Legible contemporaneous - Study guides, Class notes & Summaries

RAC Glossary 2023 Review Update 21st Century Act - ANS-Amends FD&C Act and PHS Act to include provisions for: patient focused drug development, advancing new drug therapies, modern trial design and evidence development, patient access to therapies and information, antimicrobial innovation and stewardship, medical device innovations, improving FDA expertise and outreach, medical countermeasures innovation, vaccine access, certainty and innovation. 30-Day hold - ANS-Time period between f...

ACRP CP Exam Questions and Answers 100% Pass Phase I -Answer-The clinical trial phase that focuses on safety and human pharmacology in healthy volunteers Who is ultimately responsible for all aspects of the research conducted at a site? - Answer-Principal investigator Define GCP -Answer-An international quality standard that is provided by ICH E6(R2) describing safety, accuracy of trials and credibility of data What event resulted in the Nuremburg Cod of 1949 -Answer-Nazi Medical Experime...

ACRP exam ALCOAC - correct answer Accurate, legible, contemporaneous, original, attributable, complete Good Clinical Practice (GCP) - correct answer A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected. ICH - correct answer international conference...

Maintaining your Certificate Every two years (biennially) available 60-90 days prior to your expiration date Expired certificate You cannot practice as a respiratory therapist until you receive your renewal approval form from TMB Inactive Status applied through the advisory board - must renew inactive certificate each year for up to five years - if not active after 5years certificate will be cancelled. Return to active by applying to the board, paying app fee, verification form...

Maintaining your Certificate Every two years (biennially) available 60-90 days prior to your expiration date Expired certificate You cannot practice as a respiratory therapist until you receive your renewal approval form from TMB Inactive Status applied through the advisory board - must renew inactive certificate each year for up to five years - if not active after 5years certificate will be cancelled. Return to active by applying to the board, paying app fee, verification form...

Good Clinical Practice (GCP)GCP Principle 1 - correct answer 'The rights, safety and wellbeing of the trial subjects shall prevail over the interests of science and society.' GCP Principle 2 (staff) - correct answer 'Each individual involved in conducting a trial shall be qualified by education, training and experience to perform his tasks.' GCP Principle 3 - correct answer 'Clinical trials shall be scientifically sound and guided by ethical principles.' GCP Principle 4 - correct ...

ADR - Answer- Adverse Drug Reaction AE - Answer- Adverse Event ALCOAC - Answer- Accurate, Legible, Contemporaneous, Original, Attributable, and Complete ALT - Answer- Alanine Transaminase (liver enzyme) AST - Answer- Aspartate Transaminase (liver enzyme) BID - Answer- Twice a day BMI - Answer- Body Mass Index BP - Answer- Blood Pressure BUN - Answer- Blood Urea Nitrogen (kidney function test) C - Answer- Celsius CAPA - Answer- Corrective and Preventive Action CIO...

ICH Good Clinical PracticeWhat is GCP? - correct answer You're probably wonder what Good Clinical Practice, or GCP, is exactly! In 1990, a conference called the International Conference on Harmonization took place and GCP guidelines were created. According to this document, GCP is: "A standard for the design, conduct, performance, monitoring, auditing, recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, ...

SAE - Serious Adverse Event: - results in death - is life threatening (patient was at risk of death at time of the event) - results in persistent or significant disability - congenital anomaly/birth defect Short Form - A document that states that the elements of informed consent have been presented orally to and understood by the participant or the participant's LAR. 4 components of short form - 1. A short form consent document 2. And oral presentation of the required elemen...

PHC 216 Midterm Exam 2023 QUESTIONS & ANSWERS 100% CORRECT   PHC 216 Midterm Exam 2023 Why the patients Information must be properly protected? a. To prevent it from the patient’s reach b. To prevent malicious, thoughtless or inadvertent breaches of confidentiality c. To prevent the patients from the necessary treatment provided in the clinic d. To prevent the patient from getting benefit from the healthcare team 2. Who is responsible for deciding what treatment to ...