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Institutional Ethics Committee Govt. Medical College
Aurangabad (MS)
“IEC-GMCA”
CDSCO Reg. No.ECR/314/Inst/MH/2013
IEC- GMCA REGISTRATION DETAILS
Information as available on website of CDSCO…
Central Drugs Standard Control Organization
Directorate General of Health Services, Ministry of Health and
Family Welfare, Government of India
Sl.No. Name of Ethics Committee(EC) & Address RC No.
288 Institutional Ethics Committee- Govt. Medical College Aurangabad (IEC-GMCA), office of the member secretary & Professor Head Pharmacology, Dept. of Pharmacology, Govt. Medical College , Aurangabad 431001
ECR/314/Inst/MH/2013
Address of the office of the Ethics Committee.
Institutional Ethics Committee-Govt. Medical College,
Aurangabad (IEC-GMCA)
Office:
Member Secretary, Professor Head Pharmacology
Department of Pharmacology,
Govt. Medical College, Aurangabad (MS) 431 001
Contact details:
Phone(Office) 0240 2402412-17 ..Ext 273/274
Fax 2040 2402418…
“Attention to IEC-GMCA: Department of
Pharmacology”
email [email protected]
Dr S H Talib Dr. S M Doifode Chairman IEC-GMCA Member Secretary IEC-GMCA Professor and Head Medicine Professor and Head Pharmacology Department of Medicine, Department of Pharmacology,
MGM Medical College, Aurangabad Govt. Medical College, Aurangabad
CDCSO Reg :ECR/314/Inst/MH/2013
MEMBERS LIST:
Institutional Ethics Committee-Govt. Medical College, Aurangabad
1. Chairperson (Clinician)
Dr.S. H.Talib(MD Medicine)
Professor of Medicine
MGM Medical college,Aurangabad.
Contact Details :07875127786
6. Member (Clinician-Surgeon)*
Dr. A. N. Beedkar (MS Surgery)
Associate Professor Surgery
Govt.Medical College, Aurangabad.
Contact Details:09823076937
2. Member Secretary (Pharmacologist)
Dr.S M Doifode(MD Pharmacology)
Professor & Head Pharmacology
Govt.Medical College,Aurangabad.
Contact Details:09422202625
7. Member (Basic Medical Scientist)
Dr M S Baig (MD Pharmacology)
Associate Professor of Pharmacology
Govt.Medical College,Aurangabad
Contact Details: 09823078631
3. Member (Clinician-Microbiologist)*
Dr A S Damle(MD Microbiology)
Professor & Head of Microbiology
Govt.Medical College, Aurangabad
Contact Details:09822678460
8. Member (Legal Expert):
Mrs B V Paranjape(LL.B)
Assistant Professor
MP Law College, Aurangabad
Contact Details: 9890798823
4. Member (Outside Clinician)
Dr.Sudhir Kulkarni(MD Medicine)
Professor of Nephrology.
MGM Medical College, Aurangabad.
Contact Details:09422713691
9. Member (Lay person):
Shri A P Dhaneshwar(BA)
Deshpandepuram, Shahnoorwade,
Aurangabad.
Contact Details: 7588399512
5. Member (Basic Medical Scientist)
Dr.K U Zine(MD FMT)
Professor & Head of FMT
Govt.Medical College, Aurangabad.
Contact Details:09405234485
Note: * are new members... added in renewal Letter to DCGI
Type of clinical research reviewed by the committee:
o Postgraduate dissertations research
o Clinical Trials
o Epidemiological studies
o Ph.D research works
o Retrospective Analysis studies
o BA, BE studies
o Short term projects
o ICMR Students Projects
How to apply for permission to IEC-GMCA:
1. Collect Soft copy of Application form, Protocol
format, undertaking and other formats, List of
essential documents to be submitted, from the
department of Pharmacology, GMC, and
Aurangabad and submit accordingly.
2. Application in the given format only will be accepted.
3. No Objection from the Department Heads will be
mandatory for interdepartmental studies.
4. For Sponsored studies NOC will be required from
Dean GMC, Aurangabad.
orm
INSTITUTIONAL ETHICSCOMMITTEE GOVT. MEDICALCOLLEGE AURANGABAD-431001
Phone: 2402412-17 -EXT.273/274 FaxNo.0240 2402418/19 email:[email protected]
Office: Member Secretary–Professor &Head Department of Pharmacology, GMC, Aurangabad.
APPLICATIONFORM
Tittle of the study:
1.
Name of the Principal Investigator /
Post graduate student ( in block letters
with space in-between)
Mobile No
Telephone Number
Contact details of Department
email address
2.
Details of Sponsors & Contact
Address (if not write NA)
Mobile No
Telephone Number
Email address
3.
Co- Investigator (s) /PG Guide.
Mobile No (PG Guide)
Telephone Number (PG Guide)
Contact details of Department
Email address (PG Guide)
CDCSO Reg :ECR/314/Inst/MH/2013
Application Form
Office use only
1. Received Application on ___________________
2. All the documents attached or not…..Yes/No
3. IEC Fees Amount (Rs/-) :__________________
4.
Name & Signature of Principal
investigator /PG student.
Name & Signature of Postgraduate
guide.
Name &Signature (s) of co-
investigators with name
Name & Signature of Head of the
department of PI/PG student
Name (s) & Signature (s) of other
Head of the department (s) in
collaborative studies.
Place where research will
be carried out…
Ex:
1. GMC, Aurangabad
2. Outside GMCA
…specify with
permission letter
Details of Financial
aspects/who is responsible
for expenses of the
study..if required attach
details as separate
ANNEXURE..
DECLARATION:
I declare that I shall follow National and International guidelines of Good Clinical Practice (GCP) in
conducting the above clinical research project. I fully owe responsibility of patient care. I am also made
aware by the fact that no changes will be done in the protocol once approved by IEC.
Signature of Principal Investigator
PrincipalInvestigatorshouldbepreparedtogivebrieforalpresentationduring IEC review meeting
Application Form
Tittle of the study:
___________________________________________________________________________
___________________________________________________________________________
The study protocol submissions should include all documents as per SOP:- The following documents were submitted by me: (Tick out the submitted one)
1) Clear and explanatory research tittle, details of background of the research, study
objectives, study design, section criteria’s, study population, sample size,
interventional product details in all perspective, informed consent in vernacular
languages as applicable, procedures that will be followed, investigations, procedures
of data recording, any tech information, Data and safety monitoring procedures as
applicable.
2) For all sponsored studies conducted at Govt. Medical College, Aurangabad, Govt.
Cancer Hospital Aurangabad & Paithan Rural Hospital… It will be mandatory for
Principal Investigator to submit the NO OBJECTION certificate from the Head of
the department & Dean Govt. Medical College, Aurangabad. Without NOC
proposals will not be accepted.
3) All Details of Funding agency / Sponsors….. and fund allocation / utilization/patient
remuneration,/ Signed Indemnity Agreement./Investigator's agreement with the
Sponsors, Proposed compensation and reimbursement of incidental expenses.
Undertaking in this regard of PI & Sponsors will be compulsory.
4) CTRI Registration as Applicable.
5) Permission letters from licensing authorities (DCGI & others)
6) Precise description of methodology of the proposed research, including intended
dosages of drugs, planned duration of treatment and details of invasive procedures
if any.
7) A description of plans to withdraw or withhold standard therapies in the course of
research.
8) Procedure for seeking and obtaining informed consent with sample of patient
information sheet and informed consent forms in English and vernacular
languages.( as specified in the Appendix V of Drugs and cosmetics act 1945).
9) The detail plans for statistical analysis of the study
10) Statement of privacy & confidentiality of personal data
11) Investigators brochure
12) Undertaking by the investigator…. Appendix VII of schedule Y
13) Recent curriculum vitae of the Investigators indicating qualification and
experience
14) Safety of proposed intervention and any drug or vaccine to be tested, including
results of relevant laboratory and animal research.
Application Form
15) For research carrying more than minimal risk, an account of plans to provide
medical therapy for such risk or injury or toxicity due to over dosage should
be included.
16) SAE reporting format as applicable for all interventional studies… as specified in the
Appendix XI of Drugs and cosmetics act 1945/Pharmacovigilance guidelines.
17) All Details of Funding agency/Sponsors and fund allocation/utilization/patient
remuneration/signed indemnity/investigators agreement with sponsors, etc. for the
proposed work. Proposed compensation and reimbursement of incidental expenses.
Undertaking in this regard of PI & Sponsors will be compulsory.
18) Storage and maintenance of all data collected during the trial.
19) Plans for publication of results – positive or negative – while maintaining the
privacy and confidentiality of the study participants.
20) A statement on probable ethics issues and steps taken to tackle the same
21) All o ther r e levant documents related to the study protocol including
regulatory clearances.
22) Agreement to comply with national and international GCP protocols f o r clinical
trials.
23) Detail case record form covering all details of observation to be recorded.
24) A statement stating that NO other data/investigations/interventions will be done or
recorded in the study participants other than approved by the IEC.
25) For international collaborative study details about foreign collaborators and
documents for review of Health Ministry's Screening Committee(HMSC) or
appropriate Committees under other agencies/authority like Drug Controller General
of India (DCGI)
26) For exchange of biological material in international collaborative study a MoU/
Material Transfer Agreement between the collaborating partners.
27) A statement on conflict-of-interest (COI), if any
28) Any other relevant information is to be documented.
29) Mandatory that all Protocols submitted should have attached photo copies of the
references quoted in the study. Without references the protocol will not be
considered for review procedure…
Name & Signature of Principal Investigator
Date:
All submitted Documents will be checked before accepting the Protocol by the
Nominated member of IEC….. Incomplete Submissions will not be accepted.
