Clinical data management (CDM) involves in all aspects of clinical data processing, right from data collection and organization to making it available in structured and accessible format. It’s all about providing the right information to the right people at the right time. Advanced technologies and processes are available to collect, sort, organize, and evaluate clinical data. When it comes to clinical research, the process involves collecting, cleansing, and managing trial data, which is crucial to get reliable, statistically valid data from the clinical trial. Researchers need to acquire, store, and report on clinical research data in keeping with HIPAA regulations.
The main activities involved in managing data for clinical research are:
Database design: While designing a database, details like objectives, intervals, visits, investigators, sites, and patients are defined and tested.
Data collection: Data capture can be accomplished with case report form (CRF), which is available either in paper or digital format. Data are manually entered into the system whereas data from digital forms can be used directly. Usually, double data entry is performed.
Data validation: After the data is entered, it is verified for transcription errors and discrepancies. Discrepancies which may occur due to deviations from the protocol, missing data, inconsistent data, or range checks, are highlighted.
Discrepancy management: Discrepancy management includes reviewing discrepancies, investigating its reasons, and resolving them with documentary proof. If the team can’t find any solution to the discrepancy, it will be declared as irresolvable.
Medical Coding: Coding (using MedDra, WHO-DDE for coding medications) for the clinical study is done as based on the project specific protocol requirement.
Database locking: When all the data management activities are complete, the database is locked and the cleansed and verified data is extracted for the analysis.
CDM has evolved into a standard clinical research entity and is evolving rapidly with the demand for pharmaceutical companies to fast-track the process of drug development, and drug evaluation.
Professionals who perform CDM have the knowledge needed to maintain the quality standards of processes and provide clean, accurate data in a usable format, in a timely manner.