Database Management in Healthcare
Firstly we will try to understand what is Clinical Data Management (CDM)?
Clinical data management (CDM) is the process of collecting and managing research data in accordance with regulatory standards to obtain quality information that is complete and error-free. The goal is to gather as much of such data for analysis as possible that adheres to federal, state, and local regulations.
The field of Database Management in Healthcare has come about due to demands from both the pharmaceutical industry and the regulatory authorities. As the drive to “fast-track” the development of pharmaceutical products continues to accelerate, regulatory entities have responded by requiring quality-assurance standards to be met in collecting the data used in the drug evaluation process.
Two such standards created by the Clinical Data Interchange Standards Consortium (CDISC) are particularly vital to Clinical Data and Site Management: the Study Data Tabulation Model Implementation Guide for Human Clinical Trials (SDTMIG) and the Clinical Data Acquisition Standards Harmonization (CDASH). The former is currently mandated for use by the U.S. Food and Drug Administration (FDA). The latter created a standard format for collecting data across studies so that data submissions can be more easily tracked and reviewed.
Specialized software applications are used in Clinical Data & Site Management to create audit trails that allow discrepancies to be minimized even in large and complex clinical trials. Examples include Oracle Clinical, Rave, eClinical suite, Clintrial, and Macro. Clinical data management systems (CDMS) are especially vital in trials conducted across medical centers in which an enormous amount of data is produced.
How Does Clinical Data Management (CDM) Work ?
To maintain the integrity of data, the Clinical Data Management process starts at the very beginning of a clinical trial, even before the study protocol is finalized. The Clinical Data Management team designs a case report form (CRF) and defines the data fields to be utilized. CRFs specify the type of data to be collected, the units of measurement to be used, and CRF completion guidelines (i.e., instructions for filling in data). Variables are annotated using coded terms.
A Database Management in Healthcare is then developed as a guide, including a description of the trial’s Clinical Data Management activities. Databases are built to support Clinical Data Management tasks with corresponding compliance tools. Testing is done before using the plan with actual clinical trial data. CFR tracking, data entry, validation, discrepancy management, medical coding, and database locking are subsequent steps in the process.
Case report forms may be used to collect data by paper or electronic means; however, as technology has continued to evolve, the trend towards electronic data collection has followed suit. Furthermore, remote data entry or e-CRF has been adopted by many pharmaceutical companies as a time-saving measure.
What Roles Are Involved in Clinical Data Management?
Clinical Data & Site Management requires a variety of roles and responsibilities of team members and take the form of: Data manager – supervises the Clinical Data Management process
Database programmer or designer – performs the CRF annotation, creates the study database, enables data validation, designs data entry screens, and performs edit checks using dummy data
Medical coder – codes variations such as adverse events and medical history
Clinical data coordinator – designs the CRF, prepares the filling instructions, develops discrepancy protocols
Quality control associate – checks the accuracy of data entry and performs data audits
Data entry associate – tracks the receipt of CRF pages and enters data into a database.
