About the Trial Protocol Tool
What is a pragmatic trial?
Getting started
A protocol template
What should be in a good protocol?
Summary
Introduction
Background and prior research
Rationale
Overview of RCTs and trial design
Parallel trial
Cluster randomised controlled trial
Multiple arm trials
Factorial clinical trial
Crossover design
Equivalence design
Teaching resources
The research question
Aim
Objectives
Single or multicentre trials
Teaching resources
RCT population
Trial site(s) and population(s)
Inclusion and exclusion criteria
Sources or methods of recruitment
Information for participants
Teaching resources
Allocation of interventions
Methods for randomization & stratification
Methods for concealment of allocation
Teaching resources
The interventions
Description of interventions and intervention delivery
Teaching resources
Outcome assessment
Outcome measures
Timing of outcome assessment
Blinding
Teaching resources
Post-recruitment retention strategies
Participant retention
Safety monitoring and adverse events
Data and safety monitoring
Adverse event reporting requirements
Data collection and management
Data collection
Data management system
Data entry
Quality control
Progress reports
Final report
Sample size
Sample size justification
Compliance and missing data
Analysis strategies
Dummy tables
Statistical analysis
Interim analyses
Ethical aspects of RCTs
Participant consent
Teaching resources
RCT management
Registering the trial
Trial management
Local coordination
Research governance and good clinical practice
Economic evaluation
Economic evaluation
Consumer involvment
Consumer involvement
Reporting, dissemination and notification of results
Publication policy
Disseminating the results
References
Reference list
Useful Documents
Collected documents
Protocol Library
WHO Pre-eclampsia trial
Perinatal care trial
CRASH trial
INIS trial
ISAT trial
Magpie trial
RaPP trial
PRISM trial
WELLINGTON trial
KAT trial
RECORD trial
SYTRUST trial
Teaching Resources
Web Resources
Web resources
Glossary