Top Clinical Data Management Interview Questions & Answers | Clinoxy

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CDM is the process of collecting, cleaning, and managing clinical trial data to ensure it is accurate, reliable, and ready for analysis

It ensures that the clinical trial data is error-free and meets regulatory standards for drug approval.

A CRF is a document used to collect all data from each patient participating in a clinical trial.

An electronic Case Report Form (eCRF) is a digital version of the CRF used in Electronic Data Capture (EDC) systems.

An EDC (Electronic Data Capture) system is software used to collect and manage clinical trial data electronically.

Medidata Rave, Oracle Clinical, Inform, Veeva, and ClinCapture are commonly used.

Data validation ensures that the data entered is logical, consistent, and within the expected range.

A DVP is a document that outlines all the edit checks and validation rules for a study.

It involves identifying discrepancies in data and sending queries to sites for clarification or correction.

It is the final step in CDM where no further changes can be made to the data before analysis.

Data cleaning is the process of detecting and correcting inaccurate or incomplete data.

It is the process of reviewing and resolving inconsistencies found in clinical trial data.

Validation checks if the data makes sense; verification ensures that the data matches the source.

Edit checks are programmed rules that identify inconsistent or missing data in the database.

It ensures that all Serious Adverse Events recorded in clinical data match the safety database.

It’s a method of entering data twice by different operators to minimize entry errors.

It is the process of aligning data from various sources to a consistent format for analysis.

CDISC (Clinical Data Interchange Standards Consortium) develops global data standards for clinical research.

SDTM (Study Data Tabulation Model) organizes raw data; ADaM (Analysis Data Model) prepares data for statistical analysis.

An audit trail tracks every change made to the data, showing who made it and when.

Good Clinical Data Management Practices (GCDMP) are standards ensuring data quality and integrity.

They are FDA regulations governing the use of electronic records and electronic signatures in clinical research.

Raw data is unprocessed data directly from the source; clean data is validated and ready for analysis.

It is the transfer of clinical data from one system to another while ensuring data integrity.

Data listings are detailed tables showing collected data for review and verification.

It involves creating the data structure, variables, and forms to capture trial data efficiently.

Metadata are data about data — such as variable names, formats, and units.

Data archiving is the secure storage of all study data and documents after trial completion.

It defines how data will be exchanged between parties like CROs, sponsors, or labs.

Attention to detail, knowledge of EDC tools, understanding of GCP, and analytical thinking are essential.