Registration
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Account Registration

Join today and together, we can make a difference for those living with anaplastic lymphoma kinase positive (ALK+), non-small cell lung cancer (NSCLC).

There are many benefits to joining the registry and as a member, these include:

  • Discover new research studies.
  • Help researchers better understand life with ALK+ NSCLC.
  • See how your experience compares with others living with ALK+ NSCLC.

To register, you must meet the following criteria:

  • Have a diagnosis of anaplastic lymphoma kinase positive (ALK+), non-small cell lung cancer (NSCLC).
  • Be age 18 or older.
  • Be a resident of the United States, which includes those living in U.S. territories such as Puerto Rico.

Get started now to help the ALK+ NSCLC community!

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Consent

The ALKConnect Registry ("ALKConnect"), sponsored by Takeda Pharmaceuticals ("Sponsor"), and administered by PatientCrossroads ("Administrator") is a web-based registry intended for the ALK+ NSCLC community.  We invite you to take part!

 

Step 1: Create Account

 

Account Holder

There is only one more step. Please verify the following information to confirm that you are the person entering the data into the ALKConnect registry.


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Step 2: Request for Consent

Patient Information Sheet

Informed consent

Consent to take part in a survey study

 

Sponsor / Study Title:

Millennium Pharmaceuticals, Inc. / “ALK Connect Patient Insight Network”

Principal Investigator:

Huamao (Mark) Lin, Ph.D.

Telephone:

(617) 679-7000 (24 Hours)

Address:

Millennium Pharmaceuticals, Inc.

40 Landsdowne Street

Cambridge, MA 02139



Introduction

Takeda is conducting a survey study (sometimes called a registry or observational study) (“ALKConnect Patient Insight Network”) in patients with ALK-positive NSCLC. As the Study is observational, patients that are participating in ALKConnect Patient Insight Network, will not be required to undergo any procedures or tests or receive any investigational drug as part of the Study.

Takeda has hired a company, Invitae, Inc. to manage ALKConnect Patient Insight Network on behalf of Takeda. An Institutional Review Board has reviewed all the related information, including this Informed Consent Form, and has approved ALKConnect Patient Insight Network

You are being invited to take part in ALKConnect Patient Insight Network. Before you agree to participate in ALKConnect Patient Insight Network, it is important that you understand what is involved and what will be done with the information you provide.

Please take sufficient time to read the Informed Consent Form carefully as it will help you decide whether to take part or not. Take time to ask the ALKConnect Patient Insight Network coordinator as many questions about ALKConnect Patient Insight Network as you would like. Their contact information is listed below:

For questions about the ALKConnect Patient Insight Network, contact coordinator@alkconnect.com

You should not join the ALKConnect Patient Insight Network until all of your questions are answered.

ALKConnect Patient Insight Network will store detailed health and other basic information about people living with ALK+NSCLC. The information will be in one central place making it easier for researchers to share and study information, it is expected that 200 patients in the United States will participate in ALKConnect Patient Insight Network.

What is involved in participating in the ALKConnect Patient Insight Network

Once you have decided that you want to participate, you will be provided with information regarding how to set up an account in order to access the database. You will also be asked to electronically sign the Informed Consent Form. Please print out a copy of the signed form for your records. A copy of the form will also be stored in your account in the database.

In order to participate in ALKConnect Patient Insight Network, you will be asked to complete online surveys of varying lengths (approximately 30 minutes for each). To compensate you for your time, you will receive a $50 gift card upon completion of the surveys. Surveys will be added based on information that you provide and your participation is ongoing. In addition, any de-identified data (de-identified means that your personally identifiable information such as your name, date of birth, or contact information are removed) that you have already entered into your ALKConnect Patient Insight Network account including demographic information and survey responses will be used for ALKConnect Patient Insight Network.

What are the potential risks of participating?

Although Invitae will take every precaution to protect your personal information, there is a risk that your privacy may be compromised. In the unlikely situation where this happens, you will be notified right away. Keeping the information from your survey in a secure computer database will limit that risk but does not eliminate it.

What are the potential benefits of participating?

You may not benefit directly from participating in ALKConnect Patient Insight Network. You may receive information that you find helpful, such as information about upcoming clinical trials for ALK+ NSCLC. You will also be able to view de-identified survey information from the pool of other participants that may be useful in better understanding your own disease. The information collected in ALKConnect Patient Insight Network may help researchers gain a better understanding of ALK+ NSCLC. The result of this research may guide the future treatment of ALK+ NSCLC.

Alternatives to Participating in ALKConnect Patient Insight Network

Taking part in ALKConnect Patient Insight Network is completely voluntary—it is your choice. You do not have to join ALKConnect Patient Insight Network. You will not lose any benefits nor be penalized and will continue to receive health care even if you decide not to participate in ALKConnect Patient Insight Network.

What if I change my mind about participating in ALKConnect Patient Insight Network?

You can choose to stop taking part at any time you want—you don’t have to explain why and there will be no penalty or loss of benefits to which you are otherwise entitled.

If you change your mind and no longer want to be part of ALKConnect Patient Insight Network, you may contact the ALKConnect Patient Insight Network Coordinator by e-mail at coordinator@alkconnect.com.

Your account will be deleted and your information will not be used in future analyses; however, information which was collected and de-identified before you decided to withdraw from ALKConnect Patient Insight Network may still be used for the purposes described in this Informed Consent Form

How long will my participation last?

Participants are enrolled in the ALKConnect Patient Insight Network until they choose to stop participating. ALKConnect Patient Insight Network will be an ongoing effort with no end date; it will continue to exist for as long as it is sustainable and useful to the ALK+ NSCLC community. However, ALKConnect Patient Insight Network may be discontinued at any time without notice.

To the extent that the purpose or scope of ALKConnect Patient Insight Network changes, you will receive a written notification and you can decide to continue participating or you can withdraw from ALKConnect Patient Insight Network. Your part in the study can stop at any time for administrative or other reasons.

What are the costs of participating in ALKConnect Patient Insight Network?

There are no costs to join ALKConnect Patient Insight Network. You will not be paid any money for taking part in ALKConnect Patient Insight Network.

Who do I contact if I have any questions?

If you have any questions about the ALKConnect Patient Insight Network or about your rights as a participant, you may contact the ALKConnect Patient Insight Network Coordinator by e-mail at coordinator@alkconnect.com.

This form has been reviewed by an Institutional Review Board (IRB). Advarra IRB reviewed this study to help ensure that your rights and welfare are protected and that this screening is carried out in an ethical manner. If you would like to contact them about your rights as a research subject, their email address is adviser@advarra.com and the toll free number is 877-992-4724. Please reference Pro00025055.

Confidentiality and authorization to disclose health information

As the administrator of ALKConnect Patient Insight Network, Invitae will store your information in a secure database. Invitae staff will have access to your records, but other researchers, the Sponsor, and other ALKConnect Patient Insight Network participants will not be able to see information which identifies you or tells people who you are. Researchers, the Sponsor and other ALKConnect Patient Insight Network participants may have access to your survey answers and other information in the registry only after your identifying information has been removed. Your "de-identified" information will be labeled with a unique code number to protect your privacy.

Reasonable efforts will be made to keep the personal information in your online research record private and confidential, but absolute confidentiality cannot be guaranteed.

If you decide to participate in ALKConnect Patient Insight Network, the study and Invitae staff will use and share health data about you with authorized users to conduct the program. Health data may include your questionnaire responses or any additional information that you may choose to provide to ALKConnect Patient Insight Network. Health data may also include:

  • Your name
  • Date of birth
  • Symptoms and complications

Authorized users may include:

  • ALKConnect Patient Insight Network administrators and other authorized users
  • Representatives of Advarra Institutional Review Board (an ethics board that reviews the ALKConnect Patient Insight Network
  • The Food and Drug Administration (FDA) and other US governmental agencies

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) protect the privacy and security of individual health information. In compliance with HIPAA regulations, Invitae’s administration of ALKConnect Patient Insight Network is based on multiple levels of security. These safeguards include data elements (for example, restricted access to fields), user access (for example, a password is needed to enter ALKConnect Patient Insight Network), application (for example, role-based access to features, access audit trails), and hosting services (for example, firewall, secure sockets layer). These safety features help to make sure that private health information is protected from those who should not have access to it.

Your participation in ALKConnect Patient Insight Network will be kept private to the extent permitted by law. However, it is possible that other people may become aware of your participation in ALKConnect Patient Insight Network and information about you maybe used or disclosed as required by law.

The sponsor and those working for the sponsor may use the de-identified health data to:

  • Further the understanding of the epidemiology of ALK+ NSCLC and its subtypes
  • Improve the collective understanding of the natural history of ALK+ NSCLC and its impact on patients
  • Assist in the development of ALK+ NSCLC therapy by increasing participation in clinical trials and other research studies for patients with ALK+ NSCLC

Once your health data has been shared with authorized users, it may no longer be protected by federal privacy law.

Your permission to use and share health data about you will not end unless required by state law. If state law applies, your permission to use and share health data about you will end on December 31, 2068.

You may take back your permission to use and share health data about you at any time by contacting the ALKConnect Patient Insight Network Coordinator by email at coordinator@alkconnect.com. If you do this, you will no longer have access to or be able to participate in ALKConnect Patient Insight Network. No new health data that identifies you will be gathered after your written request is received. However, health data about you that was provided by you prior to revocation of permission may still be used as described in this form.

The information collected during this study, once de-identified, may be used in the future by the Sponsor and other companies and people working for or with the Sponsor to:

  • develop a better understanding of diseases included in the study; and
  • improve the efficiency, design and methods of future studies.

The results of this study may be presented at meetings or in publications, but your name will not appear in any presentations or publications.

Your right to access your health data in the study records will be suspended during the study to keep from changing the study results. When the study is over, you can access your study health data. If you decide not agree to share your health information, you will not be able to take part in the study.

By consenting, I agree to the following:

  • I have read the informed consent document. I have had the chance to ask questions and I have no additional questions at this time. I acknowledge that should any further questions arise that I am free to email coordinator@alkconnect.com.
  • My participation in this project is entirely my choice. If I change my mind and no longer want to take part in ALKConnect Patient Insight Network, I will be free to do so without having to provide any reason.
  • I agree to share my identifiable health data with the registry and that I may be given a choice to share de-identified information with others outside of the registry.
  • I give my permission for my de-identified data to be made available to the ALKConnect Patient Insight Network study investigators and the Sponsor.
  • I understand the purpose, risks and benefits of participation, and I agree to participate in ALKConnect Patient Insight Network.
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