Form

Step 1

Personal info

Category Faculty Student (UG/PG) Research Scholars (PhD)

Name of the College

Department

Emp No or Student Roll No

Investigator Name:

Email Address

Phone Number

Designation

Title of the study

Submission New Resubmission

Proposal Id of the earlier submission

UG/PG

Course

Guide ID

Guide Name

Guide Desgination

Guide Department

Step 2

Type of study Interventional Non Interventional

Type of review requested Regular Expedited

Please select the reason(s) for Expedited review

Involves no more than minimal risk to study participants

Involves data analysis - clinical data form MRD or lab data

Involves analysis of non identifiable / left over / to be discarded tissues/samples

Minor amendments

Step 3

Title of study -

Introduction/Background/Rationale for the study (approx. 250 words):

(Min 500 Max 2000 Characters)

Study Objectives (approx. 50 words):

(Min 100 Max 1200 Characters)

Study design (approx. 25 words):

(Min 10 Max 350 Characters)

Number of subjects/sample size: Applicable Not Applicable

(Min 10 Max 200 Characters)

Step 4

Study Methodology or procedure (approx. 500 words):

(Min 1000 Max 10000 Characters)

Study Outcomes or end points (approx. 30 words) : Applicable Not Applicable

(Min 50 Max 2000 Characters)

Ethical Consideration (approx. 50 words):

(Min 100 Max 800 Characters)

Reference

1.

2.

3

4.

Step 5

Does this study involve obtaining informed consent from the participants ? Yes No

Section II

Participant Information Sheet

Note:

This section shall have the following information, whichever is applicable

Describe nature of the study and study procedures.
Details of the interventions.
Details of the adverse events of the interventions.
Compensation for study participation including travel and incidental expenses.
Discomforts to the participants due to their participation in the study.
Blood loss due to participation in the study to the study participants.
Management of adverse events

Information to the study participant / study subject (Approx. 500 words) :

Title of the Study :

(Min 2000 Max 7500 Characters)

Consent form

Consent form (Approx. 125 to 500 words) : [ The PI can modify the consent form according to the study ]

Title of the Study :

(Min 400 Max 1500 Characters)

Name of the Participant

Signature/thumb impression of the participant

Date

Name of the Witness (If applicable)

Signature

Date

Name of the Investigator

Signature

Date

Translated participant information sheet and informed consent form
(Upload only PDF File - Max file size: 5MB)

Step 6

Annexures

Case record form/ Study Proforma
(Upload only PDF File - Max file size: 5MB)

Questionnaire
(Upload only PDF File - Max file size: 5MB)

Other relevant documents (if any)
(Upload only PDF File - Max file size: 5MB)

Chettinad Academy of Research & Education

Institutional Human Ethics Committee

( CARE - IHEC )

IHEC Proposal Submission

Step 1

Personal info

Step 2

Step 3

Title of study -

Step 4

Step 5

Section II

Participant Information Sheet

Note:

Consent form

Step 6

Annexures