Clinical Data Management Assessment by ClinSkill | Oct 26, 2018 | 2 comments Welcome to the Quiz on Clinical Data Management Name Email address 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.ii, i, iiiii, i, iiii, ii, iiiiii, ii, i______ document is a road map to handle the data under foreseeable circumstances and describes the CDM activities to be followed in the trial.Statistical Analysis Plan (SAP)Data Management Plan (DMP)Good Clinical Practices (GCP)Data Validation Plan (DVP)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:INV REVIEWRECEIVEDEither of theseRELEASED_______is carried out to ensure that the system rejects erroneous input in the proper ways.Test reportStress testingTest procedure scriptTest planClose tracking of data entry means that performance measures can beTrackedManagedBoth of theseNone of theseThe Unique Namespaces within Oracle Clinical that are created within the Global Library are called:TablesViewsDomainsCRF objectsLoading programs for lab data can be greatly simplified when a___________ is used.Short fat formatTall-skinny formatBoth of theseNone of theseMetrics reporting is now a key function of the data management ________Project managerTeam LeaderBoth of theseNone of theseThe last step in the CRF development process, prior to sending CRF for programming isCRF version controlOfficial ‘sign off’Pre testingData confidentialityThe annual safety report should be submitted within __________of the end of the reporting year.30 days90 days60 days45 daysIf a study has 7 visits, then the termination type for Visit 1 that is defined when creating Events will be:Normal TerminationEarly TerminationNone of theseLeft BlankAssertion: 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.Both Assertion and Reason are correct but Reason doesn't explain AssertionBoth Assertion and Reason are correct and Reason explains AssertionOnly Assertion is correctBoth Assertion and Reason are wrongOnly Reason is correctDemographics, medical history and entry criteria fall under ______________ category.One record per patientNone of the aboveOne record per patient per visitMultiple records per patient per visitAll of the aboveA study can be locked only afterFirst patient’s first visitLast patient’s first visitLast patient’s last visitFirst patient’s last visitValidation 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 isTrueFalseGood Clinical Data Management Practices is published byClinical Research SocietyClinical Data Management OrganizationSociety for Clinical Research AssociatesSociety for Clinical Data Management____ systems are designed specifically to support clinical data management groups in carrying out tasks over multiple and simultaneous studies.Clinical Data ManagementGood Clinical PracticesGood Manufacturing PracticesClinical Trial ManagementA 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:CURRENT, CLOSED, DATA CHANGEOBSOLETE, CLOSED, DATA CHANGECURRENT, RESOLVED, INV VERIFYOBSOLETE, RESOLVED, DATA CHANGEAssertion: Coding is necessary. Reason: It required little space for storage on the database and made searching easier.Only Assertion is correctBoth Assertion and Reason are correct but Reason doesn't explain AssertionBoth Assertion and Reason are wrongOnly Reason is correctBoth Assertion and Reason are correct and Reason explains AssertionIn 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 -------------------Treatment PatternsTreatments > Active SubstancesStratificationTreatmentsTime is Up! 2 Comments maneeshs on January 7, 2020 at 9:03 am good one tough Reply Kiran on September 1, 2020 at 4:02 pm Ok Reply Submit a Comment Cancel replyYour email address will not be published. Required fields are marked *Comment Name * Email * Website Save my name, email, and website in this browser for the next time I comment.
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