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 once the protocol is finalised and submitted to the FDA.
<h3>
What is the FDA?</h3>
The Federal Food and Drugs Act, which was passed in 1906, led to the creation of the Food and Drug Administration (FDA). The organisation is divided into divisions, each of which is in charge of the majority of the organisation's responsibilities relating to food, medicines, cosmetics, animal food, nutritional supplements, medical devices, biological products, and blood products.
The FDA is renowned for its efforts to control the creation of new medications. All new pharmaceuticals must undergo clinical trials, according to regulations set down by the FDA. Before medicines may be offered to humans, pharmaceutical companies must put them through four stages of clinical testing.
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Answer:
Virus transmission is affected by a number of factors, including environmental determinants, host behavior, host defense mechanisms, and virus infectivity.
Explanation:
False, true I’m pretty sure
The Director of nursing would be most concerned with the safety standards established by the clinical laboratories’ improvement amendments or CLIA.
<h3>What is CLIA?</h3>
The Public Health Services Act was amended by the Clinical Laboratory Improvement Amendments of 1988 law, in which Congress altered the federal scheme for accreditation and oversight of clinical laboratory testing.
Federal standards that apply to all U.S. facilities or locations that test human specimens for health assessment or to diagnose, prevent, or treat disease are included in the Clinical Laboratory Improvement Amendments of 1988 (CLIA) rules.
Testing performed for forensic reasons (criminal investigations), testing carried out on human specimens for research or surveillance, and testing carried out on human specimens when patient-specific results are not reported are all exempt from the CLIA regulations.
These tests include employment-related drug testing by SAMSHA-certified laboratories.
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