Informed Consent Form
Title

“Patients receiving Neratinib in the Extended Adjuvant setting for the Treatment of HER2-overexpressed/amplified breast cancer: a Virtual Registry (Neat-HER)”

Protocol Number

PUMA-NER-7401

Study Sponsor

Puma Biotechnology, Inc.

Name of Person In Charge of the Research Study (Investigator)

Noga Leviner

Daytime / After Hours Telephone Number

(415) 801-0572

Introduction

You are invited to take part in an observational research study (also known as a non-interventional study) using your medical data.  You are invited to join this study because you are currently receiving NERLYNX® (neratinib) treatment for HER2+ early-stage breast cancer.  This document describes the purpose of the study and how your data will be used.  Please read the following information carefully.

What is this study?

This observational research study looks at medical data that has already been collected and kept in your medical records from routine medical care.  No new medical data about you will be collected in this study. Medical records including but not limited to labs, notes, medications and care plans for subjects going backwards as far as electronic records are available and forward for 3 months after the completion of NERLYNX® (neratinib) treatment from all participants will be gathered and analyzed.  Data will be collected by PicnicHealth and will be analyzed by Puma Biotechnology.

What is the purpose of this study?

The purpose of this observational research study is to better understand the health of people in the United States who are currently receiving NERLYNX® (neratinib) for the treatment of HER2+ early or adjuvant breast cancer.

Who is funding this study?

Puma is providing financial support to PicnicHealth to cover the cost of retrieving medical data for this study. The study principal investigator is the co-founder of PicnicHealth. However, the consent process is online and he/she is not involved in analysis of the data by Puma.

Has this study been approved?

Yes. This study has been reviewed by IntegReview IRB, an organization that is responsible for protecting the rights, safety, and well-being of patients who take part in research studies.

How many people will participate in this study?

Approximately 100 adult female and male patients over the age of 18 years will participate in this study.

How much time will this study require of me?

It will take approximately 10-15 minutes to finish signing up for this study.  The study will continue for up to 2 years. You will not need to participate further in any activity.

What do I need to do if I participate in this study?

If you agree to participate in this study, you will be asked to

  • Authorize PicnicHealth to collect your medical records on your behalf
  • List your healthcare providers (doctors, hospitals, and/or clinics)

What will happen if I participate in this study?

1. You will be asked to sign this Informed Consent Form and provide your medical release to all providers. Only then will data form your medical records be extracted and analyzed as part of this study. This data is already kept in your medical records, whether or not you participate in this study.

2. You will receive PicnicHealth’s medical record retrieval and management services for the study duration. Puma Biotechnology will pay for PicnicHealth’s services.  Neither you nor your insurance company will be billed for PicnicHealth’s services.  As part of these services, PicnicHealth will:

  • Collect your historic medical records on your behalf from the healthcare providers that you authorize
  • Digitize your medical records so that you can access all of them online through your PicnicHealth timeline
  • Enable you to electronically share your medical records with your doctors, caregivers, and family. You will be able to view your medical records data (e.g., lab results, prescriptions, and imaging files), download copies of records, and share your records with your doctors.
  • Collect your ongoing medical records on your behalf from the doctors who continue to provide care for you for three months after you complete treatment with NERLYNX® (neratinib) but for a year at a minimum.
  • After 2 years, the study will end. Medical records will be kept for 10 years in secure computer files and servers. All data will be password protected. You may continue to access your existing medical records through your PicnicHealth account but no new records will be added.  You can request that your data is deleted from the PicnicHealth service at the end of the study, or at any time before or after the end of the study.

3. Personally identifying information, such as your name or date of birth, will be removed before your data are analyzed for this study.  The data without your personally identifying information are referred to as “de-identified data.”  

4. Your de-identified data will be shared with Puma to better understand the health people who receive NERLYNX® (neratinib).  For this purpose, your de-identified data will be aggregated (combined) with those of the other study participants.

What data will be used in the study?

The following information will be extracted from your existing medical records from the past 7 or more years and from your medical records in the 3 months following the date you complete NERLYNX® (neratinib) treatment:

  • Demographics (gender, date of birth, etc.)
  • Medical history (other diseases you may have or have had)
  • Results of physical examinations
  • Vital signs (heart rate, body temperature, etc.)
  • Blood tests and other laboratory tests
  • Imaging
  • Medications and treatment history
  • Doctor’s notes

Are there benefits to participating in the study?

There is no direct medical benefit to you from being in this study.  The information gained from this study may help scientists and doctors to learn more about the health of people who receive NERLYNX® (neratinib).

You and other people who receive NERLYNX® (neratinib) may benefit from results of this research in the future.

You will receive free access to PicnicHealth’s medical record collection and management services for the study duration.  As part of these services, PicnicHealth will:

  • Collect your historic medical records on your behalf from the healthcare providers that you authorize
  • Digitize your medical records so that you can access all of them online through your PicnicHealth timeline
  • Enable you to electronically share your medical records with your doctors, care givers, and family
  • Collect your ongoing medical records on your behalf from the doctors who continue to provide care for you

To learn more about PicnicHealth’s services, you can visit https://picnichealth.com/Neat-HER.

What other choices do I have if I do not participate in this study?

You can choose not to participate.  Your medical data will not be used and you will not receive PicnicHealth’s medical record collection service.  This will not affect in any way the regular care you receive from your doctors.

Will I be paid for participating in the study?

You will not be paid for taking part in this study.  You will receive PicnicHealth’s medical record retrieval and management services for the study duration. You will receive PicnicHealth’s service regardless of your course of treatment. PicnicHealth will collect and digitize your medical records and make the records available to you through the PicnicHealth timeline.  After the study ends, you can continue to access your existing medical records through your PicnicHealth account.  After the study ends, no new records will be added unless this study is extended, or you choose to subscribe to the PicnicHealth service at your own expense.  You can request that your data be deleted from the PicnicHealth service at that time, or at any time before or after, but your data cannot be deleted from the study once it has been collected.

Are there any risks if I participate in this study?

There are no physical risks from participating in this study.  There may be privacy and confidentiality risks.  Despite best efforts, it is not possible to guarantee that your personally identifiable information (e.g., name, date of birth) will never become known.  For example, data may be vulnerable in transit or servers may be accessed by unauthorized individuals.  However, the risk for such a confidentiality breach is low. Your private health information will be kept secure as below.

How will my information be kept private?

You will be assigned a unique patient identification number.  The medical data used for this study will be labeled with this identification number; the data will not be labeled with your name, picture, or any other personally identifying information.  The de-identified data will be kept in data warehouses within Puma Biotechnology.  No person will be identified in any report or publication from this study.

National applicable laws and regulations to protect the personalized data in your medical records will be strictly followed.

People that may look at and/or copy your medical records for research, quality assurance, and data analysis include:

  • PicnicHealth personnel directly involved with the medical data retrieval processes
  • The Institutional Review Board responsible for protecting the rights and safety of the patients who take part in research studies
  • Regulatory health authorities (government agencies involved in keeping research safe for people)

How will health information that could identify me be used and disclosed?

If you sign this consent form, you give permission to PicnicHealth to use or disclose the health information in your medical records only for the purposes of this research study.  No names or personally identifying information will be disclosed to Puma.  Your authorization to use and disclose your health information does not have an expiration date, but that usage will only be for the purposes described in this consent form.

Health information that identifies you may be disclosed to the Institutional Review Board, and representatives of the US Food and Drug Administration (FDA) or other national and local health authorities.

You may change your mind and revoke (take back) this authorization at any time, without penalty or other consequence.  If you revoke this authorization, no additional health information will be retrieved about you.  However, any data that has already been retrieved, up until the time you notify PicnicHealth to revoke your authorization, will remain accessible to Puma.  These data will not include your name or personally identifying information.

If you leave the study, you can choose to purchase and continue using PicnicHealth’s medical record collection and management services, independent of the study.  If you use PicnicHealth independent of the study, you can authorize PicnicHealth to collect your medical records for your personal use and care coordination.

Will I receive the results of this study?

Yes, you will receive the published results of this study.  The results will be made available to you online on the study website or through email sent by PicnicHealth.

Who can answer my questions about this study?

If you have questions, concerns, or complaints about this study or to report a study related injury, contact:

PicnicHealth

Email: Neat-HER@picnichealth.com

Phone: (415) 801-0572


If you do not want to talk to PicnicHealth, or if you have concerns or complaints about the research, or if you want to ask about your rights, you may contact IntegReview.  IntegReview’s policy indicates that all concerns/complaints are to be submitted in writing for review to:

Mailing Address:

Chairperson
IntegReview IRB
3815 S. Capital of Texas Highway
Suite 320
Austin, Texas 78704

Email: integreview@integreview.com


If you are unable to provide your concerns/complaints in writing or if this is an emergency situation regarding subject safety, contact IntegReview’s office at:

Phone: 1-512-326-3001 (between 8 am and 5 pm Central Time) or toll free at 1-877-562-1589

IntegReview has approved the information in this consent form and has given approval for the investigator to do the study. This does not mean IntegReview has approved your being in the study. You must consider the information in this consent form for yourself and decide if you want to be in this study.

VOLUNTEERING TO BE IN THE STUDY

It is your choice if you want to be in the study.  No one can force you to be in the study.  You may not want to be in this study or you may leave the study at any time without penalty or loss of benefits to which you are otherwise entitled.  
The investigator, the sponsor company, or IntegReview may take you out of the study without your permission, at any time, for the following reasons:

  • If you do not follow the investigator’s instructions
  • If we find out you should not be in the study
  • If the study is stopped

COSTS

There are no additional costs to be in this study. You are still responsible for the costs of medical care and treatment for your disease.

LEGAL RIGHTS

You will not lose any of your legal rights by signing this consent form.

NEW FINDINGS

If there is new information or any significant new findings that could relate to your willingness to continue participation, we will tell you. You can then decide if you still want to be in the study.

SUBJECT'S BILL OF RIGHTS

You will be given a separate copy of the California Experimental Research Subject’s Bill of Rights.  If you have not received a copy of this document, please notify study staff.

THE REASON FOR INSTITUTIONAL REVIEW BOARDS AND INFORMED CONSENT

What is a consent form?

The informed consent document contains information required by federal regulations. The informed consent document must be approved by an Institutional Review Board (IRB).

What is an Institutional Review Board (IRB)?

An Institutional Review Board (IRB) is a group of people that reviews research studies. The main goal of this review is to protect the rights and well-being of the human subjects participating in research studies.

IntegReview, the IRB for this study

IntegReview is an IRB whose board members provide IRB services across the United States, Latin America and Japan.

To meet requirements of the law, the IntegReview Boards currently include:

  • Doctors
  • Pharmacists
  • Nurses
  • Toxicologists (people who study the harmful effects of chemical)
  • Other specialists
  • Others who do not have a background in science/medicine
You have the right to access an electronic copy of this entire form after it has been signed.
PARTICIPATION IN RESEARCH IS VOLUNTARY. You have the right to decline to participate or to withdraw at any point in this study without penalty or loss of benefits to which you are otherwise entitled.