Regulatory Information

 

Toolkits

MRC Clinical Trials Unit at UCL Templates

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.

Protocol 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:

Document     PDF

Template charters

Data Monitoring Committee (doc, 201KB | pdf, 159KB)

Document     PDF

Trial Steering Committee (doc, 224KB | pdf, 164KB)

Document     PDF

Trial Management Group (doc, 130KB | pdf, 125KB)

Document     PDF