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Q1-2: Which modules of the DCTs are expected in those protocols (e.g. eConsent, Televisit, ePRO/eDiary, Wearable Device, Remote Monitoring…etc.)
题目来源
DCT Protocol Requirement Checklist
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DCT Studies PlanningQ1-1: Are there any upcoming protocols that include DCT designs?
Q2-2: Which countries do those protocols plan to include?
TelevisitQ1: What are the protocol requirements expected for Televisit other than those listed below?
Q2: Would you expect to use Televisit as standalone module in the study protocol or would you require Televisit coupled with ePRO/eDiary
Electronic Clinical Outcome Assessment (eCOA)Q1-1: Does the protocol contain eCOA?
Q1-2 Which of the following eCOA is expected in the protocol?
Q2: Of the eCOA planned to be used in the upcoming protocol, what is the preference of the eCOA device?
Q3: Which data formats are expected for eCOA data export?
Q4: Do your study protocols generally use licensed ePROs or publicly available ePROs? Please help to list down those commonly used ePROs in your study protocols.
Q5: For license required ePROs, what is your expectation on scope of service from Aurora in obtaining authorization from the author?
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