RSA-PACE study documents

Study summary

This web-page contains links to study documents and trial-specific training material.

Study documents

Clinical Investigation Plan (study protocol)

• RSA-PACE Clinical Investigation Plan V1.1 (11/07/24)

Participant information and consent forms

• RSA-PACE Participant Information Sheet V1.3 (11/07/24) English
• RSA-PACE Participant Information Sheet V1.3 (11/07/24) Welsh
• RSA-PACE Informed Consent Form V1.2 (11/07/24) English
• RSA-PACE Informed Consent Form V1.2 (11/07/24) Welsh

Other approved documents

• RSA-PACE Outpatient letter V1.0 (19/03/24) English
• RSA-PACE Outpatient letter V1.0 (19/03/24) Welsh
• RSA-PACE GP letter V1.0 (19/03/24)

Training material

Training videos

1. RSA-PACE protocol training, part 1 – Background
2. RSA-PACE protocol training, part 2 - Overview of the trial
3. RSA-PACE protocol training, part 3 - Recruitment & eligibility
4. RSA-PACE protocol training, part 4 - Randomisation & pacing
5. RSA-PACE protocol training, part 5 - Assessment methods
6. RSA-PACE protocol training, part 6 - Safety & breach reporting
7. RSA-PACE use of the Ceryx investigational device and tablet
8. RSA-PACE REDCap database - data entry

Training documents 

• Training Log
• Uscom instructions and training record V1.3
• Uscom Quick Reference Guide
• CRF Completion instructions
• REDCap Database Data Entry Guide
• Work instructions (order of actions during patient visits)
• Task checklist (tick boxes for actions during patient visits)
• Assessment timetable (schedule of events)