SEARCH

SEARCH BY CITATION

1. Trial title

Acronym

International Standardised Randomised Controlled Trial Number (ISRCTN)

Trial sponsor

Principal investigator

Main co-investigators

2. Summary

3. Background

Including results of systematic review

4. Hypothesis

State the main trial hypothesis

5. Interventions

Treatment group

Control group

6. Randomisation procedure

7. Outcome measures

Primary end point

Secondary end points

8. Number of patients required

Sample size

Justification for sample size (power calculation)

9. Eligibility criteria

Inclusion criteria

Exclusion criteria

10. Trial process

Recruitment

Consent

Registration/randomisation

Treatment

Follow up

Expected start date

Expected completion date

11. Data collection

• Pre-randomisation data

What?

When collected?

By whom?

How?

• Post-randomisation data (e.g. compliance data)

What?

When collected?

By whom?

How?

• Outcome data

What?

When collected?

By whom?

How?

Details of blinding if applicable.

12. Interventions

Describe in detail

Measures to ensure compliance

13. Statistical analysis plan

Primary analysis

Exploratory analyses

Predefined subgroups

14. Publication policy

15. Trial Steering Committee

Membership

16. Data Monitoring and Ethics Committee

Membership

17. Centres

Names of participating centres

Local co-ordinators

18. Funding

19. References

20. Forms

Attach copies of all forms to be used in the trial. These should include Patient Information Sheet, Consent form, GP information sheet, trial entry data form and outcome/follow up forms.