HOW TO PREPARE AN INTERVIEW FOR CLINICAL DATA MANAGEMENT (CDM)

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How to prepare an Interview for Clinical Data Management (CDM)

INTRODUCTION

Clinical data management (CDM) is the collection and management of data in an effective and efficient manner for the purpose of clinical research. Clinical data management is being carried out to obtain high quality, error-free information and data from the clinical trials.

Clinical data management involves data collection, data storage, record keeping, data protection, destroying the data and sharing and reporting the data. 

The process of collecting and managing research data is done in accordance with the standards set by the regulatory authority such as GCDMP by Society for CDM, CDISC and 21 CRF Part 11.

IMPORTANCE OF CDM

Clinical Data Management plays a crucial role in clinical research.

  • Data quality assurance
  • Protection of data loss
  • Privacy and Security of data
  • Precise collection of data for Statistical analysis and reporting
  • Data integrity 

ROLES INVOLVED IN CDM

  • Data manager- Supervises the process of CDM
  • Database programmer or designer – performs CRF annotation, data validation, layout for data entry
  • Medical coder – Convert the obtained data into universally recognized medical codes
  • Clinical data analyst – Designs the CRF and develops discrepancy protocols
  • Quality control associate – Verify the accuracy of data and performs data audits
  • Data entry associate – Tracks the data from CRF pages and entered into a database
  • Clinical research associate – Serves as a go between the sponsors, trial participants and employees
  • Biostatistician – Conduct statistical analysis of the study
  • Medical Writers – Prepare the study reports

STAGES OF CDM

CDM process main objective is to give precise, valid and statistically sound data. The process starts even before the beginning of clinical trials.

1.Data Management Plan (DMP)

DMP document is the roadmap that describes CDM activities to be done throughout the clinical trials.

2.Case Report Form 

A CRF or e-CRF is a printed or electronic questionnaire for collection of data from the study participants.

3.Database Design

The data collected from the trial participants are will be entered in a CRF layout designed for data entry. The database screened with dummy data before the real data capture.

4.Data Collection

The data will be collected using CRF or e-CRF. In e-CRF, the chances of error are less.

5.CRF Tracking

The data entered in the CRF will be observed and checked by Clinical Research Associate (CRA) for the completion of CRF and given to the CDM team. The collected CRFs are tracked for the missing details, illegal data to obtain the standard data.

6.Data Validation

It is the process of testing the validity of data, its accuracy and integrity according to the protocol specification. Electronic edit checks, Source Data Verification (SDV), Data anonymization methods are used for the validation.

7.Discrepancy Management

Discrepancy management helps in cleaning subject data in CDMS and gathers evidence of the deviations observed in the data. It involves reviewing discrepancies, inquiring the reason and solving them with documentary proof or declaring as unsolvable.

8.Medical Coding

Medical coding helps in converting the reported medical terms into standard dictionary terms for the data consistency and to avoid data duplication. The dictionaries commonly used are MedDRA and WHODD.

9.Database Locking

The final data validation is run after a proper quality check and assurance. After all the data management activities are completed, approval for locking the database is obtained from all stake holders. Then the data is locked and extracted for statistical analysis.

SOFTWARES USED IN CDM

The commonly used software in CDM 

  • Oracle clinical
  • Clintrial
  • eClinical Suite
  • Rave
  • Macro
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