Published November 26, 2021
| Version 1
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Templates to be used in Project management and in Clinical Trial Monitoring
Creators
- 1. IGTP
- 2. PHRU, WHC
- 3. NCTLD
- 4. CRA
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
- 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
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