Trial Resources For Research Staff

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

• Breach Log V1
• Delegation Log V1
• Sample Log V2
• Training Log V1

TASC SOPs

• TASC SOP11 – Identifying, Recording and Reporting AEs for CTIMPs
• TASC SOP59 – Reporting Breaches in Clinical Research

Training Presentations

1. Introduction V1
2. Identifying Participants & Eligibility Criteria V3
3. Randomisation V2
4. Emergency Unblinding V2
5. Visits V2
6. Assessments including Working Practice Guidelines V2
7. Concomitant medications V2
8. Source Data V1
9. Laboratory Samples V2
10. IMP Management and Accountability V1
11. Data Collection Data Entry V1
12. Risk and Adverse Events Overview V2
13. Breach Reporting V1
14. Discontinuation, Withdrawal, Completion V2
15. AM11 Summary V1

• SIV Monitors Presentation Slides

Manuals and User Guides

• Laboratory Manual V6
• Pharmacy Manual V4
• Castor User Guide – Data Entry Guidelines V1
• TRuST User Guide V1
• Pharmacovigilance Database User Guide V5

Protocol and Participant Materials

• Protocol V6
• Brief Participant Information Sheet V1 – Template
• Participant Information Sheet V7-Template
• Informed Consent Form V4 – Template
• GP Letter V2 – Template
• Invite Letter (Clinic and GP) V1– Template
• Invite Letter (Database) V1 – Template
• Advert Poster V1 – Template
• CMR Sub-study Participant Information Sheet V1
• CMR Sub-study Informed Consent Form V1
• CMR Sub-study GP Letter V1

Continuation Sheets

• Visit 1
• Visit 2
• Visit 3
• Visit 4
• Visit 5
• Visit 6
• Visit 7
• Visit 8

Worksheets

• Visits Dates Calculator V1
• Adverse Events V1
• Concomitant Medication V2
• Hypoglycaemic Events V1
• Diabetic Ketoacidosis (DKA) Events V1
• Eligibility Form V3
• Blood Glucose and Ketones Diary V1
• Insulin Dose Diary V1
• Discontinuation of Trial Medication V1
• Completion/Early Withdrawal V1
• Visit 1 V3
• Visit 2 V1
• Visit 3 V3
• Visit 4 V2
• Visit 5 V2
• Visit 6 V2
• Visit 7 V2
• Visit 8 V2