Appendix 3(b)
RESEARCH  ETHICS  COMMITTEE - Final Report Form 

FINAL REPORT  -  TO BE COMPLETED AND SUBMITTED TO THE RESEARCH ETHICS COMMITTEE AFTER FINAL ASSESSMENT OF DATA

REC Registration No: 

Title of project:

1.	Name of Principal Investigator :.........................................................................

2.	Institution/Address : ...........................................................................................

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3.	Date of REC approval : .....................................................................................

4.	Date study started : ...........................................................................................

5.	Date study completed :.......................................................................................

6.	Date assessment of data completed..................................................................

7.	Reason(s) for study not starting : ……………………………………………………
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8.	Reason(s) for study not being completed :   .....................................................................

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Proposed aims of study :   ..........................................................................................

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9.	No. of subjects/patients recruited into study :  

	Proposed............................................

	Actual  .....................................................

10.	No. of subjects/patients completing study :     

Proposed .................................................
                                                                       
Actual  .....................................................

11.	No. of withdrawals because of:    

i)  lack of efficacy :  ......................................................

ii)  adverse events  :  .....................................................

iii)  self-withdrawal :  ....................................................

iv)  non-compliance :  ....................................................

12.	No. of adverse events :  ................No. which were treatment-related : ………

	No. of deaths :  ..............................No. which were treatment-related : ….…..

13.	Results - please include details of outcomes and conclusions (attach a separate page if necessary)

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14.	How the findings have been disseminated 

i)  used for licensing/regulatory purposes			Yes		No

ii)  presentations - please give details				Yes		No

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iii)	publications  (please give details below)
planned –	(send copies when available)		Yes		No
In press – (send copies when available)		Yes		No
published – (please send copies)			Yes		No
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Name of Principal Investigator ………………………………………………………….

Signature of Principal Investigator:................................Date of Report..................