Clinical Trial of aNew Medicine({name of investigationalproduct})- What’s a clinical trial? -Pay attention!

Name of your doctor:

Name of your clinical research coordinator:

A “clinical research coordinator” issomeone who tells you about the medicine

that’s going to be tested and helps you withyour medical examinations. Ask yourclinical research coordinator if you have anyquestions about this trial!

Name of Hospital:
Informed Assent Form B
Protocol Number:
Version:Date:

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わかったらなぞろう

Many kinds of medicine (drugs) are used to treat different types of disease.
But before a chemical (called a “drug candidate”) can be used as a medicine,it needs to be tested for safety.
Researchers do tests to see how well a drugcandidate works in a laboratory, often by using
animals like mice.

If a drug candidate seems to work well, both
healthy and sick people (patients) are asked

to volunteer to take the drug candidate to see

the good and bad effects it may have in humans.

This test of the drug candidate is called a Clinical Trial.
When we do a clinical trial at a hospital, we have strict rules
to protect the people taking part. We check if the medical
staff are following the rules. We also make sure that thishospital is the right place to do the medical trial.

After a clinical trial, we send the results to theGovernment

government, where experts check them closely.

If the experts think that the results are good, the candidate

drug becomes a “medicine” which can be used safely to help
many patients.

Please listen carefully to our explanation about this clinical trial of the drugcandidate called {name of an investigational product} and think carefully1Name of Hospital:
Informed Assent Form B
Protocol Number:
Version:Date:

whether you want to take part. Please ask us any questions you have at anytime.

2
わかったらなぞろうThe drug candidate in this trial is called {name of investigational product}
and was made to treat {name of disease}. We’re doing this trial to see how
well {name of investigational product} can help patients like you who have{name of disease}. We’ll also be checking to see whether it can have any badeffects on your health.
Drug candidates like {name of investigational product} that are tested inclinical trials are sometimes called “investigational products”.

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わかったらなぞろう

Number of volunteers
20 patients with {disease name} between 8 to 15 years old will take partin this clinical trial.

Duration
The clinical trial will last 6 weeks.

2Name of Hospital:
Informed Assent Form B
Protocol Number:
Version:Date:

How does a clinical trial work?
You will first get medical examinations so that we can tell the difference before and after using the investigationalproduct.
Exams-StartHeightWeight○○Blood PressurePulse○

Examination

Blood and Urine
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Name of Hospital:
Informed Assent Form B
Protocol Number:
Version:
Date:

Exams

Take the investigational
product (IP)-Start4thweek

8thweek

12thweek

16thweek

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Name of Hospital:
Informed Assent Form B
Protocol Number:
Version:Date:

Example Breathing Function Test
This test checks how well you can breathe.
A tube will be placed in your mouth, and you’ll be asked to breathe
following the nurse’s directions.
Please tell us if it’s difficult for you to breathe or you feel sick so thatyou can take a break.

 Investigational product (IP) in your blood
Once you take the IP, it gets into your blood and circulates throughyour body. Using a blood test, we measure how much of the IP stays
in your blood and how well it works. We will take a sample of yourblood {number} times after you start taking the IP at predetermined
times and dates. On some days, we may ask you to visit the hospital
without taking the IP. In this case, we may take a blood sample onceor more than once on the same day. If we decide to take multiple
blood samples on the same day, we may do so either by (1) Using anormal injection needle or (2) inserting a soft tube into your vein. You
may have some pain or feel a little sick during a blood test.

What to do at home
・ Take the IP according to the schedule you are given.
・ Keep a medical diary {name of diary} with your family.

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Name of Hospital:
Informed Assent Form B
Protocol Number:
Version:Date:

Directions for taking the IP
Please take {name of an investigational product} after each meal, threetimes a day.
Insert a photo ofinvestigational productYou will help test the IP in one of three ways.
A. You will be given lots of {name of investigational product};
B. You will be given a small amount of {name of investigational product};OR
C. You will be taking something that looks like {name of investigationalproduct} but doesn’t contain the product at all, called a “placebo”(pluh-SEE-bo).
Looks the same
appearance

Differentcomponents

ALarge amount of theinvestigational product

B

Small amount of theinvestigational productCNo investigational productat all! (Placebo)

6Name of Hospital:
Informed Assent Form B
Protocol Number:
Version:Date:

If you get the placebo (tablet C), your condition will not change or mayeven become worse because it doesn’t do anything.
Which one of the three ways you get to take the IP will be decided
randomly (by chance). Not even the researchers will know!
Whatever the case, we’ll look after you carefully.
If you feel sick or feel uncomfortable, please tell your family or theresearchers right away. You can quit the clinical trial anytime when you
want to.
What is a “placebo”?
A placebo looks just like {name of investigational product}but doesn’t contain it at all! However, some people feelbetter when they take the placebo because they believe itworks. We use the placebo to compare it with {name ofinvestigational product} so that we get a better idea of how
the IP is working and to check if there are any bad effects
on your health.

7Name of Hospital:
Informed Assent Form B
Protocol Number:
Version:Date:(Example: Dose titration study)

In case a Forced titration
First, you’ll be asked to take small amounts of the investigational
product, then bigger amounts every three days while we check to makesure that everything is OK with your health. This is important to judge
what amount is best for patients the same age and weight as you.

In case a Dose titration
First, you’ll be asked to take small amounts of the investigational
product, then bigger amounts gradually until we can see an effect while
we check to make sure that everything is OK with your health.
This is important to judge what amount is best for patients the sameage and weight as you.
Every 3 days

1st day

Every 3 days

4th dayDose

8

7th day…

Name of Hospital:
Informed Assent Form B
Protocol Number:
Version:
Date:

Dose

The number of times you take itis the same but the amount ineach tablet increases.

1 day
st4 dayth7 dayth9Days

Name of Hospital:
Informed Assent Form B
Protocol Number:
Version:Date:

4

わかったらなぞろう

Each candidate drug has pros and cons. Here are the pros and cons of{name of an investigational product} that we know about so far.

< Pros >Some patients got better but some did not.
Researchers haven’t finished studying {name of an investigationalproduct} yet.
Its effectiveness is different for each person.

< Cons >You may have one or more of the following.
 1 out of 3 patients may feel itchy or get hives.
 1 out of 10 patients may feel ill.
 1 out of 100 patients may get sweaty.
 A very few patients may have trouble breathing.
You may also get other symptoms, but we’ll look after you carefully.
Please tell your family or us if you feel sick or uncomfortable.
Everything you can tell us about how you feel will be very helpful.
We will give you a treatment to feel better if needed.

10Name of Hospital:
Informed Assent Form B
Protocol Number:
Version:Date:

5わかったらなぞろう

1) See your doctor when you’re supposed toYour doctor will examine you often to check the effectiveness of theinvestigational product and make sure that your health is OK.
2) Ask your family before you take any other medicine
Some medicines can’t be taken during the clinical trial.
If you feel sick, before you take another medicine be sure to ask yourfamily if it’s allowed. And please write down (or ask your parents to write
down) the name of the medicine and date you took it in your medicaldiary.
3) Bring your “clinical trial card” whenever you go to anotherhospital or pharmacy

If you go to another hospital, please show your “clinical trial card” to thedoctors there and tell them that you are taking part in a clinical trial andare not allowed to take certain kinds of medicine.
4) Keep a diary during your clinical trial
Please use a diary with your family to write down each time you take theinvestigational product and how you feel. Please bring the diary with you
whenever you visit the hospital and show it to the doctors.
5) Bring all the investigational product you have to the hospital

11Name of Hospital:
Informed Assent Form B
Protocol Number:
Version:Date:

Please don’t throw away any leftover investigational product, including
the empty cases and bags. Give them to your parents and bring all of it
to the hospital.
6) Our request to young people growing up● For girl

Body and mind, you are on your way to becoming a grown-up. If you
are a girl, you may start having your period, which happens atdifferent times to different girls and is a normal part of becoming anadult.
We cannot say how the IP will affect the part of your body wherebabies grow.
If you have already begun having your period, please make sure notto get pregnant during the clinical trial. If you become pregnant,please tell your family or the researchers right away so that we canmake sure that you and your baby are OK.
● For boys

Body and mind, you are on your way to becoming a grown-up. If you
are mature enough, you may already have sperm. When your body
starts growing sperm is different for different boys and is a normalpart of becoming an adult.
We cannot say if the investigational product will affect the part of yourbody where your sperm is made. If you are physically mature enoughto have sperm, please make sure that you don’t get your girlfriend

12Name of Hospital:
Informed Assent Form B
Protocol Number:
Version:Date:

pregnant. If your girlfriend becomes pregnant, please tell your familyor the researchers right away.

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わかったらなぞろう

You can quit the clinical trial in the following cases.
1) You and your family decide to stop.
2) The doctors decide you should not continue because somethingis wrong with your health or the investigational product is notworking for you.

3) The drug company that makes the investigational product has
decided to stop the trial.

4) The hospital has decided to stop the trial (each hospital can
decide to do a clinical trial or not).

7
わかったら
なぞろう

After the trial, we will send the results to the government, but your name,address, and other information about you will not leave the hospital.

Personal information is information about
you like your name, address, phone
number, and so on.

13Name of Hospital:
Informed Assent Form B
Protocol Number:
Version:Date:

8わかったらなぞろう

Please think carefully if you want to take part in this clinical trial or not.
Your decision is the most important thing. Of course, you can ask theadvice of your family and the researchers. If you decide not to take part,
we will give you another treatment that’s already been approved foruse. Please ask the researchers for details.
You can quit the trial at any time after discussing your feelings with yourfamily and us.
Whenever we find any new information about the investigational
product during the trial, we’ll let you know right away. Based on thisnew information, you can decide whether or not to continue.
Please don’t hesitate to ask us anything at all!

9
わかったらなぞろう

Hospital(Example) ○○Hospital

Contact to(Example) Clinical trials division

Phone number14

Name of Hospital:
Informed Assent Form B
Protocol Number:
Version:Date:

Hospital copy●●●

Letter of Assent ●●●I have learned everything I want to know about {name of an investigational
product} and agree to take part in this clinical trial.
Date:

Year/

Month/

Date

Name:

DoctorExplanation date:

Year/

Month/

Date

Name:

Clinical Research CoordinatorExplanation date:

/

Name:

YearMonth/

DateName of Hospital:
Informed Assent Form B
Protocol Number:
Version:Date:Copy (clinical trial)●●●

Letter of Assent ●●●I have learned everything I want to know about {name of an investigational
product} and agree to take part in this clinical trial.
Date:

Year/

Month/

Date

Name:

Doctor

Explanation date:

Year/

Month/

Date

Name:

Clinical Research CoordinatorExplanation date:

/

Name:

YearMonth/

DateName of Hospital:
Informed Assent Form B
Protocol Number:
Version:
Date:

Patient copy●●●

Letter of Assent ●●●I have learned everything I want to know about {name of an investigationalproduct} and agree to take part in this clinical trial.
Date:

Year/

Month/

Date

Name:

Doctor



Explanation date:

Year/

Month/

Date

Name:

Clinical Research CoordinatorExplanation date:

/

Name:

YearMonth/

Date