Tagged: safety review
April 18, 2022 at 9:34 pm #4580Jane Marie JohnsonParticipant
I would appreciate forum member input on this scenario:
The EDC system is designed to send out “auto notifications” to trial sites if a data point indicates additional testing MAY be required. The data point in question is a safety parameter required as part of a mandated Post Approval Study. The sponsor is copied on these auto-notifications and does a review to determine if additional action is indeed required. The sponsor documents the outcome of the review and with a reply to the email. The email is just documentation for potential future reporting and to show prompt oversight. The TMF does NOT store email communications; emails are not stored in the zone specific section but instead all stored in a central repository.
Best place to file the response the the email?
07.02.04 To organize critical data around a special event of interest, one that is of scientific and medical concern specific to the product or program. Usually requested by or submitted to Regulatory Agencies. Reports may include but are not limited to specific regulatory forms and supporting data, reporter correspondence, associated note-to-files, source documentation, case logs, narratives, case unblinding forms and/or safety database case printouts.
07.01.02 Listing of trial data for a single study trial used for a variety of safety evaluation of the investigational product purposes (e.g. Serious Adverse Events (SAE) case listings, database line listings, etc.). Note: for this artifact, Column J (ICH review) references 5.16.1 The sponsor is responsible for the ongoing safety evaluation of the investigational product(s).
Thank you in advance
April 28, 2022 at 5:42 pm #4591Vaibhav FundeParticipant
Best place to file such communication is “07.02.04 – Special Events of Interest. As per above information EDC generated notification required corresponding communication from sponsor which suits this artifact defination.
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