Patient Reported AE’s using eDiary Technology

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Recently assisTek authored an article published by the Society of Clinical Data Management’s “Data Basics”.

The article discusses the benefits of assessing AE’s in real time when the symptoms are experienced by the subject (versus during site visits only) and how the data can be integrated into existing clinical databases (including EDC).




Electronic Adverse Event Reporting and Follow-up

Patient safety has never been more important than it is today in Clinical Trials.

assisTek has built an infrastructure to support the collection of patient and clinician reported adverse events, all electronically.  Emphasis has been placed on what matters most – accurate and timely reporting of symptoms, proper notification to the study team and immediate access to data.

Two relevant examples of how symptoms are captured, team members are notified, and data is updated are below:

Patient eDiary Example:  Patient reports potential Adverse Events from home, Study Team is instantly notified and has access to data for follow-up & updates.

Direct Clinical Data Capture Example:  Clinician collects Adverse Events from patient, Investigator is instantly notified and has access to data for follow-up & updates.

Contact assisTek to understand how your study can benefit. (and yes, we will reply!)

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