The FDA recommends all risk characterizations should follow TCCR Principles. Which of the following are NOT terms represented in this acronym? CHOOSE ALL THAT APPLY OA, reasonableness B. relevance OC. tactfulness OD. clarity E, candidness OF, transparency G. consistency
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Risk characterization is a crucial step in the regulatory decision-making process, especially in areas like food safety and public health. For risk characterizations to be carried out with a high level of integrity and efficacy, the U.S. Food and Drug Administration (FDA) advises following a set of guidelines that are commonly denoted by the acronym TCCR. These guidelines serve as the cornerstone of open, understandable, and consistent risk assessments, which support well-informed decision-making procedures. Examining these concepts and determining which terms are absent from the TCCR acronym will help us understand the particular attributes that the FDA believes are essential for reliable risk assessments.
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- In the context of a case control study, matching can help you: a. Eliminate random error b. Ensure a large sample size c. Ensure comparability between cases and controls d. Study the factors you match on as potential exposuresWhy is organizational culture the most critical element concerning EHR adoption? A. The organizational culture must be ready to support adoption by the individuals within it. B. Implementing an electronic health record can be a difficult task to take on, and planning the process is of utmost importance to minimize errors. C. The staff of an organization needs to provide input into the selection criteria and implementation plan of an EHR system. D. To ensure areas of possible staff confusion are identified and controlledThe Food and Drug Administration (FDA) is responsible for: A. Requiring drug manufacturers to provide notice that a new drug is safe. B. Recalling pharmaceuticals only after harm has occurred. C. The approval before a new drug can be marketed. D. The assumption that the manufacturer of drugs would have conducted safety tests before marketing a new drug and protocols have been established.
- Customized medications are: Select one: O a. O b. O C. O d. Formulations that meet a patient's therapeutic needs F3 Formulations that can only be manufactured pursuant to a prescription Formulations that only contain non-medicinal ingredients Formulations that contain API's listed in the CPS mod/quiz/attempt.php?attempt=186101&cmid=102359&page=44# F4 F5 0 Q Search F6 1 L 160 के alel ETo get approved by the FDA generic drugs have to demonstrate the following: That their bio availability is the same as brand name drug That their bio equivalence is the same as the brand name drug That their bio availability AND bio equivalence is the same as the brand name drug None of the aboveWhich of the following is a barrier to recruitment in a clinical trial? A. Investment in community education and outreach. B. Education about clinical trials early in a patient's diagnosis. C. Presentation of options for the patient. D. Strick protocols and narrow eligibility guidelines.
- Clinical trials can be designed to demonstrate that a new technology offers measurable, relevant benefits, in terms of safety, clinical effectiveness, and in some instances, cost-effectiveness True False14. Explain the importance and describe the process for carrying out a risk assessment (relate this to a real example from practice) Type your answer here: Risk assessment U ос Or5. Claims for any medical device do not need to be supported by data for commercialization. A. True B. False 6. For a drug-device combination product approval, the FDA allows device testing using a placebo instead of an actual drug if the drug is costly. A. True B. False 7. Sharing product information on Twitter without data support is acceptable since Twitter is a social media, not an actual rug packaging. A. True В. False Page 5 of bedo e o
- 1. Which of the following makes it especially difficult for veterinarians to determine if an opioid is truly indicated? A. Opioids used in veterinary medicine are not used in human medicine B. Our patients can’t talk C. Our patients always require larger doses than humans D. All of the above 2. Which of the following is/are potential problems with PDMPs in veterinary medicine? A. Determining how to report the data B. Potential HIPPA violations when reviewing the system seeing the client’s medical information C. How to tie pets to the people that we are trying to monitor D. All of the above 3. Which schedule of controlled substance has no accepted medical use? A. CI B. CII C. CIII D. CIV 4. Which state specific regulatory agencies do you need to be familiar with to know how they regulate controlled substances at the state level? A. Local DEA Field Office B. State Board of Pharmacy C. State Veterinary Board D. All of the…3. An ongoing clinical protocol at your site includes weekly blood draws to assess an exploratory endpoint. Unfortunately, participants are not happy about visiting the clinic weekly, and they are considering dropping out. Therefore, a protocol amendment is being prepared to remove the weekly blood draw. This change can be implemented: O A. Immediately, as it is not a safety assessment. O B. Once the protocol is finalized and submitted to the FDA. O C. Once the protocol and consent form updates are approved by the IRB. O D. As soon as the study sponsor advises that their decision is final to remove these blood draws. If already serving as a member of the IRB, a clinical investigator can participate in the review of her own clinical protocol. O A. TRUE O B. FALSE An IRB may perform an expedited review of a protocol or informed consent form change if the change involves no more than minimal risk to study participants. O A. TRUE O B. FALSEWhich of the following is an important ethical considerations to keep in mind that can be compromised when using the RCT design? Group of answer choices: 1. Withholding treatment known to be effective 2. Deciding when to withdraw a patient from a study 3. Informing a patient of all of the potential side effects and toxic effects of a treatment 4. All of the above