Terms
Regulatory & IP
Budget
Coverage Analysis
Pot Luck
Trial Innovation Network
What about the sites!?!?
100
This clause allows the parties to sign any duplicate, but independent, copies of the contract that will be treated as an original for evidentiary purposes.
What is the Counterparts clause?
100
This is the web site where human subjects research trials must be registered.
What is clincialtrials.gov? Note, effective 1/18/17 HHS requires all of their funded trials to be registered at cliniclatrials.gov along with data outcomes.
100
These cost are paid at the beginning of the study when the contract is executed . They're usually nonrefundable.
What are study start up costs?
100
According to NCD 310.1, Medicare will cover this type of cost (or care) within a study if:
(1) the study’s investigational item/service falls into a Medicare benefit category;
(2) the study enrolls patients with diagnosed disease(s) and;
(3) the intent of the study is therapeutic.
**HINT: A clinical trial patient would have obtained this standard test/service even if they were not enrolled in the clinical trial.**
What are routine costs (SOC, conventional care)?
****NCD = National Coverage Determinations issued by CMS (Center for Medicare and Medicaid Services)****
****LCD = Local coverage determinations are issued by your local Medicare Administrative Contractors***
100
This is the typical number of phases an investigational drug study will go through before going to market (excluding A's and B's).
What is 3 phases? (3 phases before going to market, 4th phase is post market)
100
This is a new collaborative initiative within the CTSA Program and is composed of three key organizational partners – the CTSA Program Hubs, the Trial Innovation Centers (TICs), and the Recruitment Innovation Center (RIC).
What is the Trial Innovation Network?
www.trialinnovationnetwork.org
This is a collaborative initiative within the CTSA Program and is composed of three key organizational partners – the CTSA Program Hubs, the Trial Innovation Centers (TICs), and the Recruitment Innovation Center (RIC). All are key partners of initiative and make unique and essential contributions. Other important partners include NIH Institutes, other federal and non-federal stakeholders, researchers, patients, providers, and the public.
100
This is the person who has authority to delegate specific clinical trial responsibilities to others.
Who is the PI?
200
This clause expressly defines what jurisdiction will govern the interpretation and enforcement of the terms of the contract.
What is the Governing Law clause?
200
According to UIDP (University Industry Demonstration Partnership), approximately, how many years does it take for a new drug to reach the commercial market (from inception)?
What is 15 years?
200
This is a fixed expense of operating a business.
What are overhead (F&A/indirect) costs?
200
This type of analysis is used to ensure compliant clinical research billing.
What is a coverage analysis? (or prospective reimbursement analysis)
200
This is what HIPAA stands for.
What is the Health Insurance Portability and Accountability Act? Additional Information: This act protects your personal health information (PHI) and requires entities to have a Business Associate Agreement (BAA) when sharing PHI with external partners.
200
With funding from the National Center for Advancing Translational Sciences (NCATS), this institution recently established the Recruitment Innovation Center (RIC).
(Hint: Commodores)
What is Vanderbilt University Medical Center?
Recently established the Recruitment Innovation Center (RIC) to investigate ways to address challenges in recruitment and retention of participants in clinical trials.
200
This is the log that must be kept on site that records when a PI gives others authority to do specific clinical trial tasks.
What is the Delegation of Authority Log?
This log should provide a comprehensive list of study staff members and the duties that have been delegated to them by the PI. It is required for both observational and interventional clinical research studies.
300
This clause governs communciations between the site and the sponsor in the event the FDA decides to investigate the study at the site's location.
What is the Audits clause?
300
This is what investigators apply for when using an experimental drug or device in a clincial trial. This is also applied for when a drug or device is being used in an experimental way (ie, different from their FDA approved use).
What is an IND and IDE? IND = Investigational New Drug application IDE = Investigational Device Exemption application
300
According to CMS, this is the value in arm's-length transactions, consistent with the general market value.
What is Fair Market Value?
300
This administrative contractor/person/group issues local coverage determinations (LCDs) that may limit Medicare coverage of specific items and services.
What are Medicare Administrative Contractors (MACs)?
300
This clause governs a party's duty to make good any loss, damage, or liability incurred by another. In federal clinical trials it is rarely provided. In commercial clinical trials we should always request it (even if it is just to protect us against their use of our data).
What is the Indemnification clause?
300
With funding from the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health, these universities established the Trial Innovation Center.
***Note: You can just name one of the five universities***
(Hint: Commodores, Blue Devils, Blue Jays)
What is Duke University, Vanderbilt University, University of Utah, Johns Hopkins University or Tufts University?
Established the Trial Innovation Center to coordinate and provide innovative, high quality operational support for clinical trials. The Trial Innovation Centers are focused on operational excellence, operation innovation, and quality by design.
This is a collaborative initiative within the CTSA Program and is composed of three key organizational partners – the CTSA Program Hubs, the Trial Innovation Centers (TICs), and the Recruitment Innovation Center (RIC). All are key partners of initiative and make unique and essential contributions. Other important partners include NIH Institutes, other federal and non-federal stakeholders, researchers, patients, providers, and the public.
300
NIH calls this the Essential Documents Binder, but it is more commonly known as this.
What is the Regulatory Binder?
(will also accept investigator binder, investigator site file (ISF), and study file)
400
This clause governs what a study participant may be due in the event they are harmed during the course of and/or after completion of the study. Hint: The language in this clause must relatively match what is in the informed consent.
What is the Subject Injury clause?
400
Because of the need for this, sponsors usually make sites wait 12-18 months after the study closes before independent (not multi-site) publications can occur.
What is the data base lock and multi-site data analysis?
(will accept either and anything relatively close to this description :)
400
This is a civil statute that prohibits the knowing submission of false or fraudulent request for payments (claims) to the government.
What is the False Claims Act?
400
The ( ____ ) exemption status of a drug study must be determined by the FDA.
What is the IND exemption status?
21 CFR 312.2(b) (1) is a code of federal regulation that describes the IND exemption status of a proposed clinical evaluation of a drug (e.g. a study). This status must be determined by the FDA.
Studies that qualify for IND exemption: The investigation (1) is not intended to be reported to the FDA as a new study in support of a new indication (or a significant change in the labeling of the drug) (2) is not intended to support a significant change in the advertising of the drug (3) does not involve a route of administration or dosage level that significantly increases risk.
400
With commercial clinical trials, the sponsor will want to own the study data (or at least a broad license to it). However, this is something that you should always try to keep ownership of when negotiating terms related to the study data.
What is source documents/data? (ie, medical records, lab notes, etc..)
400
The Trial Innovation Network provides this service on their website to allow CTSA Program experts to share their expertise on various trial-related topics and encourage collaboration.
(Hint: Today's 2:45p session (NIH Update) was presented in this format).
What are Collaborative Webinars (network events) & the Recruitment Toolkit?
**providing one of the two will suffice***
If you are interested in having your team share expertise, methods and/or best practices to improve the way trials are conducted, you can let the Trial Innovation Network know on their website.
400
These are at least four of the documents you would find in an Essential Documents Binder at the site of a clinical trial.
What are Protocols & Amendments, IRB-Approved Consent Documents, IRB Documentation/Approvals/Correspondence, Investigator Qualification Documentation, Clinical Investigator's Brochure, FDA Documents, Financial Disclosure Forms, study Communications, Delegation of Authority Log, Clinical Research and Study Training, Screening/Enrollment Log, Signed Consent Documents, Study Product Records, Local Clinical Lab Certs, Specimen Tracking Log, SAEs, Protocol Deviations, Clinical Site Monitoring Visits, Sponsor Correspondence, and/or Data Safety & Monitoring Documents?
(Only need 4 for correct answer)
500
This clause usually envokes the Federal Food, Drug and Cosmetic Act and the provisions of 21 CFR §312.70. HINT: It can also ensure you can participate in Medicare/Medicaid and other health insurance programs.
What is the Debarment clause?
500
In commercial clinical trials, this is usually owned by the sponsors (pre-existing) and they will fight you tooth and nail to protect. In addition to this, they will want to own any improvements related to it. It can encompass sponsors' inventions, discoveries, patents, developments, etc...
What is background intellectual property (pre-existing IP)?
500
This is a criminal statute that prohibits anyone from knowingly or willfully paying or receiving remuneration in exchange for referrals or the purchase of any item or service that may be paid for by a federal health care program.
What is the Anti-Kickback Statute?
The AKS is a criminal law that prohibits the knowing and willful payment of "remuneration" to induce or reward patient referrals or the generation of business involving any item or service payable by the Federal health care programs (e.g., drugs, supplies, or health care services for Medicare or Medicaid patients). Remuneration includes anything of value and can take many forms besides cash, such as free rent, expensive hotel stays and meals, and excessive compensation for medical directorships or consultancies. In some industries, it is acceptable to reward those who refer business to you. However, in the Federal health care programs, paying for referrals is a crime. (oig.hhs.gov)
500
NCD stands for...
What is/are National Coverage Determination(s).
500
In addition to a contract amendment, this amendment needs to take place when the protocol is amended, the PI changes, and (but not limited to) an additional site is added. Sometimes a contract amendment is a good indicator that this amendment needs to occur.
What is an IRB amendment (or review)?
500
In alignment with the recent policy changes, the Trial Innovation Network established ____ (#) central IRBs.
(this is a number)
(Hint: (104-98)/2 = ?)
What is three?
Johns Hopkins University School of Medicine
The University of Utah
Vanderbilt University Medical Center
*The CIRBs are charged with promoting faster, more consistent IRB determinations for multi-site studies, as well as developing shared CIRB processes, tools and operating guidelines for investigators and institutions implementing single IRB review. The Network CIRBs are a vanguard in using the SMART IRB Authorization Agreement and will leverage the current SMART IRB efforts to on board all the CTSA Programs to the SMART IRB reliance agreement.
500
This is what CTMS stands for.
What is a Clinical Trial Management System?