Stroke Oxygen Study

SO₂S Study Forms and Procedures

Please note new version of consent/ patient/ legal rep. information and GP letter 26.06.2008. Please replace all old forms by the new versions (below). The latest minor amendment was done on 15. 12.2008 (change of office address and telephone numbers, applies to all forms).

Information for patients (vs4) generic (all centres) headed (Stoke only)

Information for legal representatives/relatives (vs4) generic (all centres) headed (Stoke only)

Consent form for patients (vs4) generic (all centres) headed (Stoke only)

Consent form for legal representatives/relatives (vs4) generic (all centres) headed (Stoke only)

Consent confirmation (vs4) headed paper generic (all centres) headed (Stoke only)

SO₂S GP letter (vs3) generic (all centres) headed (Stoke only)

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 Serious Adverse Event (SAE) report form

SO₂S consent/randomization sticker for notes

Delegation log

Click here to randomize a patient to the SO₂S Study

Standardized Operating Procedures (SOPs)

SOP for eligibility to take consent from a patient or legal representative

SOP for determining competence to give consent

SOP for Serious Adverse Events (SAEs) and SUSARS

Forms for Central Follow-up

3 months follow-up questionnaire

6 months follow-up questionnaire

12 months follow-up questionnaire

How to get a password and login to the randomization and data entry portal

Complete Delegation Log and email to the trial coordinator. Keep signed original of the form in the site file. We will pass this information on to the Trials Management System at the Birmingham Clinical Trials Unit who will enter names and details of each investigator onto the web management database.

Once your name has been entered you can request a login and password using the following procedure:

1. Click here to get to the site. First Request a user name by clicking on 'send me a username' using your email address.

2. Click here to get back to the site. Request authorization to set or change password. using your email address and user name.

3. Follow instructions in the email and on screen.

Click here to enter the SO₂S data randomization and data entry development site (accessible to staff only).