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Stroke Oxygen Study |
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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 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).
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