Alcoac Study guides, Class notes & Summaries

ACRP Exam (Latest 2024/ 2025 Update) Questions and Verified Answers| 100% Correct| Grade A Q: To be a qualifying clinical trial, which three requirements must be met? a. the trial has therapeutic intent, has an investigational new drug number, and enrolls patients with diagnosed disease b. the trial has therapeutic intent, enrolls patients with diagnosed disease and evaluates an item/service that falls within a medicare benefit category c. the trial has therapeutic intent, has an investi...

ACRP CP Exam Questions and Answers Quality documentation practices ALCOAC stands for - Answer-Attributable, Legible, Contemporaneous, Original, Accurate, Complete After the New Drug Application is approved, the responsibility for reporting safety issues to the FDA rests with - Answer-The sponsor To whom may a sponsor transfer its responsibility for any or all of its clinical trial obligations? - Answer-Contract Research Organization Define role of CDRH and abbreviation - Answer-Center...

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...

ICH E6 (R2) correct answers ICH guideline that is known as GCP guideline 21 CFR 312.3 correct answers Individual who actually conducts a clinical investigation. In the event an investigation is conducted by a team of individuals, the investigator is the responsible leader of the team. Phase I correct answers Clinical trial phase that focuses on safety and human pharmacology in healthy volunteers. Principal Investigator correct answers Ultimately responsible for all aspects of the resear...

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...

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...

ACRP "CCRC" Exam Abbreviation List Questions and Answers 2023 ADR Adverse Drug Reaction AE Adverse Event ALCOAC Accurate, legible contemporaneous, original, attributable, and complete ALT Alanine Transaminase (liver enzyme) AST Aspartate Transaminase (liver enzyme) BID Twice a day BMI Body Mass Index BP Blood Pressure BUN Blood Urea Nitrogen (kidney function test) C Celsius CAPA Corrective and Preventive Action ...

Good Clinical Practice Quizzes- SET 1 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...

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...