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Trial Documents

On this page you will be able to find all the documentation and manuals you will need to participate in the RACER study.

If you require support or localised documents then please contact the trial team and we will be happy to help.

Version LogLink opens in a new window

CRF Packs:

Other Documents:

1) Recruitment Pack - PurpleLink opens in a new window
Baseline QuestionnaireLink opens in a new window
Registration Form

Baseline Form Link opens in a new window

2) Imaging Pack - GoldLink opens in a new window
Imaging Form
Imaging Instruction Sheet

Imaging Manual Link opens in a new window

3) Day of Surgery & Randomisation Pack - Green Link opens in a new window
Randomisation and Day of Surgery Booklet
MAKO Robot Form
Surgery CRFLink opens in a new window

Surgery Manual Link opens in a new window

MAKO Knee CT Scanning ProtocolLink opens in a new window

4) In-Hospital Pack - Blue Link opens in a new window
 
In-Hospital Instructions
Post-Operative Pain Questionnaire

5) Discharge Pack - Orange
Discharge Instructions/ Booklet
Physiotherapy Manual (for clinicians)

Rehabilitation Booklet (for participants)

6) Learning Effect Pack - GreyLink opens in a new window
Learning Effect Patient Information Sheet
Learning Effects Consent Form
Day of Surgery Learning Effects Study Instructions
MAKO Robot Form (You can download this from the Day of Surgery Pack)
Learning Study Surgery FormLink opens in a new window

7) Unscheduled Events Pack - Red Link opens in a new window

Withdrawal Forms (Main and Learning Effect Sub-study )
Notification of Death
File Note
Protocol DeviationLink opens in a new window
Adverse Event Link opens in a new window
Serious Adverse Event Forms (Initial Event Link opens in a new window & Follow-upLink opens in a new window )

Serious Adverse Event Evaluation FormLink opens in a new window

Serious Adverse Event Continuation FormLink opens in a new window

All CRF Packs

Follow-up Questionnaires

Six Week EQ5D-5L Questionnaire Link opens in a new window

3-Month Follow-up QuestionnaireLink opens in a new window

6-Month Follow-up QuestionnaireLink opens in a new window

12-Month Follow-up QuestionnaireLink opens in a new window

24-Month Follow-up QuestionnaireLink opens in a new window

5-Year Follow-up QuestionnaireLink opens in a new window

10-Year Follow-up QuestionnaireLink opens in a new window

Other

Blinded Operation Note TemplateLink opens in a new window

Delegation LogLink opens in a new window

Delegation Log - Responsibility Codes Link opens in a new window

Eligibility CriteriaLink opens in a new window

Note to FileLink opens in a new window

Notification of DeathLink opens in a new window

Operation NoteLink opens in a new window

Patient ID CardLink opens in a new window

Protocol Deviation FormLink opens in a new window

Screening Log

Patient Contact Details Link opens in a new window

Study Summary SheetLink opens in a new window

Other Documents Pack (All above)