Clinical Data Management Interview Question Part 1
- 1. Interview Preparation Questions Clinical Data Management PART-1
- 2. INDEX 1 2 3 4 5 1.Define CDM. 2.What is the importance of CDM? 3.What are the different databases used for CDM? 5.What is the protocol? Explain its importance in CDM. 4.What are the different phases of CDM?
- 3. CDM is a process in which the clinical data is collected,validated, reconciled and archived as per GCP and applicable regulatory requirements. Define Clinical Data Management.
- 4. Clinical research studies provide crucial information. Clinical data management provides: •Assurance of data quality •Accelerated development •Protection from data loss •Complete and accurate collection of data •Assurance of data integrity and quality during database transfer •True representation of the trial in the study database What is the importance of CDM?
- 5. Commonly used CDM tools are 1.ORACLE CLINICAL, 2. CLINTRIAL, 3. MACRO, 4. RAVE, 5. eClinical Suite. • In terms of functionality, these software tools are more or less similar and there is no significant advantage of one system over the other. What are the different databases used for CDM?
- 6. Three phases in CDM – • Setupphase • Conductphase • Closeoutphase 1. Set-up phase–Set up phase will contain protocol review,CRF design and edit check,auto query,and creation testing of edit check. 2. Conduct phase–The conduct phase will contain data entryand discrepancy management, lab recollection, SAE reconciliation, and medicalcoding. 3. Close-out phase – Theclose-outphasewillcontainfreezing, locking,andunlocking. What are the different phases of CDM?
- 7. •A Protocol is a document that describes the objective(s),design, methodology,statistical considerations,and organization of a trial. • Protocol serves as a comprehensive document that provides guidance for all parties involved in the research process, including investigators, study coordinators, data managers, and regulatory authorities. Here's why protocols are important in CDM: •The protocol defines the study design,including the research questions, hypothesis, and objectives. It outlines the study’s specific aims and provides a clear road map for data collection and analysis. What is the protocol?Explain its importance in CDM.