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 A
Protocol Number:
Version:Date:

1
わかったらなぞろうA lot researchers spend a lot of time studying a newmedicine before people are able to use it.

Sick people (patients) help test new medicines to see
how they work in a “clinical trial.”
All the researchers make sure nothing bad happens tothe sick people in a trial.
The new medicine that’s being tested
is called an “investigational product (IP).”

Like at other hospitals, the doctors at thishospital plan and do clinical trials afterdiscussion.

After a clinical trial proves that a newmedicine is safe and works well, it can beused to help many patients.

1Name of Hospital:
Informed Assent Form AProtocol Number:
Version:Date:

2

The Investigational Product (IP)わかったらなぞろうDo you have {disease name} or cough often or find it hard to breathe?

Difficulty breathing

Difficulty breathing

The IP in this trial, called {name of investigational product}, was made to curethese symptoms.
First, let’s think about a few important things to decide if you should orshould not take part in this clinical trial of {name of investigational product}.
Please ask any questions you have at any time.

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

3

What Happens in a Clinical Trial?
わかったらなぞろう

How many people get to take part in this clinical trial?
20 patients with {disease name} who are between 5 and 9 years old will takepart.

What will you be checking during the clinical trial?
We’ll be checking to see how {name of investigational product} works andwhether anything bad happens to the patients’ health as a result of taking
the product.

What kind of IP will I be taking?
You will be taking an IP called {name of medicine} during the trial bybreathing it in twice a day, once in the morning and once in the afternoon.

Insert a photo ofinvestigational product3

Name of Hospital:
Informed Assent Form A
Protocol Number:
Version:Date:(Example: Parallel-group comparison study)
You’ll be asked to take either:A. (IP) orB. (IP)Both IP’s may help cure your sickness and make you feel better.
Insert a photo of investigational

Insert a photo of investigational

product Aproduct B(Example: Dose titration study)
In case a Forced titration
First, you’ll take a small amount of the IP.
Then, the amount will be increased every () days while researchers keep

checking to see that your health is OK.

In case a Dose titration
First, you’ll take a small amount of the IP.
Then, the amount will be increased every (checking to see that your health is OK.

4) days while researchers keep

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

How Does This Trial Work?
You will have medical examinations at the hospital as scheduled,then receive the IP.

HeightWeight

Take a blood and urine test

Blood pressure and pulse

Get a check-up

Receive the IP

Breathe in and out as strongly as
you can following instructions.
Please tell us if it’s hard for you toBreath test

breathe or if you feel sick.

Other researchers may use your test information but
we won’t tell anyone your name or other personal
information.

5Name of Hospital:
Informed Assent Form A
Protocol Number:
Version:
Date:

What to Do at HomeMorning

Please check your peak flow soon after you wake up andwrite it down in your medical diary.
Then inhale (breathe in) the IP.
Don’t forget to wash out your mouth after inhaling theIP！

Evening

Check your peak flow just before sleeping and write it
down in your medical diary.
Then inhale the IP.
Again, don’t forget to wash out your mouth after inhalingthe IP！

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

Promises for You to Keep during the Clinical Trial
1. Please don’t eat {name of forbidden food etc.} when you take the IP
because eating may stop it from working properly.

2. Please follow the directions you’re given when taking the IP.

3. Make sure to visit your doctor when you’re supposed to (on yourappointment day).
You may have to visit the hospital often.

7

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

4

What Happens When I Take the IP?
わかったらなぞろう

Both good and bad things may happen to your health.
< Good things >You may get better.

< Bad things >You may get a stomachache, need to go to the bathroom more often or
get a rash.

The researchers at the hospital will check you more often than usual during
this clinical trial. If you feel sick or don’t feel well, please tell your family rightaway. We will give you a different treatment so you feel better soon!

8Name of Hospital:
Informed Assent Form A
Protocol Number:
Version:Date:

5

If You’re Worried about Anything,Tell Us!

わかったらなぞろう

Please talk with your family and think hard if you want to take the IP inthis trial or not. It’s OK if you don’t want to take part in this trial! If you
decide not to, we will give you other treatments to help you feel better.

Please let us know at any time if you change your mind about taking part.
You can quit this clinical trial at any time after talking with the researchersand your family.

If the researchers find out anything new during the clinical trial, they’ll tell
you right away.

If you have any questions at all, please don’t feel shy
about asking us. We can talk about anything you like!

Contact
Phone number

9Name of Hospital:
Informed Assent Form A
Protocol Number:
Version:Date:

Hospital copy●●●

Letter of Assent●●●.

I have learned everything I want to know about {name of aninvestigational product} and agree to take part in this clinical trial.

Date of your decision://Year / Month / Day

Your name:DoctorExplanation date://Year / Month / Day

Name:

Clinical Research Coordinator
Explanation date:

Name://Year / Month / DayName of Hospital:
Informed Assent Form A
Protocol Number:
Version:Date:

Copy (clinical trial)●●●

Letter of Assent●●●.

I have learned everything I want to know about {name of aninvestigational product} and agree to take part in this clinical trial.

Date of your decision://Year / Month / Day

Your name:DoctorExplanation date://Year / Month / Day

Name:

Clinical Research Coordinator
Explanation date:

Name://Year / Month / DayName of Hospital:
Informed Assent Form A
Protocol Number:
Version:
Date:

Patient copy●●●

Letter of Assent●●●.

I have learned everything I want to know about {name of aninvestigational product} and agree to take part in this clinical trial.

Date of your decision://Year / Month / Day

Your name:DoctorExplanation date://Year / Month / Day

Name:

Clinical Research Coordinator
Explanation date:

Name://Year / Month / Day