Stroke Oxygen Study

Instructions and Standard Operating Procedures (SOPs)

Please read these instructions carefully. They will help you comply with GCP. Please use forms below for documentation of trial procedures.

1. SOPs

SOP for Safety Reporting

SOP for dealing with a breach of Protocol

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

SOP for determining competence to give consent


2. Information sheets relating to trial procedures

How to use SOPs

Acknowledgement of new documents or document versions

Validation of equipment

Tracking of patient related documents

Tracking changes to the site investigator file (file notes and index)

3. Forms relating to trial procedures

Adverse event report form (for non-serious adverse events)

Breach of GCP report form

Urgent safety measure report form

Training log

Delegation log

Patient document tracking log (use to track patient related documents)

File note (use to document changes to the investigator file)

File note index (keep at front of investigator file to track file notes)