Published November 26, 2021 | Version 1
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Templates to be used in Project management and in Clinical Trial Monitoring

Description

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 
    • Project impact report 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

Files

Files (1.2 MB)

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Additional details

Funding

SMA-TB – A novel Stratified Medicine Algorithm to predict treatment responses to host-directed therapy in TB patients. 847762
European Commission