Registration
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Account Registration

PatientCrossroads collects health information in a way that protects your privacy and allows you to control access to your information. To register, you must meet one of the following:

  • Have or be at risk to develop a health condition, be age 18 or older and be able to make your own medical decisions
  • Represent a child or dependent who has or is at risk to develop a health condition and for whom you can legally make medical decisions

Questions about privacy?

INFORMED CONSENT

Sponsor is working together with PatientCrossroads to develop a web-based registry for mastocytosis which will be called Mast Cell Connect throughout the rest of this informed consent. We invite you to take part!

This form is for use in a research study that may involve participants who may or may not have the capacity to consent to take part in the study. Accordingly, when the participant cannot legally consent to take part, pronouns "you" and "your" should be read as referring to the participant rather than the person (legally authorized representative) who is signing this form for the participant.

If you are the parent or legal guardian of a child who may take part in this study, your permission and the permission of your child will be needed.  When "you" appears in this form, it may refer to you or your child.

Create your account today if you meet one of the following:

  • - You have been diagnosed with mastocytosis
  • - You are a family member, medical caregiver or other designee invited by a person with mastocytosis
  • - You are the legal representative for one of the above

Step 1: Create Account

Account Holder

The person entering the data
Information for: Your Relationship to Participant : <p>Please tell us how you are related to the participant.</p>
Information for: Email : Please enter a valid e-mail address. A confirmation email will be sent to this address upon registration.
Information for: Confirm Email : <p>Please confirm your email address by entering it again.</p>
Information for: Username : Please enter a valid username.  No spaces, at least 3 characters and contain 0-9,a-z,A-Z
Information for: Password : Please enter a valid password.  No spaces, at least 8 characters and contain at least 1 lower-case letter, 1 upper-case letter, 1 number, and 1 symbol character
Information for: Re-enter Password : Please enter a valid password.  No spaces, at least 8 characters and contain at least 1 lower-case letter, 1 upper-case letter, 1 number, and 1 symbol character

Step 2: Review the informed consent form

Information about Mast Cell Connect

Before you agree to participate in Mast Cell Connect, it is important that you understand what is involved and what will be done with the information you provide. This form provides information about Mast Cell Connect.

Please read this form carefully. Reading this form and talking to the Sponsor or Mast Cell Connect registry coordinator may help you decide whether to take part or not. Take time to ask the Sponsor or Mast Cell Connect registry coordinator as many questions about Mast Cell Connect as you would like. Their contact information is listed below, and on this form.  For questions about the goals of the Mast Cell Connect registry, contact the Study Doctor at mastcellregistry@blueprintmedicines.com. You can reach the sponsor by telephone 617-714-6678 or 617-714-6707 (24hrs).  For all other questions, contact the Mast Cell Connect registry coordinator at coordinator@mastcellconnect.org.

We suggest that you print a copy of this form for your records. A copy of the information in this form will also be available to you via your website account.

The Registry plans to have about 200 participants.

Purpose of Mast Cell Connect

Mast Cell Connect will store detailed health and other basic information about people with mastocytosis. A registry keeps information in one place making it easier for researchers to share and study information, while still protecting the privacy of those who take part. The objectives of the Mast Cell Connect registry are to:

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

Participating in Mast Cell Connect

In order to participate in Mast Cell Connect, you will be asked to complete online surveys of varying lengths. Surveys will be added based on information that you provide and your participation is ongoing. You will be asked to provide copies of medical reports, such as test results for bone marrow, KIT testing, and/or a doctor’s note. Providing these reports is voluntary and you can participate even if you do not have all of the test results, or if you choose not to provide any medical records. Participants will be able to upload copies of scanned reports, photographs of reports, or electronic health records. Participants may also ask their healthcare providers to provide information about assessments via a secured portal. Reminders will be sent to participants via email and website/app notifications when surveys or other tasks are due or missing. Mast Cell Connect registry staff will contact participants for clarification regarding incomplete or missing assessments. The initial intake survey will include questions to understand the form of mastocytosis the participant has, whether they may be eligible for participation in a clinical trial, and the impact of the disease and its treatment. Additional optional surveys may be added in the future to better understand the impact mastocytosis and its treatment have on people over time. Mast Cell Connect registry staff will notify you at the time when additional surveys are available.

What happens to the information that I put in my account, and who has access to it?

PatientCrossroads will store your information in a secure database. Staff in charge of Mast Cell Connect, including PatientCrossroads, will have access to your records, but other researchers, the Sponsor, and other Mast Cell Connect participants will not be able to see information which identifies you or tells people who you are. Researchers, the Sponsor and other Mast Cell Connect 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" or "de-coded" information will be labeled with a unique code number to protect your privacy.

You may choose whether you share your de-identified answers (no personal identity is shared) for non-study specific survey questions into the pool of other participant answers to advance the understanding of mastocytosis. If you agree to share any information, all personal identifiers, such as your name or email address, are removed before your survey answers are shared. You may choose to share de-identified (no names) information with other databases, such as the National Institute of Health (NIH) or the National Center for Biotechnology Information (NCBI), which may help to expand research on mastocytosis. No study-specific information will be shared outside of the study team. In the event of any publication or presentation resulting from the study, no personally identifiable information will be shared.

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

During your participation in the registry, you may be asked if you are willing to be contacted by the Sponsor or other parties and provide identifying information at that time. In addition, your identifying information may be shared to the extent required by law.

What are the potential risks of participating?

Although PatientCrossroads and the Sponsor 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 Mast Cell Connect. You may receive information that you find helpful, such as information about upcoming clinical trials for mastocytosis. 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 Mast Cell Connect may help researchers gain a better understanding of mastocytosis. The result of this research may guide the future treatment of mastocytosis.

Alternatives to Participating in Mast Cell Connect

Taking part in Mast Cell Connect is completely voluntary—it is your choice. You do not have to join Mast Cell Connect. If you decide not to join, you are still a member of the mastocytosis community. You can continue to receive health care and other support even if you decide not to join Mast Cell Connect.

What if I change my mind about participating in Mast Cell Connect?

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 Mast Cell Connect, you may contact the Mast Cell Connect Coordinator by e-mail at coordinator@mastcellconnect.org. Your account will be deleted; however, information which is collected and de-identified before you decide to withdraw from Mast Cell Connect cannot be retrieved or removed.

How long will my participation last?

Participants are enrolled in the Mast Cell Connect until they choose to stop participating. Mast Cell Connect 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 mastocytosis community. Your participation in this Mast Cell Connect may stop at any time for any reason, such as the Sponsor decides to stop the program. If this happens you will be given the reason at that time.

You will be told about any new information found during the registry that may affect whether you want to continue to take part.

What are the costs of participating in Mast Cell Connect?

There are no costs to join Mast Cell Connect. You will not be paid any money for taking part in Mast Cell Connect.

Who do I contact if I have any questions?

If you have any questions about Mast Cell Connect or about your rights as a participant, you may contact the Mast Cell Connect Coordinator by e-mail coordinator@mastcellconnect.org. If you have any questions or complaints about your rights as a research subject, contact: the Chesapeake Institutional Review Board:

  • By mail:
    • Study Subject Adviser
    • Chesapeake Research Review, Inc.
    • 7063 Columbia Gateway Drive, Suite 110
    • Columbia, MD 21046
  • or call collect: 410-884-2900
  • or by email: adviser@irbinfo.com

Please reference the following number when contacting the Study Subject Adviser: Pro00013750.

A description of this clinical trial will be available on http://www.clinicaltrials.gov/, as required by U.S. Law.  This Web site will not include information that can identify you.  At most, the Website will include a summary of the results.  You can search this Web site at any time.

Confidentiality

To ensure that your information collected for this registry will be kept private, your name will not be used whenever possible. A code will be used instead of your name.  All of your registry data will be kept in a secure location.

The sponsor, the sponsor’s representatives, the Food and Drug Administration (FDA), and Chesapeake IRB may have access to the registry data.

Authorization to disclose health information

If you decide to be in Mast Cell Connect, the study and registry staff will use and share health data about you to conduct the program. Health data may include:

  • Your name
  • Date of birth
  • Medical and health history
  • Symptoms and complications

Health data may come from your medical records and assessments, your questionnaire responses or any additional information that you may choose to provide to Mast Cell Connect. The Sponsor and those working for the Sponsor may access and use only the health data that has been de-identified, meaning all your identifiable information such as your name or birthdate have been removed. The Sponsor may transfer sponsorship of Mast Cell Connect in which case the new sponsor and those working for the new sponsor may access and use the de-identified health data.

Mast Cell Connect may share de-identified health data about you with authorized users. Authorized users may include:

  • Mast Cell Connect study investigators
  • Representatives of Chesapeake Institutional Review Board (an ethics board that reviews the Mast Cell Connect registry)
  • The Food and Drug Administration (FDA) and other US governmental agencies
  • Governmental agencies of other countries
  • Labs working with the Sponsor on this study
  • Other authorized users

The Health Insurance Portability and Accountability Act of 1996 (HIPAA) protect the privacy and security of individual health information. In compliance with HIPAA regulations, Mast Cell Connect has multiple levels of security. These safeguards include data elements (e.g., restricted access to fields), user access (e.g., a password is needed to enter Mast Cell Connect), application (e.g., role-based access to features, access audit trails), and hosting services (e.g., 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 this research will be kept private to the extent permitted by law. However, it is possible that other people may become aware of your participation in Mast Cell Connect. We might have to release your private information in a few specific situations—if it is required by the any of the following:

  • Food and Drug Administration (FDA) or representatives from regulatory agencies in other countries
  • Chesapeake Institutional Review Board
  • Law enforcement officials

The sponsor and those working for the sponsor may use the health data sent to them to:

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

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, 2065.

You may take back your permission to use and share health data about you at any time by contacting the Mast Cell Connect Coordinator by email at coordinator@mastcellconnect.org. If you do this, you will not be able to stay in Mast Cell Connect. No new health data that identifies you will be gathered after your written request is received. However, health data about you that has already been gathered may still be used and given to others as described in this form.

If you decide not to share health data about you to conduct the registry, you will not be able to take part in the registry.

Step 3: Click the appropriate informed consent boxes, enter the security code, and click "Register".

If you are the parent or legally authorized representative of a person with mastocytosis, you may provide informed consent on behalf of the person if you agree to have the person’s information included in Mast Cell Connect. The Legally Authorized Representative is the person legally responsible for the care of the person with mastocytosis.

Please agree to the statements below if you would like to join Mast Cell Connect.

 

Consent Options

Please choose the consent option that applies to the person being registered (select one).

I have read the explanation about Mast Cell Connect and have been given the opportunity to discuss it and ask questions. I hereby consent or give permission for myself or the participant to take part in Mast Cell Connect.

 

Assent Options

Please note that, regardless of the age of the person being registered, everyone must respond to the following two questions in order to participate.  For each question, please choose the assent option that applies to the person being registered:

We request assent if the participant is age 7-17 years and is able to say they want to participate.

Read and choose the assent option For Adolescents 14 – 17 Years Old or choose the reason why this is not applicable

Read and choose the assent option For Children 7 – 13 Years Old or choose the reason why this is not applicable

Terms and Conditions

Please print a copy of this consent document for your records.

Please enter the code below to confirm your acceptance

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