SOP's, forms and documents

SOP's:

• In- and exclusion criteria DOXA-trial
• Handling of study medication
• ALEA instructions
• Randomization instructions ALEA
• ALEA instructions Pharmacy
• Emergency unblinding

Forms and formats:

• SAE form
• Format notition electronic patient dossier
• Format letter to primary physician

Documents:

• Insurance form 
• Workmap DOXA-trial
• Reporting SAE's and SUSAR's

French documents:

• Protocol de travail DOXA-trial