Stroke Oxygen Study

SO2S Study Forms

Information for patients (vs4) 
Information for legal representatives/relatives (vs4) 
Consent form for patients (vs5) 
Consent form for legal representatives/relatives (vs5)
Consent confirmation (vs5)
Independent physician consent (vs1)
SO2S GP letter (vs3)

Please note that all above forms must be printed on headed paper from the hospital of the local PI and have contact details of the local PI.

Case Record Form (CRF) includes Randomization, 1 week follow-up, SAEs, Death
SO2S consent/randomization sticker for notes
Screening log

Discharge and Readmission form


Forms for Central Follow-up


3 months follow-up questionnaire
6 months follow-up questionnaire
12 months follow-up questionnaire

 

Consent Forms (Word format)

Consent form for legal representatives/relatives (vs5-Word)

Consent form for patients (vs5-Word) 

Consent confirmation (vs5-Word)

Case Record Form (CRF-Word)

Independent Physician Consent (Vs1-Word)

 

Amendment Summary

Please click on these links to download the pdf versions of these documents with tracked changes highlighted for your R&D approval.  If you require versions with tracked changes accepted, i.e. to use with patients, please use the links above

3 month questionnaire (Amendment 2 - July 2012)

6 month questionnaire (Amendment 2 - July 2012)

12 month questionnaire (Amendment 2 - July 2012)

Name of hospital for continuing care hospital has been added. Addition of a question regarding eyesight.

SOS CRF (version 1 amendment 4 July 2012 this has superseded version 1 amend 3, Aug 2009)


Randomisation form
- Format of date reminders has been changed to DD-MON-YYYY from DD-MM-YYYY

Step 7 (Contacts) has now become step 5 and has more detail as to likely or preferred location for week-1 follow-up

Step 5 (Consent) has now become step 6

Step 6 has now become step 7 (Randomisation) with updated telephone numbers.

-   Week 1 assessment form

‘Control’ option has been removed from ‘Record of oxygen saturation and treatment during the first 3 days’ section. As either the oxygen is in place or not.

Addition of discharge details, a Pre-Stroke Rankin and EQ-5D to be completed by the researcher.

-   Serious Adverse Event Notification form

Suspected treatment has been removed.

Request for re-admission information has been added to section B.

Discharge and readmission form

This is a new form and must be completed online when a patient is discharged and readmitted.

Patient consent form (version 5 July 2012 this has superseded version 4, Aug 2009)

-    “and data collected during the study, may be looked at by individuals from the Stroke Oxygen Study, from regulatory authorities or from the NHS Trust, where it is relevant to my taking part in this research” replaces “may be looked at by responsible members of the research team or by members of the data monitoring committee”.

Relative, carer or independent legal representative consent form (version 5 July 2012 this has superseded version 4, Aug 2009)

-    and data collected during the study, may be looked at by individuals from the Stroke Oxygen Study, from regulatory authorities or from the NHS Trust, where it is relevant to my taking part in this research” replaces “may be looked at by responsible members of the research team or by members of the data monitoring committee”.

Patient confirmation of consent form (after recovery) version 5 July 2012 this has superseded version 4, Aug 2009)

-   and data collected during the study, may be looked at by individuals from the Stroke Oxygen Study, from regulatory authorities or from the NHS Trust, where it is relevant to my taking part in this research” replaces “may be looked at by responsible members of the research team or by members of the data monitoring committee”.

Independent Physician Consent Form (version 1 July 2012)

-   This is a new consent form for an independent physician to consent on behalf of the patient.  Please note this is subject to local trust policies as to whether this can be used, contact your local R&D department if you are not sure.