We have developed several documents to be used within the SMA-TB project. From these, we have generated (as part of the SMA-TB Capacity-building toolkit) several templates which others can adapt and use for Project management monitoring and Clinical Trial Monitoring for their projects. This has been done in the context of SMA-TB WP1 (Task 1.1.) and WP4 (task 4.4.) The list of the templates included are: Templates for Project management: Deliverable template Standard Operating Procedure (SOP) template Word document template Templates for Clinical Trial Monitoring: Central Monitoring Report template Site Initiation Visit Checklist template Monitoring Site Visit Checklist template Monitoring Close-Out Site Visit Checklist and Report template Templates for Clinical Trial performance: Delegation of Responsibilities Log template Training Log template Screening Log template Enrolment Log template Investigational Medical Product Dispensing and Accountability Log template Serious Adverse Event Reporting form template Code Break Inquiry template Code Break Report template Meeting attendance template Protocol Deviation tracker template Informed Consent tracker template
Templates to be used in Project management and in Clinical Trial Monitoring
2021-11-26
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Elektronische Ressource
Englisch
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