Understanding Your Participation

Understanding Your Participation

For the purpose of this Consent Form, “patient” will refer to the person diagnosed with cholangiocarcinoma. “You” will refer to the person entering the information. You may be the patient, a family member or a legal guardian of the patient (the person legally responsible for the care of the patient).

The Cholangiocarcinoma Foundation is requesting that you enter personal and other information into the International Cholangiocarcinoma Patient Registry (ICPR). Participation in the ICPR is completely voluntary. It is important that we explain what information is required for the “patient” to be involved and what will be done with the information you provide.

The following section contains answers to questions about the information we are requesting, why we are gathering information, how it might be used, what if any benefit there may be to you, and possible risks of sharing this information. After you have reviewed “Understanding Your Participation” you will be directed to the Patient Consent Form. You will be asked a series of questions. By answering “yes” to the required questions regarding your voluntary participation and understanding of the purpose, risks, and benefits of sharing your information, you are giving your “consent” to become a registered ICPR participant. Participation in the ICPR is optional and at the complete discretion of the “patient”. If you have questions that are not answered in this document, please contact the ICPR Coordinator at  This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

What is a patient registry?

A patient registry is a place to store detailed information about individuals with a specific disease and/or syndrome. In this case, the ICPR is for individuals diagnosed with cholangiocarcinoma (bile duct cancer). Establishing the ICPR addresses two critical needs. First, scientists studying cholangiocarcinoma need accurate, first-hand information to understand how cholangiocarcinoma and its treatments affect people. Second, scientists who are ready to start studies, such as those which test new treatments, will have the ability to access the ICPR to identify people that may be eligible to participate in studies. If a patient looks like a good match for a scientist's research, the scientist will contact the ICPR. The ICPR Coordinator will then contact the patient, giving them preliminary study information. Scientists will not contact patients or their families directly. Participation in any study or trial cannot be guaranteed, even if the patient initially seems to be a good candidate. Participation in any study or trial is also completely voluntary and at the discretion of the patient who is free to decline at any time.

What are the benefits of collecting patient's information in a registry?

Although there are no direct benefits paid or given to any individual participating in the registry, the collection of information on patients in the ICPR will aid scientists to:

1. Study why individuals have different symptoms
2. Gain information about how/why/when certain treatments work or don't work
3. Help medical professionals improve how/when they treat patients with cholangiocarcinoma
4. Speed up research in cholangiocarcinoma by collecting information for scientific use
5. Screen appropriate individuals who may be eligible for clinical research studies and/or clinical trials

Whose data are you collecting?

We are collecting information from individuals who have been diagnosed with cholangiocarcinoma, including those who have passed away.

Who can sign the consent form?

Patients over the age of 18 (who are fully competent to enter into a legal agreement) are eligible to join the ICPR on their own. Otherwise, the legal guardian, parent, or legally entitled survivor of the patient must sign the Consent Form for the patient to join the ICPR. When the patient becomes 18 (and if they are able), consent will be obtained directly from the patient for continued participation.

Steps to filling out the ICPR with patient’s information

  • Step 1 - If you are the patient, or the affected person's legally authorized representative, you should first finish reading, “Understanding Your Participation,” then; decide if you want to participate in the ICPR.
  • Step 2 - If you would like to participate in the ICPR, review the Terms and Conditions and Privacy Policy then submit this completed Consent Form.
  • Step 3 - You will need to provide some basic information about yourself to create a username and password. You will then be directed to the registration form where you will include your contact information and other basic demographic information.
  • Step 4 - Next, you will be directed to additional sections or modules of questions that you can answer all at once or complete one section at a time, until you have finished the entire survey.

If more than one family member has cholangiocarcinoma, you can create a single-family account. First register the patient with cholangiocarcinoma and complete the survey. You will then be able to add other family members with cholangiocarcinoma.

Will I be expected to provide the ICPR with additional information in the future?

Yes. The ICPR is most valuable for scientific research when it is kept up-to-date. Therefore, you will be asked to update your profile and information. We will send out notifications bi-annually to remind you. We may also ask you to fax or upload any additional test results, and/or any other relevant reports. The ICPR can also be updated whenever there is a change in condition, medication, treatment(s), and/or new symptom(s).

Where will the data go?

The ICPR follows strict rules to protect your personal information. All of the information you provide to the ICPR will be maintained in a secure database, and any information that can identify you will not be shared without your prior written consent, unless otherwise required by law.

Who will have access to the medical and other records on the ICPR?

The goal of the ICPR is to make the information you provided searchable, while concurrently protecting your identity. De-identified (coded and anonymous) data gathered from the ICPR may be made available to approved doctors, researchers, scientists, clinicians, pharmaceutical companies, or other registry participants.

A subset of de-identified information collected from each profile may be shared with selected additional relevant databases, including the Global Rare Diseases Patient Registry and Data Repository. The ICPR may combine our de-identified data with other databases in order to develop global knowledge of cholangiocarcinoma, which we hope will lead to new research studies, clinical trials, and treatments.

The de-identified data collected and compiled by the ICPR belongs to The Cholangiocarcinoma Foundation. The Cholangiocarcinoma Foundation is the guardian of the information contained within the ICPR.

What are the risks to registering?

There is minimal risk in taking part in the ICPR. The ICPR includes questions that can be sensitive and you may feel uncomfortable answering. You do not have to share any information you do not wish to. Another unlikely risk is potential breaches in the computer system. In the event that there is a breach in the ICPR computer system, all participants will be notified.

I want to be involved in a clinical trial. If I register, is this guaranteed?

Although one of the main goals of the ICPR is to make it easier for patients to participate in research, there is no guarantee that any patient will be eligible and/or selected for a trial.

(Please note that even if the coordinators of a clinical trial believe that you might be eligible for the trial, based on the data about you stored in the ICPR, it is still possible you will not ultimately meet the trial inclusion criteria to participate. Additionally, please be aware that if The Cholangiocarcinoma Foundation informs you about the existence of a trial, this does not imply that we endorse it. In order to participate in any trial, you will need to fill out a separate Informed Consent Form.)

I DO NOT want to be involved in a clinical trial. Should I still register?

Absolutely, we hope that you will still be willing to register, even if you don't want to take part in a clinical trial. Your information may still be useful to researchers who are trying to learn more about patients with cholangiocarcinoma.

Can I withdraw if I change my mind?

Absolutely, your participation in this project is entirely voluntary. Should you change your mind and wish to withdraw your data from the ICPR, you will be free to do so at any time and without having to provide any explanation. Simply contact the ICPR Coordinator at This e-mail address is being protected from spambots. You need JavaScript enabled to view it and all of your data will be removed from the database. However, data accessed prior to your request for removal cannot be retrieved from researchers that have already accessed it.

If I have already given data or information to doctors, researchers, clinics or hospitals in the past, is it OK to give my data to the ICPR now?

Yes. We will be taking precautions to make sure information used is not redundant with data that may have previously been collected.

What are my options if I do not want to be in the ICPR?

You do not have to join the ICPR. Participation is completely voluntary. You do not need to participate in the ICPR to remain a member of The Cholangiocarcinoma Foundation community, or to access any of The Cholangiocarcinoma Foundation patient resources.

Will it cost me anything to be in the ICPR?

No. There are no costs to join the ICPR.

Who should I contact if I have any questions?

If there are questions in the ICPR that you do not understand, first go to the Glossary tab for more information. If you have further questions, please contact the ICPR Coordinator at  This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

If you have any questions about the registration process or about participation in the ICPR, please contact the ICPR Coordinator at  This e-mail address is being protected from spambots. You need JavaScript enabled to view it .

For additional information regarding the Terms and Conditions of this web site or the Privacy Policy please go to Terms and Conditions |Privacy Policy.