CTMS Patient Agreement
By signing and submitting this document, I am requesting the Services from Massive Bio; I give my informed consent to Massive Bio to provide the Services to my healthcare provider. I acknowledge that my electronic signature used will result in a legally binding contract under applicable state or federal law.
Amber Specialty Pharmacy and Massive Bio are partnering to oﬀer concierge services to patients, including clinical trial matching services. The purpose of this consent form is to allow your information to be shared between Amber Specialty Pharmacy and Massive Bio to facilitate those services.
Authorization to Release and Disclose (HIPAA Agreement)
By signing below, I am authorizing my health care provider and Amber Specialty Pharmacy to disclose my protected health information (PHI) to Massive Bio and its subcontractor(s). Amber Specialty Pharmacy is also authorized to provide my contact information (name, email, and/or preferred phone number) to Massive Bio, and to communicate with each other related to the services provided. This information would be used to facilitate identification, matching and enrollment in a potential clinical trial based on the CTMS report and analysis. I authorize the release of all medical records, treatment history, medical data, including laboratory test results, tumor measurements, CT scans, MRIs, x-rays, and pathology results, and other clinical information relevant to my disease, other medical conditions that may affect my treatment, information on side effects (adverse events) I may experience, and how these were treated, long-term information about my general health status and the status of my disease, data that may be related to tissue and/or blood samples that may be collected from me; and numbers or codes that will identify me, such as my medical record number. I also authorize Massive Bio to retain and utilize my subsequently de-identified PHI for 1) research and 2) maintenance of the Massive Bio research database, with the exception of records relating to mental healthcare, communicable diseases, HIV or AIDS, and treatment for alcohol or drug abuse. This authorization is being requested by the undersigned individual. I understand and agree to the following:
- This authorization is voluntary, and I may refuse to sign it without aﬀecting (1) my ability to obtain treatment from my health care provider, (2) payment for my health care, or (3) my eligibility for health care benefits.
- Any information disclosed pursuant to this authorization will be used and disclosed by Massive Bio for me and maybe no longer protected by federal or state law. Massive Bio is not a healthcare provider and no patient-provider relationship is established through the request for any of Massive Bio services, nor by the signature of this authorization.
- Treatment decisions are made at the discretion of the treating physician (i.e. primary oncologist) after an independent review of results. Massive Bio is not responsible or liable for these decisions or outcomes from any prescribed diagnostic or treatment interventions.
Massive Bio, Inc. Request for Clinical Trial Matching System (CTMS) Services
I (i.e. the Patient) understand that Massive Bio’s CTMS includes these services (“Services”):
- Contact me to obtain my medical records, treatment history, scans, and clinical information relevant to my disease, followed by review and analysis of my anonymized clinical data by Massive Bio’s CTMS technology tool, and reviewed by their team of experienced oncologists and researchers relevant to the specific disease subtype.
- Provide an analysis report to my primary oncologist that includes potential clinical trial options. Provide the same report, or the subset of the report, to me based on my primary oncologist guidance to Massive Bio.
- Provide a customer support call to me and my primary oncologist to answer any relevant questions and clarifications regarding the released analysis report. My primary oncologist chooses to be present or not during the customer support call
- Concierge support services: In the event the patient is eligible for a clinical trial as determined by CTMS report, Massive Bio will assist me
- Working with my primary oncologist to discuss trial option(s)
- Helping me connect directly with a local site or working with just in time network
- Overcoming logistics and barriers for enrollment such as transportation. Massive Bio cannot pay for my expenses but will assist me finding support with sponsor of the trial
- Working with my designated specialty pharmacy to assist in enrollment to an identified clinical trial. Massive Bio cannot pay for my expenses but will assist me finding support with sponsor of the trial and the specialty pharmacy.
- Working with the trial site research team and doing insurance benefits verification and coverage to decrease any potential trial-related out of pocket expenses
- Finalize all customer support activities within 90 days (3 months) of the execution date of service agreement. In the event of the patient requiring another CTMS analysis due to changes in eligibility compared to the original report, I can reach out to Massive Bio to request such services, when applicable.
- Massive Bio’s Customer Support can be reached at firstname.lastname@example.org or +1-844-627-7246 if you have any questions.
I understand that Massive Bio will perform these services at no cost. I agree that I had the opportunity to review this agreement and clarify all questions before its signature.
I also understand the following disclaimers and limitations of the Services:
- Massive Bio is not practicing medicine and is not licensed, registered, certified, and/or otherwise qualified to practice medicine or deliver medical services in any of the United States of America.
- Massive Bio is not a health care provider and no patient-provider relationship is established by this request for services from Massive Bio.
- Massive Bio disclaims all express and implied warranties, including implied warranties of merchantability and fitness for a particular purpose. Massive Bio does not make any absolute claims or representations regarding the accuracy, completeness, or reliability of its report.
- Massive Bio does not provide medical advice or opinions and our reports are advisory, for educational and informational purposes only.
- Massive Bio is a healthcare data analytics ﬁrm that acts as a vendor to healthcare providers for evaluation of their patient’s existing clinical information and data to provide observations and information about the patient’s disease subtype.
- Massive Bio does not physically observe or examine me, test my blood or tissue samples, or take any anatomical images for diagnostic or therapeutic purposes.
- I represent that the medical records and clinical information provided by me or my healthcare providers are accurate and complete and Massive Bio is not responsible for, or liable to, anyone for incorrect or incomplete reporting due to inaccurate, incomplete, or unreadable clinical information received from my healthcare providers or me.
- Massive Bio will first issue its reports to my primary oncologist, and only after their review and approval, will present the report to me.
- My primary oncologist, in his/her sole discretion, may choose to utilize or disregard the observations and information in Massive Bio’s reports.
- It is my responsibility to work with my primary oncologist to decide on clinical trials, prepare documents, and apply to clinical trials. After the report is released, if there is a specific clinical trial that I would like to enroll in, I will need to apply to the institution for the clinical trial. I will only be accepted for the clinical trial if I am eligible and my condition is suitable. Massive Bio does not guarantee acceptance or enrollment in clinical trials. Massive Bio may answer my questions regarding clinical trials and help prepare documentation as a part of customer support, but I will clearly communicate what I need from Massive Bio and Massive Bio will discuss timing requirements (if applicable).
- Prior to engaging in a customer support call, I shall confirm my identity (name, date of birth, and zip code for identification and security purposes), and shall verbally agree to a disclaimer statement in order to proceed with the call.
- Massive Bio’s report is the product of a proprietary knowledge base and top expert medical oncologists’ input on my anonymized clinical data. Due to proprietary and confidentiality agreements, Massive Bio reserves the right not to disclose the names of the specialists who contributed to the CTMS development.
- After an initial review of my clinical information, if Massive Bio concludes, in its sole discretion, that the Services would not be useful to my primary oncologist or me, Massive Bio may decline to process my request to analyze my anonymized clinical data through CTMS.
- Massive Bio will retain and use my protected health information in anonymized, aggregated form after the Services for research and maintenance of the Massive Bio research database.
- This Request for Services constitutes the entire agreement between Massive Bio and me with respect to this subject matter and shall be construed under the laws of the United States of America and the State of Delaware. All disputes shall be resolved exclusively by binding arbitration held in New York City.
Frequently Asked Questions
What happens if I do not sign this AUTHORIZATION form?
If you do not sign this authorization form, you will not be able to receive any of Massive Bio services. Signing this form is not a condition for receiving medical care, wherever you wish to pursue it.
If I sign this form, will I automatically be entered into a research study?
No, you cannot be entered into any research study without further discussion and separate consent. After the discussion, you may decide to take part in the research study. At that time, you will be asked to sign a specific research consent form.
What happens if I want to withdraw or revoke (cancel) my AUTHORIZATION?
You can change your mind at any time and withdraw your authorization to allow your personal health information to be used in the research. If this happens, you must withdraw your authorization in writing. Beginning on the date you withdraw your authorization, no new personal health information will be used for research. However, researchers may continue to use the health information that was provided before you withdrew your authorization. To withdraw your authorization, please contact the person below. He/she will make sure your written request to withdraw your authorization is processed correctly. Clinical Research Manager RN Phone: +1-917-336- 3319 Fax: +1-844-742-8837 Email: email@example.com
How long will this AUTHORIZATION last?
If you agree by signing this form that researchers can use your personal health information, this authorization has no expiration date. However, as stated above, you can change your mind and withdraw your authorization at any time.
What are my rights regarding access to my personal health information?
You have the right to refuse to sign this authorization form. You have the right to review and/or copy records of your personal health information kept by Massive Bio. You do not have the right to review and/or copy records, analysis, results, or any other data kept by Massive Bio or other researchers associated with any research study derived from this authorization.
I agree that my personal health information may be used for any and all purposes described in this form.