Top 5 clinical Data Management Interview Questions ?
Clinical Data Management Interview Questions
- What is annotated CRF?
The annotated CRF is a blank case report form with markings or annotations that map clinical data collection fields used to capture subject data to corresponding Variables contained within the SDTM databases. FDA Recommends submission of CRF at the time of protocol submission.
- What is Clinical Data Management?
It is the process through which clinical data is collected, validated, reconciled, and archived as per GCP and regulatory requirements of respective countries.
- What is the importance of Clinical Data Management?
– Clinical data is very crucial, and it should be properly collected, CDM provides
- Data quality assurance
- Data integrity
- True representation of trial in study database
- Complete and accurate data collection
- Data loss protection
- Fastened development.
- Name few data bases used in CDM?
- RAVE, MACRO, CLINTRIAL, E-Clinical Suite, Oracle Inform.
- What is a protocol and its significance in CDM?
- A protocol is a written document that describes the objective , design , methodology, statistical considerations and organization of trial , it provides guidance to all the parties involved in the study like investigators , study coordinators , data managers and regulatory authorities.
6.What are the Phases in CDM ?
- These are the following Phases in Clinical data Management
- Setup Phase
- Conduct Phase
- Closeout phase