There are many ways in which databases are used for health projects and programs. Health information must be collected and analyzed to support the development of drugs, to ensure that regulatory guidelines are being followed, and much more.
Database management is an essential part of clinical research and involves a team of people that must be coordinated. Here is a general introduction to managing databases for clinical research.
Use Your Clinical Research Training to Plan
In order to ensure that a database contains the necessary information for a project, a team with clinical research training must collaborate on how it will be built. Whether the data collected will be used to monitor or evaluate healthcare programs, or conduct clinical trials, a plan must be established first.
In clinical research database management, researchers must work as a team
Experts have noted that conversations about data protocol, terminology, and parameters can be too complicated to work through via emails, so planning should be done in person or over the phone. The fields of the database and methods for collecting data must be clear, and the team must agree on how oversight will be handled. For the database to maintain structural integrity, the team members must all be on the same page.
Risk Management and Documentation
In addition to assessing and evaluating programs or projects, a clinical research coordinator career may involve assessing components of those programs including their databases. Before a database can be used, it must be tested. Typically this is done with something called “dummy data,” which allows clinical research personnel to assess potential risk indicators and set thresholds for those indicators. For example, how long does it take between data collection and data entry, and what is the maximum allowable timeframe between these two tasks?
Following the collection of data, processes for database management should also be documented. The statistics produced by studies or the way in which a database was built may be required for further research, to conduct an audit, or as a model for another study. The more information about methodology and results you document, the better.
As with any kind of collaborative work, throughout the process of building and maintaining a database, there must be clear communication protocols. As indicated above, a database will function better, carry less risk of error, and be more valuable for future study when all collaborators are able to communicate with each other about processes involved in data collection, entry, and analysis.
Databases should be built with the future in mind
Beyond clinical researcher personnel, this extends to the organizations, programs, or project leaders who may be involved in database related work. If one organization is doing the database management for an organization responsible for collecting data, then the protocol for status reports, or access, should be established and necessary information should be available for all parties involved. Good database management means that audits are easier, improvements are possible, and discrepancies are minimized.
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