Resources
Please follow the links below to our online systems and breach report form
- TRuST – Randomisation or Emergency Unblinding
- Castor Data Management System – eCRF
- Tayside Pharmacovigilance System – SAE reporting
- Breach Reporting Form – TASC SOP59
Templates
TASC SOPs
- TASC SOP11 – Identifying, Recording and Reporting AEs for CTIMPs
- TASC SOP59 – Reporting Breaches in Clinical Research
Training Presentations
- Introduction
- Identifying Participants & Eligibility Criteria V3
- Randomisation
- Emergency Unblinding
- Visits
- Assessments including Working Practice Guidelines
- Concomitant medications
- Source Data
- Laboratory Samples
- IMP Management and Accountability
- Data Collection Data Entry
- Risk and Adverse Events Overview
- Breach Reporting
- Discontinuation, Withdrawal, Completion
- AM11 Summary
Manuals and User Guides
- Laboratory Manual V6
- Pharmacy Manual V4
- Castor User Guide – Data Entry Guidelines
- TRuST User Guide
- Pharmacovigilance Database User Guide
Protocol and Participant Materials
- Protocol V6
- Brief Participant Information Sheet – Template
- Participant Information Sheet V7-Template
- Informed Consent Form – Template
- GP Letter – Template
- Invite Letter (Clinic and GP) – Template
- Invite Letter (Database) – Template
- Advert Poster – Template
- CMR Sub-study Participant Information Sheet
- CMR Sub-study Informed Consent Form
- CMR Sub-study GP Letter
Continuation Sheets
Worksheets
- Visits Dates Calculator
- Adverse Events
- Concomitant Medication
- Hypoglycaemic Events
- Diabetic Ketoacidosis (DKA) Events
- Eligibility Form V3
- Blood Glucose and Ketones Diary
- Insulin Dose Diary
- Discontinuation of Trial Medication
- Completion/Early Withdrawal
- Visit 1 V3
- Visit 2 V1
- Visit 3 V3
- Visit 4 V2
- Visit 5 V2
- Visit 6 V2
- Visit 7 V2
- Visit 8 V2