Novel Methods and Regulation on Electronic Data Collection in Clinical Trials FE01-FE03
Dr. Syed Mujtaba Hussain Naqvi,
Global Generics India, Ameerpet, Hyderabad, Telangana, India.
The data collection is a pivotal part of clinical studies and impacts how the data is managed and analysed and the outcome of the clinical research besides contributing to the cost and duration of the clinical studies. Paper based method is a common method for clinical research data collection, because of certain advantages of paper over computer based approaches. The use of multicenter trials with centers across the globe strongly benefits from electronic data systems for the effective management in the collection and transfer of data. Online data collection utilises internet to enter data from the clinical study site to a central database. Novel convenient handheld devices are used in clinical research to record and process data especially in field studies and self reporting data collection processes. Personal Digital Assistants (PDA) and tablet personal computers (Tablet PC) allow real time data collection at the point of care in clinical studies. There are technical issues which need to be considered in Electronic Data Capture (EDC). The Indian Good Clinical Practice (GCP) gives guidelines on electronic data collection and Food and Drug Administration (FDA) describes the regulation in 21 Code of Federal Regulations (CFR) regarding electronic data collection.