Presentation

My eClinical is our application dedicated to clinical studies. This application exists as a Web form but can be proposed, on demand, as a mobile application (directly downloaded by the investigators or patients of the study thanks to a specific QR code present on the documents of the study or any other support). The receipt of reports of serious adverse events is done in a dedicated database, managed by the sponsor of the study.

My eClinical is intended for any investigator taking part in a clinical study, and wishing to report to the Promoter a serious adverse event directly from his / her workstation. The declarations are transmitted in a dedicated database. They can then be directly imported into the Promoter's pharmacovigilance database.

My eClinical can be set at the Promoter's request, depending on the chosen study. The application will be made available to the Investigators by the Promoter, and an electronic signature system will identify the Investigator taking part in the study.

Two remarks :
• At the level of the European Commission, My eClinical allows Investigators to meet their obligation to report serious adverse events « In a very short time, in no case should it exceed 24 hours after knowledge of the serious adverse event » (Communication from the Commission - Detailed guidance on the establishment, verification and presentation of adverse event / adverse event reports based on clinical trials of medicinal products Human Use Guideline "CT3" of the European Commission / Section 4.3.1 / Article 29).

• In France, My eClinical is part of the data dematerialization process initiated by the ANSM : « statements SUSARs, which were previously sent by the clinical trial sponsors to the ANSM by post or by fax, will now be sent by email only ».

We would like to thank in advance all the CROs and other institutions that have shown their interest and support for this new type of application.

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