Project Manual - CoBraD RWD, Updated MES-CoBraD Protocols and Quality and Quantity (Q&Q) Evaluation - v1

This deliverable will Provide the updated specific characteristics of the populations tobestudied and the specific data from these populations tobeacquired The purpose is to have an agreement between research participating organisations and community stakeholders on the utility and acceptability of RWD to be used in future analyses by respecting medical ethics values autonomy beneficence nonmaleficence justice and containing the approvals of Pilot organisations IRBsdefine the final updated protocols to be pursued as part of data acquisition sharing and information dissemination after receiving input from stakeholders and oversight by the External Advisory Board The purpose is to have an agreed upon protocol on the acquisition and handling of RWD that will be the basis for the threeyear research and innovation plandefine the critical elements all data should have to be considered of high acceptable quality as well as the amount of data necessary to achieve the overall project objectives