Everyone is talking about Big Data and no matter the industry is, it is part of each sector, including the clinical research area too. But big data is nothing without a methodology of managing this data. This is exactly what Clinical Data Management is all about. And of course, it includes many strict regulations, because we need to ensure not only the integrity of study results but the quality and safety of clinical trial participants as well.
Clinical Data Management is a set of rules about how to store the information about a certain clinical research project in the most adequate and proper manner. It also represents a structure of programmes and tools – the so called Clinical Data Management Systems (CDMS) – which makes the process much simpler, or easy if you know how to use them.
NB! If you want to evaluate your Clinical Data Management knowledge, you can try this free short test here (https://crotraining.co.uk/webinars/clinical-data-management-advanced-edc-systems/)
Needless to say, it is not only about making data easy to track. The most important task of the Good Clinical Data Management Practices (GCDMP) created by the Society for Clinical Data Management (SCDM) is to ensure the delivery of an error-free database in the end of the clinical trial. Those who are directly responsible for collecting data and safely distributing it among other members of stuff involved in the project, are the members of the Clinical Data Management Team. They include:
- Data Manager
- Database Programmer/Designer
- Medical Coder
- Clinical Data Coordinator
- Quality Control Associate
- Data Entry Associate
This means that every organization needs to have its own team with sufficient experience and skills in order to handle the clinical data successfully. The global challenge for the regulators is to make sure that the Clinical Data Management standards are the same across the different institutions and are able to be monitored at any time, so that we can prevent future failures or fatal mistakes.
What do you think of the current Clinical Data Management Standards and do you have any recommendations for improvement? I will be happy to hear more about your suggestions and please join us on our live next month webinar , where we will be able to not only hear some advanced insights from the CDM but also to discuss the future of the regulations and new systems.
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