S.No.

Special Criteria in Proposal

Additional Documents to be Submitted

1.

Involves study participants from institutions like schools, orphanages,

special needs institutions etc.

Approval letter from the head of the institution

2.

Involves tribal people (including tribal children)

Approval letter from tribal chief [If study is from a different geographic location other than Coimbatore, a letter from the District Collector should also

be enclosed]

3.

To be executed in a geographic location other than Coimbatore and

its suburbs

Approval letter from the IHEC in the area of study execution

4.

Involves a study group, who do not comprehend English

A translation of the ICF in the local language of the area where the study is

being conducted

5.

Involves any kind of supplementation

Evidence for online registration with

CTRI

6.

Involves any kind of biological sample collection

Acceptance letter from a qualified medical doctor, familiar with the area of research, to act as a member in the study panel (Please ensure that the Registration Number of the medical practitioner is present in the seal or the

letter head)

7.

Any kind of special group as study sample ( e.g. infants,toddlers, very young children, transgenders, mentally compromised individuals (from mild to severe), autistic children, differently- abled individuals, individuals with signs of depression, participants afflicted with sensitive conditions like HIV infection, etc., terminally ill patients, unstable patients, individuals who have suffered second or third degree burns, individuals with multiple medical conditions, etc.)

Acceptance letter from a qualified medical doctor, familiar with the area of research, to act as a member in the study panel (Please ensure that the Registration Number of the medical practitioner is present in the seal or the letter head)