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Writing Research

Protocol
Dr Mirza Shiraz Baig
Associate Professor
Department of Pharmacology
Govt. Medical College, Aurangabad
INSTITUTIONAL ETHICS COMMITTEE
CDCSO Reg : ECR/314/Inst/MH/2013

GOVT. MEDICAL COLLEGE AURANGABAD -431001


Phone : 2402412-17 -EXT.273/274 Fax No.0240 2402418/19 email:iecgmca@gmail.com

INSTRUCTIONS:
1. Download and Print this PDF.
2. Read and fill all the details carefully.
3. Incomplete Submission will not be accepted.
4. Submit the Protocol to the department of
Pharmacology, college campus building, 3rd floor.
5. No protocols will be accepted after the declaration of
last date of submission in the meeting schedule
communications to the departments.
6. The Principal Investigator should be present for
presentation during IEC meeting. No substitute or
other members will be allowed on behalf of Principal
Investigator during meeting and such protocols will
not be considered for discussions.
7. Once approval Given changes will NOT be permitted;
please don’t put your request for this. Any changes
OR amendments will be considered only in Next
meeting whenever scheduled…

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……


Application Form CDCSO Reg : ECR/314/Inst/MH/2013

INSTITUTIONAL ETHICS COMMITTEE


GOVT. MEDICAL COLLEGE AURANGABAD -431001
Phone : 2402412-17 -EXT.273/274 Fax No.0240 2402418/19 email:iecgmca@gmail.com
Office: Member Secretary – Professor & Head Department of Pharmacology, GMC, Aurangabad.

APPLICATION FORM

Tittle of the study:

Name of the Principal Investigator /


Post graduate student ( in block letters
with space in-between)
Mobile No
1.
Telephone Number
Contact details of Department
email address

Details of Sponsors & Contact


Address (if not write NA)

2.
Mobile No
Telephone Number
Email address

Co- Investigator (s) /PG Guide.

3.

Mobile No (PG Guide)


Telephone Number (PG Guide)
Contact details of Department
Email address (PG Guide)

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……


Application Form

Name & Signature of Principal


investigator /PG student.

Name & Signature of Postgraduate


guide.

Name &Signature (s) of co-


investigators with name

4.

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.

5. Place where research


will be carried out…
Ex:
1. GMC, Aurangabad
2. Outside GMCA
…specify with
permission letter

6. 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


Principal Investigator should be prepared to give brief oral presentation during IEC review meeting..

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……


Application Form
Tittle of the study:
________________________________________________________________________________

________________________________________________________________________________

7. 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.

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……


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 t h e r r e l e v a n t 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…..

PLEASE READ ALL DETAILS CAREFULLY:


1. One Binded copy of complete protocol (Protocol+ CRF+ Appendix+ complete references)
2. Seven copies of ONLY protocol synopsis..
Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……
Incomplete Submissions will not be accepted / will be rejected…
Tittle Page

Note: The protocol should be prepared according to the following guidelines


which are as per the standard official format ….. the points below mentioned
should be described accordingly & whichever is not applicable should be
omitted, simultaneously other relevant data required should be elaborated in
the protocol)

Title of the Study


____________________________________________________________
____________________________________________________________
____________________________________________________________
PROTOCOL NO:
VERSION NO:
EFFECTIVE DATE:
SPONSOR:
Name
Address
Phone
Fax
Mobile
INVESTIGATORS:

(Name/Qualification/Designation/office Address)

1) Principal Investigator

2) Co-investigator

3) Co-investigator

TRIAL CENTER:

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……


PROTOCOL Synopsis in brief

Title Full title of protocol


Shortened title, if one is typically used by you or your
Short Title
Center/Dept.
Protocol Number The standard protocol number used to identify this study.
Phase Clinical study phase (e.g. Phase 1, 2, 3 or 4)
Design attributes such as single blind, double blind or open
Methodology label; Randomized, placebo or active placebo control; cross-
over design, etc.
Estimated duration for the main protocol (e.g. from start of
Study Duration
screening to last patient processed and finishing the study)
Single-center or multi-center. If multi-center, note number of
Study Center(s)
projected centers to be involved.
Objectives Brief statement of primary study objectives
Number of Number of subjects projected for the entire study (e.g. not for
Subjects simply one site, rather for entire study, all sites combined)
Diagnosis and Note the main clinical disease state under study and the key
Main Inclusion inclusion criteria (i.e. not the entire list that will appear later in
Criteria the protocol –rather only the key inclusion criteria)
Study Product, Study drug name (generic name, though can also state
Dose, Route, marketed name if name-brand used in the study). Also dose,
Regimen dose route and dose regimen
Duration of Total duration of drug product administration (including any
administration open-label lead-in, if applicable).
Note if there is a standard reference therapy against which the
Reference
study product is being compared, or if the reference is a
therapy
placebo
Statistical A very brief description of the main elements of the statistical
Methodology methodology to be used in the study. (As few lines as possible).

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……


Study flow chart: (prototype)
(Add the other parameters as per the study, similarly no of Visits may be
added)
(Mark  Where ever applicable)

Pre Follow up On the Post-Study


study Visit 1 Visit 2 day after
surgery
Informed consent
Demographics
Medical history
Concurrent
medicines
Physical exam
Vital signs
Investigations
Serum
Hematology
ECG. etc…
Put a footnote if short form is used…

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……


Sponsors Details if any

Company Detail Address


(All contact Details)

Medical Person of Company


(All contact Details)

Trial Coordinator
(All contact Details)

Project Head/Point Person


(All contact Details)

Other Associates 1.
(All contact Details)
2.

3.

4.

5.

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……


Trial Team

Principal Investigator
(All contact Details)

Co-investigator/Post Graduate
Guide 1.
(All contact Details)
2.

3.

Laboratory Details

In Emergency whom to 1.
contact
2.

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……


Table of Contents

(Heading Under which a Clinical trial protocol needs to be drafted)


Sr.No Particulars Page No
1. Introduction (Explain Study Background & Rationale with references)
Study Objectives
2 2.1:Primary
2.2:Secondary
3 Study Design
Study Population
4.1:Source of Study Population
4.2:Sample size
4.3:Informed Consent
4
4.4:Screening Procedures and formats
4.5:Inclusion Criteria(s)
4.6:Exclusion Criteria(s)
4.7:Flow Chart (if any)
Study Procedure
5.1:Enrollment details
5.2:Randomization Schedule
5.3:Baseline Screening Process and recordings
5.4:Details Procedure of Study (Stepwise)
 In case of Drug trials Cover all the details of Product description: Detail
Pharmacology of Drug, Storage procedures and stability considerations
for drug, Route of administration, Drug Shipment, Drug accountability,
Unblinding procedure During Emergencies, Dosing/Regimen Schedule,
Refill of Prescription as required, any other information as needed…)
5
 In case of Surgical Procedure: Explain detail surgical procedures.
 In case of Investigations: Explain all the details of Instrument (s), if Blood
Collection then sample collection procedure, analysis procedures, and
reporting details.
 In case of non-interventional studies: Explain how you are going to
record the parameters under study in detail.
 In case of Retrospective study: explain the procedure in details of
procuring the retrospective data.
5.5:Follow schedule
5.6:withdrawal/discontinuation criteria(s)
Study Parameters Evaluation: Explain the techniques/procedure of
evaluation of your study parameters.
6 6.1:Safety evaluation procedure and formats
6.2:Efficacy evaluation procedure and Formats
6.3:Any other as per the type of study
7 Statistical Analysis details
8 Study Monitoring Procedures

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……


9 Confidentiality of subjects & Data
10 Data Handling and record keeping
11 Agreements if any (sponsors agreement)
12 Quality assurance
13 Privacy of Personal Data
14 Archival of data
15 Publication Plan
Ethical Considerations
16.1: IEC/IRB Approval and submission details
16 16.2:Declaration of Helsinki
16.3:Statement of Compliance
16.4:statement of conflict of Interest
17 Registrations/Permission Letters for agencies concerned (mandatory)
Details of Funding (very important)
18.1:Renumeration to study subjects
18
18.2:Insurance
18.3:any other
Case report form (very imp tool for recording the data, the document
19 having all legalities of the study subject) it should be prepared in such a way
that it should be self-explanatory and should explain your study objective
Appendix
20.1:Appendix: Study Flow chart
20.2:Appendix: Serious event recording procedure and standard formats
20.3:Appendix: Informed Consent form
20 20.4:Appendix: Patient Information Sheet
20.5:Appendix: patient Diary
20.6:Recording scales if any (e.g. Visual analogue scale for pain analysis)
20.7:Undertaking by the Principal Investigator in approved format
20.8:Resume of Principal Investigator
21 References (enclose complete references Xerox)

Note:

Above details needs to be covered in your study protocol submission to IEC-GMCA.


However, it is also made clear that the above details need to be covered depending upon
the type of study: Intervention, non-intervention, observational study, etc. Accordingly
the details which are not required by a particular type of study thus needs to be omitted
in the submissions……

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……


CRF Protocol Number:

ENROLLMENT NUMBER: PATIENT INITIALS:

Title of the Study


____________________________________________________________
____________________________________________________________
____________________________________________________________
PROTOCOL NO:

VERSION NO:

EFFECTIVE DATE:

SPONSOR:

Name

Address

Phone

Fax

Mobile

INVESTIGATORS:

(Name/Qualification/Designation/office Address)

1) Principal Investigator

2) Co-investigator

3) Co-investigator

TRIAL CENTER:

Confidential Page Number

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……


CRF Protocol Number:

ENROLLMENT NUMBER: PATIENT INITIALS:

GENERAL INSTRUCTIONS FOR FILLING CRF

 Fill up the CRF with a ball point black pen


 Any errors should be crossed with a single line so that the original entry
is visible, the new entry should be made on the same sheet, initialed by
authorized person and dated.
 Do not use white fluid for corrections.
 Enter information into the CRF as and when generated at the
appropriate subject visits.
 Transferring data from notes or records at a later date is not advised.
 Write NA for entries not applicable to subject.
 Do not leave any Box / entry empty. Mark dash for empty boxes / entries.
 Boxes (􀀘) are provided for ticking affirmative information; use the tick
mark only.

________________________ ________________
Investigator Signature Date

Confidential Page Number

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……


CRF Protocol Number:

ENROLLMENT NUMBER: PATIENT INITIALS:

DEMOGRAPHICS

Patients initials: _____________

Date of Birth: Age: Sex (M/F):


􀀘/􀀘/􀀘􀀘 (Years)
DD MM YEAR

Height (cm): Weight (kg):

Informed consent form Yes


On __________________
understood and signed
(dd/mm/yyyy)

________________________ ________________
Investigator Signature Date

Confidential Page Number

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……


CRF Protocol Number:

ENROLLMENT NUMBER: PATIENT INITIALS:

INCLUSION CRITERIA

S.No. Criteria Yes No


1.

2.

3.

4.

5.

If the answer to all of the above questions is “YES”, then include the patient

EXCLUSION CRITERIA
S. No Criteria Yes No Not
applicable
1.

2.

3.

4.

5.

If the answer to all of the above questions is “NO”, then include the patient

________________________ ________________
Investigator Signature Date

Confidential Page Number

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……


CRF Protocol Number:

ENROLLMENT NUMBER: PATIENT INITIALS:

MEDICAL HISTORY (if applicable)

S.No. Long term illness Duration Treatment


Completed Under Not
treatment taken

SURGICAL HISTORY (if applicable)

S.No. Major surgical procedure Indication Duration


after surgery

________________________ ________________
Investigator Signature Date

Confidential Page Number

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……


CRF Protocol Number:

ENROLLMENT NUMBER: PATIENT INITIALS:

Depending upon the nu,ber of visits / Follow up the visit schedule


should me made and may include…..

PHYSICAL EXAMINATION (PRE STUDY-SCREENING)

General Appearance & Nutrition


Normal Abnormal Not Comments
Status done

Skin

Head, Neck & Thyroid

Lymph nodes

Eyes

Ear, nose & throat

Respiratory System

Cardiovascular System

Gastrointestinal system (GERD etc.)

CNS

Musculoskeletal System

Others

Are there any abnormal physical findings present? If yes, please make note of it.

________________________ ________________
Investigator Signature Date

Confidential Page Number

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……


CRF Protocol Number:

ENROLLMENT NUMBER: PATIENT INITIALS:

VITALS

Pulse rate _______________/min

Respiratory rate _______________/min

Heart rate _______________/min

Temperature _______________ 0F

Blood Pressure ________________mm of Hg (SBP/DBP)

________________________ ________________
Investigator Signature Date

Confidential Page Number

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……


CRF Protocol Number:

ENROLLMENT NUMBER: PATIENT INITIALS:

LABORATORY DATA (which ever applicable)

Investigation Normal values Value reported Comments


HEMATOLOGY
Hemoglobin
Red Blood Cells
WBC with differential count
Absolute neutrophil Count
Hematocrit
Mean Corpuscular Volume (MCV)
Mean Corpuscular Volume Concentration
(MCVC)
Platelets
SERUM CHEMISTRY
Blood Urea Nitrogen (BUN)
Creatinine
AST (SGOT) µ/l
ALT (SGPT)µ/l
Albumin
Alkaline phosphatase
Total bilirubin
Bicarbonate
LDH
Glucose fasting
Glucose post prandial
Total protein
Sodium
Potassium
Calcium
Chloride
Cholesterol
Serum pregnancy test (in women of
childbearing potential)
Comments on all clinically significant laboratory values outside normal range(s):

________________________ ________________
Investigator Signature Date

Confidential Page Number

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……


CRF Protocol Number:

ENROLLMENT NUMBER: PATIENT INITIALS:

CONCOMITANT MEDICATION (if applicable)


(The presence of underlying conditions or past surgeries can necessitate the use of various
medications like corticosteriods, chemotherapy or anti-infective medications. If present, a
note of the same should be made as follows).

S. NAME OF DRUG ROUTE OF TOTAL INDICATION DURATION OF DRUG


No ADMINISTRATION DAILY THERAPY
DOSE FROM TO

Note:
 Brand name of the medication preferred over generic name.

 Enter only one medication per section. If more than one medication is used for one
indication, list all of them individually in separate sections.

________________________ ________________
Investigator Signature Date

Confidential Page Number

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……


CRF Protocol Number:

ENROLLMENT NUMBER: PATIENT INITIALS:

Electro-Cardio Graph (ECG)(Pre study-Screening)


Date: Time:
(dd/mm/yyyy)

Findings:

Investigator’s comments

________________________ ________________
Investigator Signature Date
Global assessment:
Confidential Page Number

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……


CRF Protocol Number:

ENROLLMENT NUMBER: PATIENT INITIALS:

Efficacy:

Investigator

Excellent Good Poor

Remarks:
___________________________________________________________________

Efficacy:

Patient

Excellent Good Poor

Remarks:
___________________________________________________________________

Tolerability:

Investigator

Excellent Good Poor

Remarks:
__________________________________________________________________

Patient

Excellent Good Poor

Remarks:
___________________________________________________________________

Investigator Signature Date

Confidential Page Number

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……


CRF Protocol Number:

ENROLLMENT NUMBER: PATIENT INITIALS:

STUDY COMPLETION
Study completed Yes No

If yes, Date of Study Completion: ___ ___/ ___ ___/ ___ ___
DD MM YEAR

If No, Date of Withdrawal: ___ ___/ ___ ___/ ___ ___


DD MM YEAR
The Reasons for Withdrawal:

No response

Other illness

Adverse event

Lost to follow Up of Patient

Others

Death

In case of Death (if any)


a) Date of death: _________________________________

b) Cause of death: _______________________________________________

c) Possible causal relationship with the trial: ____________________________

Any Other Comments:


________________________________________________________________________
________________________________________________________________________
________________________________________________________________________

INVESTIGATOR’S STATEMENT:
The data generated and reproduced of above is of authenticate and genuine to my
knowledge.

________________________ ________________
Investigator Signature Date

Confidential Page Number

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……


Appendix-1
Patient Informed Consent Form

Title of the Study:

PATIENT INFORMATION SHEET (version no: date: )


(Give Details) IN MARATHI/HINDI/ENGLISH
Introduction

Purpose of the study

Eligibility to participate

To determine your eligibility, the doctor will also have to conduct physical examination, record the vital
data and conduct few investigations like blood tests, ECG and others (if applicable) as specified by the
study protocol. The doctor will then discuss with you whether you qualify to participate in this study or
not.

Study Procedure

Duration of the study

RISKS

POSSIBLE BENEFITS

ALTERNATIVE TO PARTICIPATION

INDEMNITY

CONFIDENTIALITY
If you agree to participate in this study, the information obtained will be kept confidential and only
Competent authorities like the Independent Ethics Committee, Institutional Review Board, the
Government Health Authorities, the Sponsor and/or its representatives can have direct access to the
Records.

Medical records will be treated as confidential and only that data, which does not identify the patient,
will be shared with the above and may be published.

Protocol No: Confidential Page 1 of 4

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……


Appendix-1
Patient Informed Consent Form
VOLUNTARY PARTICIPATION

 Your participation in this study is entirely voluntary.


 You may refuse to take part in this study
 You may withdraw at any time, without a penalty or loss of benefits of treatment or relationship
with the treating doctor.
 Any new information that might affect your participation will be shared with you.
 If you decide to stop being a part of the study, Dr.____________________________________
or a team member will talk to you regarding making this choice.

QUESTIONS

You are encouraged to ask questions and clear any doubts. If you have any questions about this study or
your rights, please contact
Name: Dr. ____________________________________
Address: ___________________________________________________________________
___________________________________________________________________
Phone No: _____________________________________

SIGNATURES

To be enrolled into this study, you and your legal representative must sign and date the signature page of
the informed consent form.

Protocol No: Confidential Page 2 of 4

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……


Appendix-1
Patient Informed Consent Form

Title of Study:

SIGNATURE PAGE
I confirm that:
1. I have read the Patient Information Sheet and have understood it and carefully
considered it.
2. I have had a chance to ask questions and these have been answered to my satisfaction.
3. My participation in this study is entirely voluntary.
4. I agree to follow all study procedures and provide all information as required by the
medical team treating me.
5. I am free to withdraw at any time from the study should I so desire.
6. I have received a copy of the Patient Information Sheet and Consent Form.
7. All my medical records will be treated as confidential and only that data which does
not identify me will be shared with the competent authorities and may be published.
8. I allow the Sponsor the use of any data or results arising from this study.
9. My present address is ___________________________________________________
_____________________________________________________________________

and I will keep Dr.__________________________________ informed in case there


is a change in my address.

________________________________________
Patient’s Name

________________________________________ _______________
Sign/Left thumb impression of Patient Date

________________________________________
Name of Patient’s Legal Representative

________________________________________ _______________
Sign/Left thumb impression of Patient’s Legal Representative Date

________________________________________ _______________
Name & Sign of Individual obtaining consent Date

________________________________________ _______________
Name & Sign of Impartial Witness Date

________________________________________ _______________
Name & Sign of Investigator (if not signed above) Date

Protocol No: Confidential Page 3 of 4

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……


Appendix-1
Patient Informed Consent Form
PATIENT CONSENT FORM

I exercising my free power of choice hereby give


my consent to be included as a subject in the clinical study of drugs namely
____________________ or __________________________ for treatment of
_______________________ disease.
I understand that I may be treated with this medication for the above condition. I am
suffering from ________________________ disease and have been informed to my satisfaction
by the attending physician the purpose of clinical study, nature of _____________________
treatment and follow up including the laboratory investigation to monitor and safeguard my body
function.
I am also aware of my right to opt out of the study any time during the course of the study
without having to give the reasons for doing so.

Signature of the patient Signature of the attending physician


Date:

रुग्ण संमती पत्र


मी या संम-तीपत्राद्वारे वरील वैद्यकीय संशोधनाच्या
चाचणीमध्ये सहभाग घेण्यास संमती देत आहे. या चाचणीद्वारे _____________________ आणण
______________________ या औषधांचा वापर _______________________________ या आजारामध्ये के ला
जाईल. मला माणहत आहे की मला ___________________________ हा आजार आहे व मला या चाचणीमध्ये
______________________ ककं वा ________________________________ या औषधाचे सेवन करावे लागेल.
मला वरील औषधाच्या चाचणीची उपयोणगता, यात घेतल्या जाणा-या णवणवध तपासण्या, तयांची गंभीरता व यात
होणारी संभणवत हानी या णवषयी समाधानकारक माणहती डॉक्टरांद्वारे ददली गेली आहे. मला ठाउक आहे की या
चाचणीमध्ये सहभागी झाल्यावर मी कु ठल्याही क्षणी यातून बाहेर पडू शकतो.

रुग्णाची स्वाक्षरी उपणस्ित डॉक्टरांची स्वाक्षरी


ददनांक:

मरीज अनुमती पत्र


मैं इस अनुमती पत्रद्वारा उपरणलणित वैद्यदकय प्रयोग/ उपक्रम में शामील हो रहा हुँ। यह
वैद्यदकय प्रयोग ________________________ के इलाज में _______________________ व
__________________________ इन दवाईयों की आवश्यकता साणबत करने के णलए दकया जा रहा है। मैं जानता हुँ की
इस प्रयोग में मुझे ______________________ अिवा ____________________________इन दवाईयों का सेवन
करना पडेगा।
मुझे इस उपक्रम की पूरी जानकारी, इसमे आवश्यक सभी प्रकार की जाुँचे तिा उनकी गंभीरता एवं संभवीत हानी से
अवगत दकया गया है। मैं यह भी जानता हुँ की मैं प्रयोग इस के दौरान दकसी भी वक्त इसमे शामील होने से इन्कार कर
सकता हुँ|

मरीज के हस्ताक्षर उपणस्ित डॉक्टर के हस्ताक्षर

ददनांक:

Protocol No: Confidential Page 4 of 4

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……


To be submitted on letter head (if available)
Fill all the details as below
------------------------------------------------------------------------------------------------------------
UNDERTAKING BY THE INVESTIGATOR
1. Principal Investigator
Full Name:
Address:
Qualifications:
Training/Experience details:
Medical Council Registration Number:
(Attach proofs of Medical council registration/ qualifications/ Training/
experience)
2. Trial site- Hospital/ dispensary/ medical college
Name :
Address:
3. Clinical laboratory facilities
Full Name:
Address:
4. Ethics Committee responsible for continuous study review and approval
Full Name:
Address:
5. Members of the research team- details with name , address, qualifications, role in
the study:
1.

2.

3.

6. Protocol title and study number:

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad…… 1


7. Commitments
a. I have reviewed the clinical protocol and agree that it contains all the
necessary information to conduct the study. I will not begin the study until all
necessary Ethics Committee and regulatory approvals have been obtained.
b. I agree to conduct the study in accordance with the current protocol. I will not
implement any deviation form or changes of the protocol without agreement
by the sponsor and prior review and documented approval/ favorable opinion
from the Ethics Committee of the amendment, except where necessary to
eliminate an immediate hazard(s) to the trial subjects or when the change(s)
involved are only logistical and administrative in nature.
c. I agree to personally conduct and/ or supervise the clinical trial at my site.
d. I agree to inform all subjects, which the drugs are being used for
investigational purposes and I will ensure that the requirements relating to
obtaining informed consent and ethics committee review and approval
specified in the GCP guidelines are met.
e. I agree to report to the Sponsor all adverse experiences that occur in the
course of the investigation(s) in accordance with the regulatory and GCP
Guidelines.
f. I have read and understood the information in the Investigator’s brochure,
including all potential risks and side effects of the drugs.
g. I agree to ensure all associates, colleagues and employees assisting in the
conduct of the study are suitably qualified and experienced and they have
been informed about their obligations in meeting their commitments in the
trial.
h. I agree to maintain adequate and accurate records and to make those records
available for audit/ inspection by the sponsor, Ethics Committee, Licensing
Authority or their authorized representatives, in accordance with regulatory
and GCP provisions. I will fully cooperate with any study related audit
conducted by regulatory officials or authorized representatives of the sponsor.
i. I agree to promptly report to the Ethics Committee all changes in the clinical
trial activities and all unanticipated problems involving risks to human
subjects or others.
j. I agree to inform all unexpected serious events to the sponsor as well as the
Ethics Committee within seven days of their occurrence.
k. I will maintain confidentiality of the identification of all participating study
patients and assure security and confidentiality of study data.
l. I agree to comply with all other requirements, guidelines and statutory
obligations as applicable to clinical investigators participating in clinical trials

8. Signature of the Investigator with date.

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad…… 2


AE/SAE Reporting form

AE/SAE Reporting form


Patient details:
Initials&other relevant
identifier:
(Hospital/OPD record no. etc)
Gender: Weight in Kg: Date of birth Height in cm:
(dd/mm/yyyy)

Suspected drug(s):

Generic name of the drug

Indication(s) for which suspect drug


was prescribed or tested

Dosage form and strength

Daily dose and regimen (specify units ex. mg,


ml, mg/kg)

Route of administration

Starting date & time of day


(dd/mm/yyyy)(am/pm)
Stopping date & time of day (or) duration of
treatment (dd/mm/yyyy)(am/pm)
Details of Adverse event: (Mention in detail about the medical event
and if possible specific diagnosis for that condition)

________________________ ________________
Investigator Signature Date

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……


AE/SAE Reporting form

Expectedness:

Expected: Unexpected:
Intensity: (Investigator discretion/guidelines)

Mild: Moderate: Severe:


Assessment: (Investigator discretion/guidelines)

Serious: Not-serious

Relationship to study medication:

Un related

Un likely

Possibly

Probably

Definitely

Un known

Other attributable causes

Other causes:

Primary underlying disease

Study indication

Concomitant medication

________________________ ________________
Investigator Signature Date

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……


AE/SAE Reporting form

Study participation

Other cause (Specify)

Action taken:

Yield/Out come:

Complete recovery (with out sequelae)

Recovered (with sequelae)

Ongoing

Ongoing at the time of death

________________________ ________________
Investigator Signature Date

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……


AE/SAE Reporting form

Death

Un known

Others (Specify)

Duration:

Start date: (dd/mm/yyyy): Stop date (dd/mm/yyyy):

Details of the Investigator:

Name

Address

Telephone no.

Profession (Speciality)

Signature

________________________ ________________
Investigator Signature Date

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……


CURRICULUM –VITAE

Name :

Photo
Residential Address :

Office Address :
(Phone & Mobile Number)

Educational Qualification:

Present Status :

Clinical Experience:

Other relevant information:

Signature, Stamp & Date

Prepared by Dr M S Baig, Associate Professor & Member IEC-GMC, Aurangabad……