Regulatory Information, Toolkits & Templates
Regulatory Information
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European Forum for Good Clinical Practice
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European Medicines Agency regulatory information
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MRC Regulatory Support Centre
Toolkits
MRC Clinical Trials Unit at UCL Templates
At the MRC Clinical Trials Unit at UCL have developed several template documents
These documents include a template protocol, statistical analysis plan, and template charters, which help us run our trials. If you would like to download any of the template charters or Statistical Analysis Plan Template, please enter your details in the pop-up window that will appear when you click the link. You will then be able to download the relevant file(s). We will use this information to help us monitor the uptake of this template.
Statistical analysis plan template
A guidance document on creating a Statistical Analysis Plans (SAP) for Independent Data Monitoring Committee (IDMC) Reports and Final Statistical Reports.
View template:
Template charters
Data Monitoring Committee (doc, 201KB | pdf, 159KB)
Trial Steering Committee (doc, 224KB | pdf, 164KB)
Trial Management Group (doc, 130KB | pdf, 125KB)