FDA
This is what IND and IDE stand for.
What are Investigational New Drug and Investigational Device Exemption?
Who was the first singer to appear on the cover of Rolling Stones magazine?
John Lennon
This is the window in which you may submit a renewal to the IRB.
What is 90 days?
The novel which inspired Theodore Roosevelt to pass the Pure Food and Drug Act of 1906.
What is the Jungle?
Occurs when professional obligations or interests could be undermined or jeopardized by personal interests, such as a financial or fiduciary interest in an entity besides Northwell Health or a personal relationship or interest that may benefit from research or project results.
What is Conflict of Interest (COI)
Act which oversees the safety of food, drugs, and cosmetics.
What is the Federal Food, Drug, and Cosmetic Act?
Helen Keller dedicated her autobiography, The Story of My Life, to whom?
Alexander Graham Bell
This is what HIPAA Form D is used for.
What is preparatory to research/screening prior to consent?
Who was Theodore R. in Night at the Museum?
Robin Williams as Theodore Roosevelt, a wax model of the 26th President of the United States who befriends Larry.
True or False. COI policy and requirements only apply to Investigators and their families.
What is False. This policy applies to all Northwell Health employees, Faculty and Professional Staff.
This FDA form is the equivalent of the 1572 but for device studies instead of drug studies?
What is the investigator Agreement?
This president signed in the Food and Drug Act of 1906
Who is Theodore Roosevelt?
This is where you confirm if an AE is unexpected.
What are the protocol or IB?
This vegetable contains more protein than steak.
What is broccoli?
For most employees, this must be done upon hire or commencement of other relationship (e.g., signing a contract) with Northwell Health, and annually thereafter. Within 30 days of receiving equity or remuneration for a new Extramural Activity or acquiring a new SFI related to Institutional Responsibilities.
What is Submit a Disclosure
Series of amendments which put in force an approval system in which FDA was given the authority to review the effectiveness and safety of a new drug before it could be marketed?
What is the Kefauver-Harris Amendments?
In 1988, the FDA officially became an agency under this department.
What is the Department of Health and Human Services?
This training is required for personnel in a clinical trial and expires every 3 years.
What is Human Subjects Research(HSR)?
In this game, when you pass "GO" you collect $200.
What is Monopoly?
Altering medical records is an example of _______ fraud.
What is Healthcare
This drug was responsible for the death of more than 100 people, which sparked the initiative for drug safety testing.
What is Elixir Sulfanilamide?
McDonald's created this popular food item in 1968.
What is The Big Mac?
This is the process of consenting non-English-speaking subjects.
What are:
Subject and witness sign the short form.
Witness and person obtaining consent sign the English ICF.
The witness must speak both languages.
This is the least populated state in the U.S.
What is Wyoming?
This Federal Law mandated that all health care providers enrolled in Medicare, Medicaid, and Children's Health Insurance Program establish a compliance program as a condition of enrollment.
What is Affordable Care Act or Patient Protection & Affordable Care Act {PPACA or ACA }