On this page you will find all relevant documents and resources for setting up and conducting the trial at site.
To help you with this, please find a version control log listing all of our documents here. If you wish to print these documents to create a paper ISF, please find an index here.
Thank you to all of our sites for your hard work so far. Please find a certificate of appreciation here.
Substantial amendment #1
- REC Approval
- Updates to documents:
- Participant Follow-up CLMHD Letter V1.0 26Oct2020
- Participant Workbook Letter V1.0
- Participant Consent Form v3.0 29Oct2020
- Participant Interview Consent Form V3.0 04Dec2020,
- Participant Information Sheet v3.0 29Oct2020,
- Participant Interview PIS V3.0 27Oct2020,
- Practitioner Interview PIS V3.0 29Oct2020,
- Protocol v3.0 20201029.
Non-substantial amendment #1
Site Training Slides
CRN Letter Site Targets
SAE Handling Process Working Instruction