Training Resources

Training Presentations

1. Introduction
2. Identifying Participants, Screening, Eligibility
3. Randomisation
4. Unblinding
5. Visits
6. Assessments including Working Practice Guidelines
7. Concomitant Medications
8. Source Data
9. Lab Samples
10. IMP Prescribing and Administration
11. Data Collection and Data Entry
12. Discontinuation, Withdrawal and Completion
13. Adverse Event Recording and Reporting
14. Protocol and GCP Breaches
15. Pharmacy TRuST IMP Accountability
16. Pharmacy IMP Preparation

SIV Presentation

SIV Pharmacy/Unblinded team Presentation

Laboratory manual

Pharmacy manual

Randomisation flowcharts

Other Resources

UK sites Protocol

Spanish sites protocol

Castor eCRF

TRuST Randomisation

Breach reporting

SAE reporting

Participant Information Sheet Template

Spanish Participant Information Sheet

Catalan Participant Information Sheet

Brief Participant Information Sheet Template

Castor Data Entry Guidelines

Castor Training

Data Worksheet for eCRF Training

SIV Monitors

Continuation Sheets

CS Unscheduled Visit

CS Visit 1

CS Visit 2

CS Visit 3

CS Visit 4

CS Visit 5

CS Visit 6

CS Visit 7

CS Visit 8

CS Visit 9

Data Worksheets

DW AE Log

DW Completion of Trial/Early Withdrawal

DW Concomitant Medication Other

DW Concomitant Medication Respiratory

DW Discontinuation of Trial Medication

DW Exacerbation Form

DW Unscheduled Visit

DW Visit 1 Screening

DW Visit 2 Baseline & Randomisation

DW Visit 3

DW Visit 4

DW Visit 5

DW Visit 6

DW Visit 7

DW Visit 8

DW Visit 9