordinator can change the data due to re-review of the source.

（B）The data manager may have accidentally changed the data.

（C）The CRA can change the data during a quality review of source to database.

（D）The medical monitor can override safety information entered in the system.

（A）Sites appropriately dispensed the investigational product to the subjects.

（B）The treatment codes were incorrectly entered into the database.

（C）The placebo was intended to contain medicinal properties.

（D）The investigational product performed well in this study population.

（A）Description of statistical analysis methods

（B）Description of how data were processed

（C）Rationale for the study design

（D）Clinical narratives of adverse events

（A）Ignore it for now and check back next week

（B）Consult the CRO's Lead Data Manager and the CRO's Project Leader

（C）Call the site directly and ask the study coordinator about the concerns

（D）Notify the CRO's Clinical Leader about the concerns

（A）Investigator

（B）Clinical Research Associate

（C）Site Coordinator

（D）Clinical Data Manager

（A）Loading a large lab data file into the database

（B）Executing a properly designed database query

（C）Making updates to data previously entered into the database

（D）Entering data into the database from CRFs

（A）Making changes only on the copy of the received data

（B）Maintaining a copy of the data as received

（C）Making changes only after data have been imported

（D）Making changes only for exceptions

（A）Protocol synopsis

（B）ICH essential documents

（C）Study endpoints section

（D）Study schedule of events

（A）Remove the training items from the training matrix

（B）Send the two developers to the required training

（C）Reprimand the person responsible for maintaining training documentation

（D）Identify the root cause and improve the process to prevent it

（A）Programmed edit checks to detect out-of-range values upon data entry

（B）Independent assessment by a second physical therapist during the visit

（C）Reviewing data listings for illogical changes in range of motion between visits

（D）Comparison to the measurement from the previous visit