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Project Summary Format

Project Summary
The Principal Investigator is required to fill the details in the summary in their own handwriting
Please circle appropriate option / provide details where require

Abbreviated Project Title

Project Title

Sponsored Study Not Sponsored Study

Name & Address of Sponsor ( If sponsored )

Estimated Duration of the project
I / we understand that the sanction will be granted for one year only at a time and only on submission of the Trial report along with communication of for extending the duration of the project further as per the estimated Time of the project shall the project be allowed to continue after 1 year.

1. Type of Study :	Prospective	Retrospective
	Single center	Multicenter	Multinational
		No. of centers________________
2.Does the study involve use of :	Drug/Vaccine	Device	Alternative Medicine
	Any Other
	If other, please specify_________________________
	Not Applicable
	i) Is the test drug/device marketed in India	Yes	NO
	Is marketed in other countries:	Yes	NO
	Please Specify_________________
	If not marketed in India, is DCG(I) permission attached .	Yes	No
	In Additional Documents Chapter On Page no ____
	ii) Is the test drug an Invistigational New Drug(IND)?	Yes	No
	If yes, is the Investigator’s Brochure which contains
	data of pre-clinical studies attached.	Yes	No
	In Additional Documents Chapter On Page no ____
	If IND, is attach DCG(I) permission.	Yes	No
	In Additional Documents Chapter On Page no ____
	iii) Does the test drug involve a change in use, dosage,route of administration?	Yes	No
	If yes, is copy of DCG(I) permission attached In Additional Documents Chapter On Page no ____

3. Clinical Study is :	Phase I	Phase II	Phase III	Phase IV
4. Subject Selection :
i) Number of subjects at this centre
ii) If multicentric,	Total number of subjects	________________
iii) If multinationational	Total number of Subject In Indian Centres	________________
	Total Number of patients in all centres	________________
iv) Vulnerable subjects:	Yes	No
(If yes, circle the correct options)
Pregnant women	Children	Elderly	Fetus	Illiterate
Handicapped	Seriously/terminally	Mentally challenged
Economically/socially backward	Any other
If other, please specify___________________________________________________________________________________
v) Special group subjects: Yes	No	(If yes, circle the correct options)
Employees	Students	Nurses/dependent staff	Any other
If other, please specify___________________________________________________________________________________
5.Does the study involve use of
i) fetal tissue or abortus	Yes	No
ii) organs or body fluids	Yes	No
iii) recombinant/gene therapy	Yes	No
If yes, is copy of GEAC permission permission attached
In Additional Documents Chapter On Page no ____
iv) ionizing radiation/radioisotopes	Yes	No
If yes, is copy of BARC permission permission attached	Yes	No
In Additional Documents Chapter On Page no ____
v) Infectious/biohazardous specimens	Yes	NO
vi)Will pre-existing/stored/left over sample be used?	Yes	No
vii)Will samples be collected for banking/future research	Yes	No
viii)Will any sample collected from patients be sent abroad?	Yes	No
If yes, is copy of DGFT approval /permission attached	Yes	No
In Additional Documents Chapter On Page no ____
ix)Is there any collaboration with any foreign lab., clinic or hospital?	Yes	No
If yes, is copy of HMSC approval / permission attached	Yes	No
In Additional Documents Chapter On Page no ____
6. Will any advertising be done for recruitment of Subjects?	Yes	No
(Posters, flyers, brochures, etc.) If yes, is a copy for IEC(HR) review	Yes	No
In Additional Documents Chapter On Page no ____
7. Data Monitoring
i)Is there a separate data & safety monitoring board (DSMB)?	Yes	No
i)Is there a plan for interim analysis of data?	Yes	No
iii)For how long will the trial data be preserved? _________years
8. Is there compensation for participation?	Yes	No
If yes	Monetary	In kind
Specify amount/type:___________________________________
9. Is there any arrangement for compensation for trial related injury?	Yes	No
If yes, is copy of HMSC approval / permission attached
Additional Documents Chapter On Page no ____
We hereby declare the information given above to be true and that we do not have any financial or non-financial conflict of interest. Name of PI /Designation and Department of PI / Signature of PI

Lokmanya Tilak Municipal Medical College

and Lokmanya Tilak Municipal General Hospital

Sion Mumbai

Project Summary Format