DRUG-FOOD

A QUESTIONNAIRE-BASED SURVEY TO ASSESS THE

LEVEL OF KNOWLEDGE AND AWARENESS ABOUT
DRUG - FOOD INTERACTIONS AMONG THE
MEDICAL STUDENTS.

INFORMED CONSENT FORM

(English)
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INFORMED CONSENT FORM

Subject Name:

Subject ID:

PART 1 – PATIENT INFORMATION SHEET

STUDY TITLE - A Questionnaire based survey to assess the level of knowledge and
awareness about drug-food interactions among the medical students.
Protocol version: Version 1.0

1.1 What is the background and purpose of the study?

• Since you work in the healthcare industry, you are invited to take part in this
drug-food interaction study. An essential component of healthcare is assessing
the public's awareness and understanding of the numerous kinds of medication
interactions. Food drug interactions occur due to interaction between the drug
and food products leading to decreased efficacy of the medication by bringing
about change in pharmacokinetics, pharmacodynamics of the drugs.
• The current study aimed to explore the degree to evaluate the knowledge
attitude regarding the food and drug interactions among the medical
undergraduate students.

1.2 Why are you being asked to participate in the study?

You are being invited to take part in a study. To assess the knowledge of drug-
drug, drug-disease, and drug-disease –food interactions, and it emphasized the
importance of drug-food interactions among the medical undergraduate
students.
• Moreover, this study is designed to identify any correlations among the
undergraduate medical students to access the level of knowledge and awareness
of taking drugs with food.
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1.3 What will happen during the research study?

They were informed about the study and their consent was obtained. The
student’s identities will be hidden. The cross-sectional study comprised a
standardized, self- administered questionnaire.

Filling out the form would take about 5- 10 minutes.

1.4 Are there any benefits to your participation?

You may or may not benefit because of your participation in this study. The
results from this study may benefit others in the future.

1.5 How will your data be kept confidential?

Data will be stored, processed, and compiled manually and electronically by the
investigators. Your identity will not be shared in any reports or publications
resulting from this study.

1.6 What are the costs of taking part in the study?

There are no costs for you if you take part in the study.
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1.7 Do you have to take part in the study?

Taking part in this study is voluntary and entirely up to you. No one will force
you to take part in the study. If you choose to participate, you are required to
sign and date this consent form. You may change your mind and withdraw
without giving any reason, at any time. If you choose to not participate or
withdraw from the study, you will not lose any medical benefits to which you
are entitled and will not affect your future medical care.

1.8 Is it compulsory to take part in the study?

Participation in the study is voluntary, and you can opt out whenever you choose.

PART II - CERTIFICATE OF CONSENT

SUBJECT NAME:

DATE OF BIRTH /AGE:

CONTACT DETAILS:
ADDRESS OF THE SUBJECT:

I confirm that I have read and understood the information

sheet dated for the above study and have [ ]
had the opportunity to ask questions.
I understand that my participation in the study is
voluntary and that I am free to withdraw at any time, [ ]
without giving any reason, and without my medical care
or legal.
rights being affected.
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I understand that others working on the Study, the Ethics
Committee and the regulatory authorities will not need
my permission to look at my health records, both in
respect of the current study and any further research that [ ]
may be conducted in relation to it, even if I withdraw
from the trial. I agree to this access. However, I
understand that my identity will not be revealed in any
information released to third parties or published.

I agree not to restrict the use of any data or results that

arise from this study provided such use is only for the [ ]
scientific purpose(s).

I confirm that the study has been explained to me, and I

have had the opportunity to ask questions and ample [ ]
time to decide whether to participate. I know whom to
contact if I have any further questions.

I agree to take part in the above study. [ ]

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I have read and understand the information in this participant information and
informed consent form. I have had an opportunity to ask questions and all my
questions have been answered to my satisfaction. I voluntarily agree to
participate in this study until I decide otherwise. I do not give up any of my
legal rights by signing this participant information and informed consent form. I
will receive a copy of this signed and dated participant information and
informed consent form.

Signature (or Thumb impression) of the Subject/Legally

acceptable Representative
Date: / /
Signatory's Name:

Signature of the Investigator:

Date: _/ /
Study Investigator's Name: