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CPRD/DECIDE
Clinical Practice Research Datalink (CPRD) and Medicines and Health care products
Regulatory Authority (MHRA)
Study:
Will determine the effectiveness of Dapagliflozin compared to Standard of Care for second
line treatment.
Practice Involvement (EMIS/Vision Practices):
Step 1
Interested Practices need to join CPRD using online link
http://www.cprd.com/generalpractitioner/
Send Expression of interest to [email protected]
Step 2
Set up
1. Sign and return Investigator Agreement, protocol signature page, CV and online Site
specific information (using IRAS account)
2. Complete a short eLearning module (GCP and Protocol training) on CPRD study platform
when your site is activated
3. Store and maintain the supplied Site Investigator File
Step 3
Patient Recruitment
During the standard appointment
Patient population: Type 2 Diabetes Mellitus; Uncontrolled on first-line metformin
treatment
1. Identify potential participants (List is provided by CPRD which will be within EMIS WEB)
2. Consent (using online CPRD platform)
3. Randomise(using online CPRD platform)
Reimbursement
1. £200/patient enrolled (Vision), £300 (EMIS)
2. £250 Site set-up and management
3. Additional drug reimbursement per patient per month is provided