A template for the protocol of a randomised controlled trial

Summary

Introduction
Background and prior research rationale
Rationale

Overview of  the trial
Design
[Parallel trial, Cluster randomised controlled trial, Multiple arm trial, Factorial clinical trial, Crossover design, Equivalence design]

The research question
Aim
Objectives
[Is the trial single or multicentre?]

Trial population
Trial site(s) and population(s)
Inclusion and exclusion criteria
Sources or methods of recruitment
Information for participants

Allocation of interventions
Methods for randomisation and stratification
Methods for concealment of allocation

The interventions
Description of intervention and intervention delivery

Outcome assessment 
Outcome measures
Timing of outcome assessment
Blinding

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 reports

Sample size
Sample size justification
Compliance and missing data

Analysis strategies
Dummy tables
Statistical analysis
Interim analyses

Ethical aspects
Participant consent

Trial management
Registering the trial
Trial management
Local coordination
Research governance and good clinical practice

Economic evaluation

Consumer involvement

Reporting, Dissemination and Notification of results
Publication policy
Disseminating the results

References