Date: <dd/mm/yyyy> / Clinical Research Centre
Template for Clinical Trial Protocol / Page 1 of 3
TP-IIR-1-03-01
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May not be used, divulged, published or otherwise disclosed without the consent of
The Director, Clinical Research Centre
Template for Clinical Trial Protocol
CONFIDENTIALProtocol number.:Insert number / Page <#> of <#>
StudyTitle:Insert title
Clinicalstudyprotocolnumber/version:Insert number
Development phase:Insert phase
Studyinitiation date:dd/mm/yyyy
Studycompletiondate: dd/mm/yyyy
Date ofprotocol: dd/mm/yyyy
Amendmentnumber(s)anddate: Insert number anddd/mm/yyyy
Author(s): Insert name
Author’sandReviewer’ssignatureanddate:
Protocol Author / Reviewed and approved bySignature:Sign here / Signature:Sign here
Date:dd/mm/yyyy / Date:dd/mm/yyyy
Thisprotocolincorporates thefollowingamendment(s):
Amendment No. / Dateof Amendment / Initialsofcoordinator
ConfidentialityStatement
Maynotbeused,divulged,publishedor otherwise disclosed without the written consent of Insert PI’s name or sponsor.
Version No: 1.0Date: <dd/mm/yyyy> / Clinical Research Centre
Template for Clinical Trial Protocol / Page 1 of 3
TP-IIR-1-03-01
CONFIDENTIAL
Protocol number.:Insert number / Page <#> of <#>
1.STUDY TITLE
2.SYNOPSIS
3. TABLE OFCONTENTS
#
/ /Page #
1.
/STUDY TITLE
/2.
/SYNOPSIS
/3.
/TABLE OFCONTENTS
/4.
/LIST OF ABBREVIATIONS
/5.
/GLOSSARY OF TERMS
// ETHICS ®ULATORYCONSIDERATIONS /
/ INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE /
/ BACKGROUND AND RATIONALE /
/ OBJECTIVES /
/ STUDYDESIGN /
/ STUDY POPULATION AND SUBJECTS RECRUITMENT /
/ TREATMENT AND STUDYPROCEDURE /
/ EFFICACY, SAFETY AND OTHER ASSESSMENTS (for trial)
STUDY VARIABLES and MEASUREMENT (for non-trial) /
/ STUDYCONDUCT /
/ STUDY QUALITY ASSURANCE AND DATA MANAGEMENT /
/ STATISTICAL METHODS /
/ ADMINISTRATIVE MATTERS /
/ INVESTIGATOR’S AND SPONSOR’S SIGNATURE /
/ REFERENCES /
/ APPENDIX /
4. LIST OF ABBREVIATIONS
Abbreviation / <Complete text>Abbreviation / <Complete text>
5. GLOSSARY OF TERMS
Term / Definition6. ETHICS ®ULATORYCONSIDERATIONS
7. INVESTIGATORS AND STUDY ADMINISTRATIVE STRUCTURE
8. BACKGROUND AND RATIONALE
CONFIDENTIALProtocol number.:Insert number / Page <#> of <#>
9. OBJECTIVES
10. STUDYDESIGN
11. STUDY POPULATION AND SUBJECTS RECRUITMENT
12. TREATMENT AND STUDYPROCEDURE
13. EFFICACY, SAFETY AND OTHER ASSESSMENTS (for trial)
STUDY VARIABLES and MEASUREMENT (for non-trial)
14.STUDYCONDUCT
15. STUDY QUALITY ASSURANCE AND DATA MANAGEMENT
16. STATISTICAL METHODS
17. ADMINISTRATIVE MATTERS
18. INVESTIGATOR’S AND SPONSOR’S SIGNATURE
19. REFERENCES
20. APPENDIX