Clinical Data Management Assessment by ClinSkill | Oct 26, 2018 | 3 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, iii i, ii, iii iii, 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 REVIEW RECEIVED Either of these RELEASED A study can be locked only after First patient’s first visit Last patient’s first visit Last patient’s last visit First patient’s last visit 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: CURRENT, CLOSED, DATA CHANGE OBSOLETE, CLOSED, DATA CHANGE CURRENT, RESOLVED, INV VERIFY OBSOLETE, RESOLVED, DATA CHANGE Demographics, medical history and entry criteria fall under ______________ category. One record per patient None of the above One record per patient per visit Multiple records per patient per visit All of the above Metrics reporting is now a key function of the data management ________ Project manager Team Leader Both of these None of these Loading programs for lab data can be greatly simplified when a___________ is used. Short fat format Tall-skinny format Both of these None of these _______is carried out to ensure that the system rejects erroneous input in the proper ways. Test report Stress testing Test procedure script Test plan 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. Both Assertion and Reason are correct but Reason doesn't explain Assertion Both Assertion and Reason are correct and Reason explains Assertion Only Assertion is correct Both Assertion and Reason are wrong Only Reason is correct Assertion: Coding is necessary. Reason: It required little space for storage on the database and made searching easier. Only Assertion is correct Both Assertion and Reason are correct but Reason doesn't explain Assertion Both Assertion and Reason are wrong Only Reason is correct Both Assertion and Reason are correct and Reason explains Assertion Good Clinical Data Management Practices is published by Clinical Research Society Clinical Data Management Organization Society for Clinical Research Associates Society for Clinical Data Management 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 ------------------- Treatment Patterns Treatments > Active Substances Stratification Treatments ____ systems are designed specifically to support clinical data management groups in carrying out tasks over multiple and simultaneous studies. Clinical Data Management Good Clinical Practices Good Manufacturing Practices Clinical Trial Management The annual safety report should be submitted within __________of the end of the reporting year. 30 days 90 days 60 days 45 days If a study has 7 visits, then the termination type for Visit 1 that is defined when creating Events will be: Normal Termination Early Termination None of these Left Blank Close tracking of data entry means that performance measures can be Tracked Managed Both of these None of these The Unique Namespaces within Oracle Clinical that are created within the Global Library are called: Tables Views Domains CRF objects 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 True False The last step in the CRF development process, prior to sending CRF for programming is CRF version control Official ‘sign off’ Pre testing Data confidentiality Time's up 3 Comments SHIVANI BENAKATTI on December 1, 2021 at 9:13 am good Reply 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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