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 :

ProspectiveRetrospective
 Single centerMulticenterMultinational
 No. of centers________________
2.Does the study  involve use of  : Drug/Vaccine DeviceAlternative Medicine
 Any Other 
 If  other,  please specify_________________________
 Not Applicable
 i) Is the test drug/device  marketed   in IndiaYes 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)?YesNo
 If yes, is the   Investigator’s Brochure which contains
 data of pre-clinical studies attached.YesNo
 In Additional Documents  Chapter  On Page no ____
 If IND, is attach DCG(I) permission.YesNo
 In Additional Documents  Chapter  On Page no ____
 iii)  Does the test  drug involve a change  in use, dosage,route of administration?YesNo
 If yes, is copy of DCG(I) permission attached In Additional Documents  Chapter  On Page no ____

3. Clinical Study is   :

Phase IPhase  IIPhase IIIPhase IV
4. Subject Selection :
i)  Number of  subjects at this  centre                               
ii) If multicentric,Total number of subjects________________
iii) If multinationationalTotal number of Subject  In Indian Centres________________
 Total Number of patients in all centres________________
iv)  Vulnerable  subjects:YesNo
(If yes, circle the correct options)
Pregnant women Children ElderlyFetus Illiterate
HandicappedSeriously/terminallyMentally challenged
Economically/socially backwardAny other
If other, please specify___________________________________________________________________________________
v)  Special group   subjects:  Yes  No  (If yes, circle the correct options)
EmployeesStudents Nurses/dependent staffAny other
If  other,  please specify___________________________________________________________________________________
5.Does the study   involve use of
i) fetal tissue or abortusYesNo
ii) organs  or body  fluidsYesNo
iii) recombinant/gene therapyYesNo
If yes, is copy of GEAC permission permission attached
In Additional Documents  Chapter   On Page no ____ 
iv) ionizing  radiation/radioisotopesYesNo
If yes, is copy of BARC permission  permission attachedYesNo
In Additional Documents  Chapter  On Page no ____ 
  v)  Infectious/biohazardous specimensYesNO
vi)Will pre-existing/stored/left  over sample   be used?YesNo
vii)Will samples   be collected for banking/future researchYesNo
                                   

 viii)Will any sample collected from patients    be sent  abroad?

YesNo

If yes, is copy of DGFT approval /permission    attached

YesNo
In Additional Documents  Chapter   On Page no ____ 

  ix)Is    there any collaboration with any foreign lab., clinic or hospital?

YesNo

If yes, is copy of HMSC approval / permission    attached

YesNo
In Additional Documents  Chapter  On Page no ____ 
6. Will any advertising be done for recruitment of  Subjects? YesNo
(Posters, flyers, brochures, etc.)
If yes, is a copy for IEC(HR) review
YesNo
In Additional Documents  Chapter   On Page no ____  
7. Data Monitoring 
i)Is there a separate data & safety monitoring  board (DSMB)?YesNo
i)Is there  a plan for interim analysis of data? YesNo
iii)For how long   will the trial  data be  preserved?            _________years
8. Is there compensation for participation?YesNo
If yesMonetaryIn kind
Specify  amount/type:___________________________________ 
9. Is there any arrangement for compensation for trial  related injury?  YesNo
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
 

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