HAP Submission package
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A Submission package, prior to enrolment of first participant, containing the final version of the clinical trial protocol as submitted to regulators, a registration number of the clinical trial in a WHO or ICMJE-approved registry (e.g. the EU Clinical Trials Register) and approvals from ethics committees and national competent authorities if applicable; the deliverable will be updated with the approval packages of all trial sites once the last approval has been received
Quality and risk Management
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Risk Management Plan
Dissemination, Communication and Exploitation plan
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Project Exploitation, Dissemination, Communication plan description. Updated throughout the project.
CAP Submission package
(öffnet in neuem Fenster)
A Submission package, prior to enrolment of first participant, containing the final version of the clinical trial protocol as submitted to regulators, a registration number of the clinical trial in a WHO or ICMJE-approved registry (e.g. the EU Clinical Trials Register) and approvals from ethics committees and national competent authorities if applicable; the deliverable will be updated with the approval packages of all trial sites once the last approval has been received