Data Safety and Monitoring Board (DSMB) meetings
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Organization and minuting of DSMB meetings
Final Stewardship Plan
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Stewardship plans outline how to achieve the optimal use of an intervention, including, for example, how to avoid irrational use, overuse or abuse of health technologies.” A final plan will be made availabe in M12
Clinical Trial Report
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This is the report of the clinical activities and will include the end of follow up report of both mothers and infants.
Stewardship plan
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Stewardship plans outline how to achieve the optimal use of an intervention, including, for example, how to avoid irrational use, overuse or abuse of health technologies.” A draft plan will be made available in M6.
Updated plan for the exploitation and dissemination of results including communication activities
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We will reassess our previous developed Plan for the exploitation and dissemination of results including communication activities for compliance with Horizon Europe requirements. An updated version will be available at M6
Collection of documents related to the status of the clinical trial
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deliverable Provision of EDCTP2 project documents to be shared as background information. These include:-Initial study package of Pyrapreg-Final version of study protocol-Ethical approvals-Data and Safety Monitoring Board reports-Publications
Master Degrees (2)
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Two Masters students have completed their training.
Maternal Safety Report
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Report on maternal AE, AESI and SAE
Networking Progress Report
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List of updates in the dissemination tools.
PhD Degrees (2)
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Two PhD students have completed their PhD training
Trail Steering Committee (TSC) meetings
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Organization and minuting of TSC meetings
Updated Data Management Plan
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The MRC-The Gambia of LSTMH is responsible for the data management of the project. A data management plan (DMP) has been put in place under EDCTP 2. An updated DMP will be made available at M6.
Study final report
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This is the overall report of the entire study including all the different work packages.
Final report
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Report describing the final outcomes of the project as per EU regulations
Population PK Report
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Summary report on the population PK and PKPD modelling of pyronaridine in pregnant and non-pregnant malaria patients, including pregnancy effects and exposure-response analysis
Report on the status of posting results
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Report on the posting of summary trial results in the applicable registry/ies (where the study was registered).
Infant Safety Report
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Safety outcome after one year.
Global Access Plan
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Proportional global access plan describing potential registration and access items
