Principal Investigator:
Funding Source:
HIC #
Sponsor’s Protocol:
Protocol Version Date:
Subject Name:
Unit Number:
CONSENT FOR PARTICIPATION IN A RESEARCH PROJECT
YALE UNIVERSITY SCHOOL OF MEDICINE - YALE-NEW HAVEN HOSPITAL
TITLE:
INVITATION TO PARTICIPATE AND DESCRIPTION OF PROJECT
You are invited to take part in a research study because you have _____________________.
You have been asked to participate because [explain briefly why the prospective subject is
eligible to participate].
In order to decide whether or not you wish to be a part of this research study, you should know
enough about its risks and benefits to make an informed judgment. This consent form gives
you detailed information about the research study, which a member of the research team will
discuss with you. This discussion should go over all aspects of this research: its purpose, the
procedures that will be performed, any risks of the procedures, possible benefits and possible
alternative treatments. Once you understand the study, you will be asked if you wish to
participate; if so, you will be asked to sign this form.
PURPOSE
The experimental drug being studied in this research study is called ____________. INSERT
BRIEF DESCRIPTION OF DRUG AND PURPOSE OF STUDY.
PROCEDURES
Before starting in this study, there will be a baseline period, which may take up to __ days.
During this time, you will have certain tests and assessments to determine whether or not it is
appropriate for you to participate in this study. These tests include the following: Please list in
bulleted format as below…



A review of your medical history and the medications you are currently taking or have
recently taken
A physical examination and measurement of vital signs (including height, weight,
temperature, heart rate and blood pressure)
1-2 tablespoons (or 15-30 milliliters) of blood will be collected to see if you are eligible
to receive treatment
ICv # :
Reflects: Initial Submission
Submitted:
__________________________________
Patient’s Initials
Page 1 of 8
Principal Investigator:
Funding Source:
HIC #
Sponsor’s Protocol:
Protocol Version Date:
Subject Name:
Unit Number:




A bone marrow aspirate and biopsy (the removal of cells from the bone for examination
under a microscope), which will include routine cytogenetic testing at an outside
laboratory. This testing will provide more information about the genes that may affect
your disease and how you respond to treatment.
A pregnancy test (if you are female and capable of having children)
12-lead Electrocardiogram (ECG – a study of the heart that indicates how well it is
working)
Tumor measurements by CT (computer axial tomography) scan or MRI (magnetic
resonance imaging)
A CT scan is done to locate or watch your cancer. This test takes 30 to 60 minutes. During
the test, you will lie on your back on an X-ray table. A contrast solution, which will allow for
better pictures of your internal organs, may be administered by mouth or through one of your
veins. A strap will be placed across the part of your body that will be scanned to prevent
movement so that the X-ray will be clear. The table will then slide into a large, tunnel-shaped
machine. When the CT scan is finished, you may immediately resume your usual activities.
Your study doctor may order an MRI, which is very similar to a CT scan, since you will lie in a
large, tunnel-shaped machine. However, the MRI does not use X-rays. Instead, it uses radio
frequency waves, similar to those in an AM/FM radio, and a powerful magnet. You cannot
have any metal objects on or inside your body to be able to have an MRI scan.
Complete sections that apply
Treatment
End of Treatment Evaluation
Follow-up
HOW MANY PEOPLE WILL TAKE PART IN THE STUDY?
Approximately ___ patients in the United States and Canada will take part in this study and
approximately ___ patients will be enrolled at Yale University School of Medicine.
ICv # :
Reflects: Initial Submission
Submitted:
__________________________________
Patient’s Initials
Page 2 of 8
Principal Investigator:
Funding Source:
HIC #
Sponsor’s Protocol:
Protocol Version Date:
Subject Name:
Unit Number:
RISKS AND DISCOMFORTS
If you participate in this clinical research study, your study doctor will watch you carefully to
see if you have any side effects. Side effects are possible in any research study despite the
use of high standards of care and can occur through no fault of you or your study doctor. Any
side effects you develop will be watched and treated appropriately by your study doctor. If
new side effects are discovered, your doctor will know about them and share that information
with you. Any new information will be given to you or your legal representative, so that you
can decide whether you want to continue in the study. If you decide that you no longer want to
take part in the study you can do this without any penalty or loss of benefits to which you are
entitled.
Risks of ________ (list risks of each drug separately)
Please list in a bulleted format in the categories of likely, less likely, and rare but
serious.
The following risks should be left in ONLY if they are NOT standard of care!!!
Risks of Biopsies
The risks of biopsy procedures include bleeding, pain, and infection of the biopsy site and with
certain kinds of tumors some of the cancer cells may break off from the tumor lesion and
spread into the biopsy site. This breaking off and spreading of tumor cells would be very rare
with most types of cancer. There is also a low risk of an allergic reaction to the anesthetic, if
you require one.
Risks of Blood Withdrawal
When blood is drawn for testing, you may experience discomfort, bleeding, bruising, or an
infection at the site where a needle was inserted into your vein.
Risks of Bone Marrow Aspirate and Biopsy
When bone marrow is collected for testing, you may experience discomfort, bleeding, bruising,
or an infection at the site where the biopsy needle was inserted into your bone.
Risks of CT Scan
When the contrast medium is injected during the CT scan, you may experience nausea,
flushing, warmth and a salty taste. You might be allergic to the contrast medium, people who
are allergic to seafood or shellfish have a higher incidence of a reaction. Please let us know if
you have these allergies to seafood/ shellfish. The contrast used for the CT scan also has a
risk of causing kidney failure. You must not move during the test, but relax and breathe
ICv # :
Reflects: Initial Submission
Submitted:
__________________________________
Patient’s Initials
Page 3 of 8
Principal Investigator:
Funding Source:
HIC #
Sponsor’s Protocol:
Protocol Version Date:
Subject Name:
Unit Number:
normally. You might be uncomfortable while you are in the tunnel-shaped machine. Some
patients have felt claustrophobic during this test.
Risks of MRI
You may be uncomfortable while you are in the tunnel-shaped machine. You must not have
metal objects in or on your body during the scan as the powerful magnet used during the scan
could exert a damaging pull on them.
WOMEN WHO CAN GET PREGNANT
This drug will harm unborn children and the possible effects on a newborn baby are unknown.
Because of this, you must not participate in the study if you are pregnant, or trying to become
pregnant, or if you are breast-feeding. If you are a female and having a baby is a possibility,
you will be required to have a pregnancy test prior to starting the study. If you are capable of
becoming pregnant, you must use adequate birth control methods while on the study and for 4
weeks following the end of your treatment. You must agree to abstain from sex, use a
condom with spermicide, be surgically sterile, or your sexual partner should be using an
acceptable method of birth control. If you suspect that you have become pregnant while
participating in the study, you must contact the study doctor immediately. You may not
continue in the study if you become pregnant.
MEN WHO CAN FATHER A CHILD
The effects of ______on sperm and sperm production are not known.
Like other
chemotherapies, ______ may cause temporary or permanent sterility (inability to make
someone pregnant). If appropriate, you may want to consider storing sperm in a sperm bank
before receiving ____________.
You should not father a child while you are taking the study medications. You must use
adequate birth control methods or abstinence while on the study and for 4 weeks following the
end of your treatment. You must agree to abstain from sex, use a condom with spermicide, be
surgically sterile, or your sexual partner should be using an acceptable method of birth control.
IN CASE OF INJURY (This language must match the protocol.)
Medical treatment for illness or injury caused by the study drug or study procedures will be
provided to you at no cost, through an agreement between the sponsor and your study doctor.
Compensation for wages or time lost is not available. All symptoms or side effects that you
experience should be reported to your study doctor. You do not give up any of your legal rights
by signing this form.
ECONOMIC CONSIDERATIONS (This language must match the protocol.)
ICv # :
Reflects: Initial Submission
Submitted:
__________________________________
Patient’s Initials
Page 4 of 8
Principal Investigator:
Funding Source:
HIC #
Sponsor’s Protocol:
Protocol Version Date:
Subject Name:
Unit Number:
The cost of evaluations and procedures that are done as standard of care, that are routine and
part of your regular medical care, including any complications of your underlying illness, will be
your responsibility or that of your health insurance.
The sponsor will pay for study-related procedures or tests, those that are not routinely done
during treatment for your disease, or those that are experimental, while you are on this study.
This includes: PLEASE SPELL OUT


Serum pregnancy test
PK sampling (This testing measures the level of Treanda TM in your blood and
determines how it is eliminated from your body.)
Any specimens (for example bone marrow or blood) that are obtained while you are part of
this study may be sent to the sponsor or a group representing the sponsor for review. You will
not be compensated for any information obtained from the analysis of your biological
specimens, nor will you have any financial or property interest in any products or processes,
which may result from research on your biologic samples.
BENEFITS
There may be no direct medical benefit for you. Study drug is an experimental drug for your
type of cancer. It is possible that Study drug may help your cancer. It is possible it will have
no direct benefit to you and that it could make your cancer worse. This trial may help to
develop new and better treatments, and others with your disease may benefit in the future. We
cannot and do not guarantee that you will receive any benefits from this study.
ALTERNATIVES
There are other alternatives to being a part of this study, which could be considered for you.
These alternatives include, but are not limited to, treating your cancer with different drugs or
drug combinations, other type of therapy used to treat cancer, or you can choose to receive no
treatments at all, only care to make you more comfortable.
Should your disease become worse, or the side effects become very severe, or new scientific
developments occur or your study doctor feels that this treatment is no longer in your best
interest, the treatments on this study will be stopped. Your study doctor can provide detailed
information regarding your cancer and the benefits of other treatment options.
CONFIDENTIALITY
Any identifiable information that is obtained in connection with this study will remain
confidential and will be disclosed only with your permission or as required by U.S. or State law.
ICv # :
Reflects: Initial Submission
Submitted:
__________________________________
Patient’s Initials
Page 5 of 8
Principal Investigator:
Funding Source:
HIC #
Sponsor’s Protocol:
Protocol Version Date:
Subject Name:
Unit Number:
When the results of the research are published or discussed in conferences, no information
will be included that would reveal your identity unless your specific consent for this activity is
obtained.
Representatives from the Yale Human Investigation Committee (the committee that reviews,
approves and monitors research on human subjects), the Office of Protocol Review and
Monitoring (OPRM) may inspect study records during internal auditing procedures and during
their annual review. Insert company name/sponsor here if applicable, or their designee will
also have access to the patients records. However, these individuals are required to keep all
information confidential.
Although procedures are in place to protect your privacy, absolute confidentiality cannot be
guaranteed. The information that may need to be reviewed for this study may identify you by
name, address, telephone number, social security number, health plan number, study number,
date of birth, dates relating to various medical procedures, or other identifying information.
The study staff, the study sponsor and their representatives, and anyone else related to the
trial, will need to review the medical information collected from you for this study in order to
accurately record and verify the required study information. In addition, the FDA or Health
Canada and the Institutional Review Board or Ethics Committee that approved this study may
review your medical records for the purpose of verifying data for this study. If you decide to
participate in this study, you will be asked to authorize these uses and disclosures by signing
this form. You must authorize these uses to participate in this study.
You may change your mind and decide to withdraw your permission for the sponsor to use
health information from your medical records at any time by sending a written request to
INSERT MD NAME HERE, Yale Cancer Center, 333 Cedar St. FMP 112, New Haven, CT,
06520. If you withdraw your permission, your participation in the study will end. However, this
withdrawal will not affect your future treatment or medical management in any way, and you
will not lose any benefits to which you are otherwise entitled. The study staff will stop using
your information for the trial, but information already collected up to the time you withdrew your
permission will still be used for the study. Keeping your health information may be necessary
to analyze the study results properly.
Your privacy and confidentiality of the study records will be protected to the fullest extent
provided by law. Research staff on this study will have access to research related information
contained in your study record.
Your experience, while on this trial will be recorded in sponsor-supplied case report forms.
Your name will not be recorded on these case report forms instead a study number will be
used. In addition, a copy of your medical record will be stored at the Yale Cancer Center
Data Management Office (DMO). The DMO is locked and accessible only to staff members of
ICv # :
Reflects: Initial Submission
Submitted:
__________________________________
Patient’s Initials
Page 6 of 8
Principal Investigator:
Funding Source:
HIC #
Sponsor’s Protocol:
Protocol Version Date:
Subject Name:
Unit Number:
that office. Access to the hospital information is limited to clinical staff treating you at the Yale
Oncology Clinic and research staff involved in this study.
VOLUNTARY PARTICIPATION
You are free to choose not to participate and if you do become a subject you are free to
withdraw from this study at any time during its course. If you choose not to participate or if you
withdraw it will not harm your relationship with your own doctors or with Yale-New Haven
hospital.
Before you make your decision, a member of the research team will be available so that you
can ask any questions you have about the research project. You can ask for any information
you want. Sign the consent form only after you have had a chance to ask your questions and
have received satisfactory answers
If you decide to withdraw from this project, please notify a member of the research team
before you withdraw. This notice will allow that person or the research supervisor to inform
you if there are any health risks or special requirements linked to withdrawing.
Questions
We have used some technical terms in this form. Please feel free to ask about anything you
don't understand and to consider this research and the consent form carefully – as long as you
feel is necessary – before you make a decision.
W HERE CAN YOU GET MORE INFORMATION?
You may call the NCI Cancer Information Service at:
1-800-4-CANCER (1-800-422-6237) or TTY: 1-800-332-8615
Visit the NCI Web sites:
CancerTrials: comprehensive clinical trials information http://cancertrials.nci.nih.gov
CancerNet: accurate cancer information including PDQ http://cancernet.nci.nih.gov
ICv # :
Reflects: Initial Submission
Submitted:
__________________________________
Patient’s Initials
Page 7 of 8
Principal Investigator:
Funding Source:
HIC #
Sponsor’s Protocol:
Protocol Version Date:
Subject Name:
Unit Number:
AUTHORIZATION: I have read this form and decided that
______________________________________________________________________
(name of subject)
will participate in the study described above. Its general purposes, the particulars of
involvement and possible hazards and inconveniences have been explained to my
satisfaction. My signature also indicates that I have received a copy of this consent form.
___________________________________________________________
Signature
_____________________________________
Date
_____________________________________
______________________
Signature of Principal Investigator
Telephone
or
____________________________________
_____________________
Signature of Person Obtaining Consent
Telephone
If you have further questions about this project or if you have a research-related problem, you
may contact the study doctor INSERT NAME OF PI AND PHONE NUMBER HERE.
If you have any questions about your rights as a research subject, you may contact the
Human Investigation Committee at (203) 785-4688.
THIS FORM IS NOT VALID UNLESS THE FOLLOWING
BOX HAS BEEN COMPLETED IN THE HIC OFFICE
THIS FORM IS VALID FROM:
_____________________
THIS FORM IS VALID UNTIL:
_____________________
HIC PROTOCOL NUMBER:
_____________________
INITIALED:
_____________________
ICv # :
Reflects: Initial Submission
Submitted:
__________________________________
Patient’s Initials
Page 8 of 8