Patient Profile Chart for Active Clinical Trial

What are clinical trials?

A clinical trial is a research study which is conducted on human beings with the goal of
answering specific questions about new therapies, vaccines or diagnostic procedures, as well as
new ways of using known treatments. They aid in determining whether new drugs, diagnostics or
treatments used can be safe as well as effective. Carefully conducted clinical trials are the fastest
and safest way to discover treatments that help people.
What are the goals of carrying out this clinical trial?

The clinical trial you will be carrying out will be a mini Phase IV trial, also known as a Post
Marketing Surveillance Trial. This trial takes place after the medicine has received regulatory
approval (market authorization) with the aim of providing broader efficacy and safety
information about the medication in large number of patients, subpopulations of patients, and to
compare and/or combine it with other available treatments. These studies pose the lowest risk of
detection of any adverse effects. Data from this trial will be incorporated into my thesis paper,
which seeks to optimize the medication for chronic non-communicable diseases in our country.

What are the phases of this Trial?

The Trials will consist mainly of three parts:
1. Identifying and designing a complete patient database/medication chart on between 5-10
individuals who you have regular access to, and collecting information that is requested in the
Table that is provided.
2. Administering to them (orally) a certain natural antidote that will be provided. The antidote
will be something that is a very common food and a commercial product so there will be no
concerns of taking any alien substances that may cause health problems.
3. Monitor your patients almost regularly for as long as the trial commences, taking notes on any
side effects or concerns they may be having, as well as ensuring they remain compliant with their
medication.

And what do you get?

1. Invaluable experience in conducting a clinical study, and being part of one of the first official
BRAC Pharmacy Department Clinical Study Team.
2. Recognition of your work in a certificate which will be signed off by both the honourable
Chairperson of our department Dr. Eva Rahman Kabir, as well as our esteemed Associate
Professor Dr. M. Zulfiquer Hossain.
Members who have successfully complied to Part 1 of the trial automatically become eligible to
receive the certificate.
3. Recognition of your contribution in my thesis paper, which will be published by the end of the
year. This will boost your CV as well as provide a lead for any future clinical studies that will
take place in our institution or even city.
4. Small financial compensation for your time and efforts which will be set after the target
medication, target patient group as well as duration of the trial has been decided.

If you have completely understood and agreed with the terms and conditions above, please fill
out your details below and sign this application off. Submit me a copy of this paper by the 22nd of
August, 2016 (Monday)

Name:
ID:
Department:
University/Institution:
Contact Number:
Email Address:

__________________________
Signature

Patient Profile Chart for Active Clinical Trial

1. This page must be printed individually for each patient
2. The table provided in the next page must be printed individually for each medication.
3. Please fill out all information in BLOCK Letters

Name: __________________________________________________________________

Address (Current): _________________________________________________________

Postal Code: ________

Contact Number: ______________________
Sex: ________________________
Age: ________________
Relationship to the Clinical Researcher: _________________________
Medical History (Any ailments the patient has suffered from before or is currently suffering
from):
__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________
__________________________________________________________________________

Any particular diet the patient is on: _____________________________________________

Patient Vaccination history: ____________________________________________________
___________________________________________________________________________

Medical Information Chart:

Note down any medication the patient is currently taking for any chronic non communicable
diseases (Maximum of 5, Minimum of 3)

Medication Information
1. Name of Disease/s:

__________________________________________________________________

2. Name of Medication: __________________________________________________________________

3. Company Name:

___________________________________________________________________

4. Generic Name:

___________________________________________________________________

5. Dosage Form:

___________________________________________________________________

6. Frequency of dosage: ___________________________________________________________________

7. Any noticeable/detectable side effects of taking the medication:
_____________________________________________________________________________________________
_
_____________________________________________________________________________________________
_
_____________________________________________________________________________________________
_

8. Severity of each side effect (On a scale of 1-10, with 1 being negligible/minimum severity
and 10 being maximum severity)
_____________________________________________________________________________________________
_

_____________________________________________________________________________________________
_