Five areas to investigate to determine whether your site is ready based on the 2016 FDA-OHRP guidance about eConsents.
This article highlights some of the monitoring challenges and burdens related to informed consent for a clinical trial and explains how electronic informed consent (eConsent) can positively impact monitoring practices and documentation. The article demonstrates how oversight of data integrity and human subject protection may be improved with an eConsent solution and provides some guidance on considerations when implementing eConsent in a clinical trial to enhance the monitoring process, including saving time, reducing costs and boosting efficiencies.
What can organizations – both in research and in technology – do to help define that future?
By eliminating paper source documents from their daily site operations, the clinical research facility has enhanced data sharing, reduced administrative headaches, and ensured, for their clients, high-quality data that meet ALCOA and other attributes as described by regulatory authorities and GCP.
Life science industry peers can share knowledge and strategies as they make adjustments and strive to establish new best practices and navigate necessary system changes.
EDC system enables CRO to take on a rescue trial that required the import of thousands of records from the previous system into the new one.
Navigate the process of EDC vendor selection and make a better-informed purchase decision on this key technology for clinical research.
Provide EDC users the benefits that are essential to successful clinical data management.
What to consider when making this important strategic decision.
When implementing a randomization and trial supply management (RTSM) system for a clinical trial, there is a shared responsibility between the RTSM vendor and sponsor organizations to ensure the system performs as intended according to predefined requirements.
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