Registration
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Join the Registry

The registration process is simple and consists of two steps:

Creating your account:

An account can be created by an adult with the diagnosis of primary sclerosing cholangitis (PSC), the parent or legal guardian of a minor or legally authorized representative of an adult patient with the diagnosis, or the caregiver of a deceased PSC patient. For the registration, we will ask a series of questions to confirm your participation and will ask for the name of the account holder. The account holder will create a username and password for the account which are needed to log into the account in the future. The answers to the communication questions may be changed at any time in the future by logging into your account.

Completing the profile:

After creating an account, you can complete the profile. First, enter the name and information for the person with the diagnosis (participant). Next, complete the survey about the participant’s diagnosis, medical history, etc. Once completed, the account holder will be able to add other family members with PSC and complete a survey for each one. You can log out at any time and your answers will be saved. You can log in later to complete your answers.

Please note that you do not have to answer all the questions. "Unknown" means you do not know the answer.

You may find the wording or content of some survey questions not applicable to you. If you are unsure about how to respond to a question, please contact, registrycoordinator@pscpartners.org.

Understanding Your Participation

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Sponsor: PSC Partners Seeking a Cure (PSC Partners)
Title: PSC Partners Patient Registry Informed Consent
Registry Coordinator / Principal Investigator: Rachel Gomel
Email Address: registrycoordinator@pscpartners.org
Address: PSC Partners Seeking a Cure
6900 E. Belleview Ave., Suite 202
Greenwood Village, CO 80111

 

PSC patients worldwide are invited to participate in the PSC Partners Patient Registry. In this document, "Understanding Your Participation," you will receive information to help you decide in making your choice to participate in the PSC Partners Patient Registry. It is important that you clearly understand this document and the "Informed Consent Form for the PSC Partners Patient Registry" that follows this section. It will take you up to thirty minutes to carefully read through these two forms.

Please read the following and the "Informed Consent Form” for the PSC Partners Patient Registry carefully. Please print out a copy and keep this document in your files.

Definitions:

Patient / Participant - refers to a person who has been diagnosed with PSC.

Consent - is a process that informs you how your participation in the registry could affect you, explains information that you need to consider carefully before participating and provides a written record of what you have and have not agreed to. Your consent can be withdrawn at any time, as your participation is voluntary.

You - refers to the person entering the information into the registry. This may be the affected individual, a friend, family member or guardian of the affected individual (the person legally responsible for the care of the affected individual) acting on the affected individual's behalf.

De-identified data - means that all information that can identify you has been removed.

We are asking you to enter personal and other information into the PSC Partners Patient Registry (also called “the registry”). It is important that you understand what is involved and what will be done with the information you provide. This section contains answers to questions about:

  • the information you will be asked to contribute
  • why we are asking for the information
  • how the registry might benefit you
  • possible risks of giving us this information for the registry

After you have read this document, you will be asked to read and complete the “Informed Consent Form” for the PSC Partners Patient Registry. The Consent Form asks a series of questions that determine who can use the information you provide and how it can be used. If you answer “yes” to the question asking you whether you agree to participate in the registry, you will have "consented" to be registered. If you have any questions or concerns, contact the Principal Investigator / Registry Coordinator at the telephone number or email address listed on the first page of this form.

WHAT IS A PATIENT REGISTRY?

  1. The registry is a place where you can collect and store information about your PSC, including medical history and information about other affected family members. You can track information that helps you work with your doctor and other healthcare providers to facilitate management of your personal health.
  2. It is a place where you can include information about your health, including PSC diagnosis, test results (possibly genetic testing in the future), and information on the progress of your disease, so you have access to the most accurate and up-to-date information.
  3. It will enable PSC Partners Seeking a Cure to provide you with the most up-to-date information about research that may be of specific interest to you and other people with PSC, including clinical trials to evaluate possible new treatments.
  4. Researchers studying PSC need accurate information from many people to understand how PSC affects people, information only you and your doctor can provide.
  5. Researchers who are ready to start research studies or clinical trials can use information in the registry to help identify people that may be eligible to participate in studies. If an affected person looks like a good match for a scientist's research or a clinical trial, the scientist or clinical trial coordinator will contact the registry. A member of the PSC Partners’ registry team will then contact you and other individuals identified by the investigator to give you the investigator’s contact information. You will have the choice to contact the investigator or not. Scientists cannot contact you directly, as they only have access to de-identified data.

WHY IS HAVING A PSC PATIENT REGISTRY IMPORTANT?

Primary Sclerosing Cholangitis (PSC) is a poorly understood disease for which there are currently no effective therapies and no known cure. The disease is rare, which makes it difficult to gather information and develop treatments. The registry will collect information from PSC patients all over the world to help researchers have a better understanding of PSC. The rarity of the disease makes it difficult to conduct large clinical trials. That is why PSC Partners has developed a patient registry to collect detailed medical information on PSC patients: to help discover possible factors contributing to disease causes and progression; and to help find and evaluate new therapies.

WHAT IS THE PURPOSE OF THE PSC PARTNERS PATIENT REGISTRY?

The purpose of the PSC Partners Patient Registry is to collect and store medical and other information from individuals with PSC. Information from the registry will be used to better understand PSC and to develop new treatments. This information will be helpful to understand how PSC affects those living with the disease. The registry may lead to studies that help to better understand the natural history (progression) of PSC and/or environmental factors that may contribute to the disease. The registry may also be used by the PSC Partners' registry team to contact patients about clinical trials for which they may be eligible, including those investigating new treatments.

By collaborating with other rare disease registries, the goal is to bring together de-identified information coming from other registries and to find similarities and patterns among diseases. This collaboration may speed up the discovery of new treatments for PSC.

WHAT KIND OF COMMITMENT DO YOU NEED TO MAKE TO PARTICIPATE IN THE PSC PARTNERS PATIENT REGISTRY?

You have the right to know about the procedures involved, and risks, and benefits of participating in the PSC Partners Patient Registry. To participate in this registry, you will need to give your consent after reading this document, “Understanding your Participation.” You will find this statement of consent at the end of the consent form. When you click on the statement affirming your participation and use of the information you are providing, you will have “consented.” If you decide to participate, you can change your mind later and leave the registry. Please take your time to make your decision and discuss it with your family, friends, and caregivers.

The participant may be invited to participate in a clinical trial. Participation in a clinical trial, if the participant qualifies, will be based solely upon the voluntary consent of the patient.

WHOSE DATA ARE YOU COLLECTING IN THE REGISTRY?

The data is collected from individuals who have a diagnosis of PSC, including data about those who have passed away. The diagnosis must be confirmed by MRI or other PSC diagnostic test results.

WHO CAN SIGN THE CONSENT FORM?

You can participate in this registry because you, the PSC patient, or the PSC patient you represent, have been diagnosed with PSC. Patients over the age of 18 who understand the consent form (and who do not have a legal guardian) are eligible to join the registry on their own. Otherwise, the legally authorized representative of an adult patient, legal guardian of a minor, or parent of the patient must give consent for the patient to join. When the patient turns 18, consent for continued participation will be obtained directly from the patient if they do not have a legally authorized representative. Those minors who choose not to re-enroll as adults will have their records deleted from the registry.

WHAT ARE THE STEPS TO JOINING THE REGISTRY?  

  1. You, or your authorized representative, should finish reading this document, "Understanding Your Participation," and then decide if you want to participate in the registry.
  2. If you choose to participate, you, or your authorized representative, will need to complete and sign the Consent Form, affirming that you understand the risks and benefits of participation, and that you agree to participate in the registry.
  3. The next step is to provide basic information about you to create an account with a login user name and password.

Once you create an account, you will be able to access the registry survey. You do not have to complete the entire survey at one time. All your answers will be saved, and you can go back to complete the questions as well as change your answers if you make a mistake or update your information at any time. If you need more than three days to fill the survey, please notify us by writing to registrycoordinator@pscpartners.org.

If more than one family member has PSC, you can create a single-family account. First register one individual with PSC and answer the survey. Then you will be able to add other family members who have PSC to the same account. Each individual family member must provide his or her own consent and enter his or her own data. The value of the family account is to link records from multiple family members who have PSC.

You will be asked to update your registry information at least once a year. The registry will automatically send you a reminder each year, but you can also update your information when you have new information. The registry coordinator may also ask you to mail or upload your test results, and any other relevant reports. Your registry account can be updated whenever there is a change in the patient’s health, change in medication, or new symptom. If the registry coordinator cannot contact you, your account may become inactive.

In the future, the registry may be linked to a biobank which is a place that stores tissue, blood or other samples from patients. If a biobank is created for people with PSC, you may be asked to donate samples to the biobank. If you decide to donate your samples, you will be asked to provide separate consent for the biobank.

WHO WILL HAVE ACCESS TO THE MEDICAL AND OTHER RECORDS IN THE REGISTRY?

The goal of the PSC Partners patient registry is to share detailed medical and other information with scientists and other researchers while protecting your privacy. All of the information you provide will be maintained in a safe (“secure”) HIPAA and Federal Information Security Management Act (FISMA) compliant environment (please see glossary). Any information that could identify you and your family members will not be shared without your approval.

Your privacy will be protected by hiding the name, address and other “identifying” information from researchers. We call this information “de-identified” because all personal identifiers have been removed. Your personal information such as your name, address, or other information that identifies you or your family will be labeled with a code number, encrypted (coded), stored and protected with a password. Only authorized people who work on the registry will know the code and be able to identify you if needed. The PSC Partners Patient Registry is the guardian of the information contained within the registry.

Your identifiable information will not be shared with anyone outside the registry. Approved scientists, researchers, and clinicians will be allowed to see only the de-identified data for their studies. Your identifiable information will not be shared with anyone outside the PSC Partners Patient Registry.

At any time, you may request the PSC Partners Patient Registry coordinator to remove the de-identified data that has been collected in the registry.

Only authorized members of the PSC Partners Patient Registry team will have access to your Identifying information. Only they will see your personal information with a few exceptions that are listed below.

WILL YOUR INFORMATION BE KEPT CONFIDENTIAL?

PSC Partners will make every reasonable effort to assure that your personal information, in our possession, will be kept confidential. However, we cannot guarantee total privacy. Your personal information may be released if ever required by law. If information from the registry is published or presented at scientific meetings, your name and other personal information will NOT be used.

PSC Partners owns the registry data. This registry will be managed by Invitae, a company that manages other rare disease registries like the PSC Partners Patient Registry. Invitae is hosted in a HIPAA and FISMA compliant infrastructure with dedicated firewalls and advanced intrusion detection to secure the participant's data. All registry network transmissions are encrypted for an added level of protection. All transmissions are sent via encrypted SSL (Secure Sockets Layer, i.e. a system of codes that provide communication security over the internet), and personal health information will be encrypted in the database.

Invitae strictly follows the rules and standards provided by the United States Health Insurance Portability and Accountability Act (HIPAA) and Federal Information Security Management Act (FISMA). The Food and Drug Administration (FDA) and New England IRB (NEIRB) may also inspect the registry records. An IRB is a formally recognized, qualified team that reviews and monitors research studies to protect the rights and welfare of research participants.

In the event PSC Partners Seeking a Cure ceases to exist (this is not likely), all attempts will be made to find another suitable entity to take ownership of the registry. You will be asked to give your consent to the transfer of your data (identifiable and de-identifiable information). The data of those not consenting for such a transfer will be destroyed. If all attempts to find a suitable entity fail, then all data collected by the PSC Partners Patient Registry will be destroyed, thus protecting your privacy. You will be contacted and informed of this action.

If you would like more detailed information regarding the security of the PSC Partners patient registry, please contact the registry coordinator at registrycoordinator@pscpartners.org.

WHAT ARE THE RISKS OF PARTICIPATING IN THE REGISTRY?

There is minimal risk in taking part in the registry. The registry includes questions that can be sensitive, and you may feel uncomfortable answering. You do not have to share any information you do not want to share.

There may be risks to your privacy. The PSC Partners Patient Registry will store study records and other information about you in a secure location and will grant access only to personnel authorized by PSC Partners. Compliance to HIPAA and FISMA rules and standards and an annual review of the registry by an Institutional Review Board (IRB) serve to minimize risks to the patient. However, just like other personal information kept by your health care providers, your banks, and others, even these safeguards cannot guarantee absolute protection of the data. If private information gets into the wrong hands, it can cause harm. Although rare, there are reported cases of breaches that have resulted in discrimination in insurance or employment. In the event there is a breach in the registry’s computer system, all participants will be notified. If you would like more detailed information regarding the security of the PSC Partners Patient Registry, please contact the registry coordinator at registrycoordinator@pscpartners.org.

WHAT ARE THE BENEFITS OF PARTICIPATING IN THE REGISTRY?

Providing your information to the registry and participating in this registry are voluntary. Participation may not benefit you personally, medically or financially. However, your participation may help all those with PSC by increasing the understanding of the disease. Collected data may help speed up research. Researchers may learn whether and how treatments work. Medical professionals may be able to improve how they treat the disease. Participants receive information about opportunities to participate in research, clinical trials, medical advances. Participants will also have instant access to de-identified patient survey responses.

WHAT ARE THE COSTS OF TAKING PART IN THIS REGISTRY?

There is no cost for you to participate in this registry. Neither you nor your insurance carrier will be charged for participating in the registry.

DO YOU HAVE TO PARTICIPATE AND CAN YOU STOP PARTICIPATING IN THE REGISTRY?

Participating in this registry is your choice, is completely voluntary, and will not affect your healthcare.

If you decide to participate in the registry, you can decide to stop at any time. Simply contact the registry coordinator at the email address or telephone number listed on the first page of this document, and all of your data will be removed from the PSC Partners Patient Registry. However, pre-authorized de-identified data cannot be retrieved from researchers that have already accessed it prior to your request for removal.

PSC Partners may withdraw you from the registry if circumstances arise which warrant doing so even if you would like to continue.

We will tell you about new information or changes in the registry that may affect your willingness to continue to have your information in the registry.

IF YOU HAVE GIVEN DATA OR INFORMATION TO DOCTORS, RESEARCHERS, CLINICS OR HOSPITALS IN THE PAST, IS IT OKAY TO GIVE YOUR DATA TO THE REGISTRY NOW? 

Yes, it is okay and important to join other registries. Your information will be used differently, for different purposes and by different researchers looking for different aspects of PSC. Your choice to participate or not to participate will not affect the care you are given by your physicians.

WILL YOU BE COMPENSATED FOR BEING IN THIS REGISTRY?

You will not be paid for taking part in this registry. PSC Partners Seeking a Cure maintains ownership of the de-identified data collected and compiled by the registry and is the guardian of the information contained within the registry. You will have no property ownership or interest in such data derived from the registry and no right or entitlement in any research or research product using or derived from the data. However, on the registry site, you will have access to statistics on how others with PSC have responded to questions.

YOU WANT TO BE INVOLVED IN A CLINICAL TRIAL.  IS YOUR PARTICIPATION GUARANTEED?

Although one of the main goals of the registry is to make it easier for PSC patients to participate in research, there is no guarantee that you will be eligible for a trial. Even if you are eligible for a trial based on the data you store in the registry, it is possible that you do not meet all the trial requirements. In order to participate in any trial, you will need to discuss the trial with the research staff and fill out a separate informed consent form specific to the trial. Informing you about the existence of a trial does not imply that PSC Partners endorses it. Before you consent to be in a clinical trial, you should discuss your participation with your physician.

YOU DON’T WANT TO BE INVOLVED IN A CLINICAL TRIAL.  SHOULD YOU STILL REGISTER?

Even if you do not want to take part in a clinical trial, your de-identified information will still be useful to researchers who are trying to learn more about patients with PSC. By joining the registry, you will be helping to better understand the geographical spread of the PSC population, the progression of disease, evaluation of treatments and tests, monitoring the safety of medications, and more.

INTERNATIONAL USERS

PSC Partners Seeking a Cure makes no claims that information in the PSC Partners Patient Registry is appropriate or may be downloaded outside of the United States. Access to the registry may not be legal in certain countries or for certain persons. If you access the registry from outside of the United States, you do so at your own risk and are responsible for compliance with the laws of your jurisdiction regarding online conduct and acceptable content. User personal information ("Information") that is submitted to this registry will be collected, processed, stored, disclosed and disposed of in accordance with applicable U.S. law and the PSC Partners Patient Registry Privacy Policy.

The PSC Partners Patient Registry is operated by Invitae, a US corporation that manages other registries. PSC Partners Patient Registry is the sole owner of the data. Invitae makes no representation that materials in the registry are appropriate or available for use in all locations worldwide. You are solely responsible for compliance with local laws, if and to the extent local laws are applicable. Access to the registry from jurisdictions where the contents of our registry are illegal or penalized is prohibited.

If you are a non-U.S. user, you acknowledge and agree that the PSC Partners Patient Registry may collect and use your de-identified information and disclose it to other entities outside your resident jurisdiction. In addition, such information may be stored on servers located outside your resident jurisdiction. US law may not provide the degree of protection for information that is available in other countries. By providing us with your de-identified Information, you acknowledge that you consent to the transfer of such information outside your resident jurisdiction to the US or other jurisdictions that may require different levels of protection. If you do not consent to such transfer, you may not use the registry.

WHO SHOULD YOU CONTACT IF YOU HAVE ANY QUESTIONS?

If you have any questions about the registration process, about participation in the registry, or about reporting problems that result from your participation in the registry, please contact the registry coordinator at registrycoordinator@pscpartners.org.

To inquire about your rights as a participant in the registry, you may also contact New England IRB by emailing info@neirb.com or by calling 1-800-562-4789.

As you complete the registry survey, if you have questions that you do not understand, first go to the Glossary tab found at the top, and if you have further questions, please contact the Registry Coordinator at registrycoordinator@pscpartners.org.

For additional information regarding the terms and conditions of the registry website or the privacy policy, please go to Terms and Conditions and Privacy Policy. You will find the statement of consent at the end of the Informed Consent Form.

By clicking to agree to participate on the "Informed Consent Form", you do not give away any legal rights or benefits to which you are otherwise entitled. 

By clicking to agree to participate on the “Informed Consent Form”:

  • You have read and understand the information above
  • You have had the opportunity to ask questions
  • You have had time to consider fully whether you want to join the registry
  • You have consented to participate

Informed Consent

Use the following form to enter or update your consent choices.

Asterisk (*) means questions are required

For the purpose of this document "I" and "you" refer to the registrant, either the individual affected by primary sclerosing cholangitis (PSC) or the parent, guardian or family member providing the information on behalf of the affected individual (the person legally responsible for the care of the affected individual).  "The registry" refers to the PSC Partners Seeking a Cure patient registry.

All of the following questions must be answered in order to participate in the registry.

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Parent or Legal Guardian’s consent for minor: 

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Account Information

Use the following form to update your account information, contact email, and to change password.

* This Field is required Information for: Your Relationship to Participant : <p>Please tell us how you are related to the participant.</p>
* This Field is required Information for: Email : Please enter a valid e-mail address. A confirmation email will be sent to this address upon registration.
* This Field is required Information for: Confirm email : <p>Please confirm your email address by entering it again.</p>
* This Field is required Information for: Username : Please enter a valid username.  No spaces, at least 8 characters and contain 0-9,a-z,A-Z
No spaces, at least 8 characters and contain at least one lowercase letter, one uppercase letter, one number and one special character.
* This Field is required Information for: Password : Please enter a valid password. No spaces, at least 8 characters and contain at least one lowercase letter, one uppercase letter, one number and one special character. For example: Example@1. In an effort to maintain security, you will be required to reset your password at regular intervals
* This Field is required Information for: Re-enter password : Please enter a valid password. No spaces, at least 8 characters and contain at least one lowercase letter, one uppercase letter, one number and one special character. For example: Example@1. In an effort to maintain security, you will be required to reset your password at regular intervals

 

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