Title/Proposal

Short Title

Study design

Study duration

Study centre

Objectives

Diagnosis

Main inclusion criteria

Study product, dose

regimen
Assesssment schedule

Scales proposed to be used

STUDY TEAM
 1.TITLE

2. TRIAL REGISTRATION
The study is proposed to be registered with the clinical trail registry of the india. Www.ctri.nic.in

3.Protocol version

4.Funding : No governmental funding

5.Roles & responsibilities

INTRODUCTION

6. Background & Rationale

METHODS

7. Research objective & hypothesis

7.1 primary objective

7.2 Secondary objective

7.3 Study hypothesis

8.Trial design
9. Methodology

9.1 Study Settings

9.2 ELIGIBILITY CRITERIA:

9.2.1 Diagnostic Criteria

9.2.2 Inclusion Criteria:

9.2.3 Exclusion criteria

10. INTERVENTIONS

10.1 Selection of medicine

11 OUTCOMES PARAMETERS

11.1 Primary outcome:

11.2 Secondary outcome:

12. STUDY DURATION

13. SAMPLE SIZE

14. RECRUITMENT

15. ASSIGNMENT OF INTERVENTION

16. DATA COLLECTION AND MANAGEMENT

 16. 1 Data collection procedure

17. RECORD KEEPING

17.1 At Study Center

18. STATISTICAL METHODS

19. MONITORING

19.1 Monitoring process

19.2 Specific considerations

20. PREMATURE TERMINATION OF STUDY

21. RECORDING OF ADVERSE EVENTS (AE)

22. ETHICAL CONSIDERATIONS Confidentiality

23. TRAINING

24. PROTOCOL AMENDMENTS

25. COMMUNICATION/ PUBLICATION OF STUDY RESULTS:

References:

List of annexure: