Regulatory Information, Toolkits & Templates

Regulatory Information

• European Forum for Good Clinical Practice

• European Medicines Agency regulatory information

• MRC Regulatory Support Centre

Toolkits

• NIHR clinical trials toolkit

UCL Innovative Clinical Trials Unit Templates

At the Innovative Clinical Trials Unit (formerly the MRC Clinical Trials Unit at UCL), we have developed several template documents

These documents include a template protocol, statistical analysis plan, and template charters, which help us run our trials.

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