Gcp certification exam - Study guides, Class notes & Summaries

ACRP CCRA/CCRC Certification Exam prep Questions and Answers 2023 Adverse Event (AE)/Adverse Experience Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. Adverse Drug Reaction (ADR) All noxious and unintended response to a medicinal product related to any dose. Unexpected Adverse Drug Reaction An adverse reaction, the nature o...

SOCRA CCRP FINAL EXAM STUDY QUESTIONS & ANSWERS. Contract Research Organization - correct answer A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. When a short form is used for informed consent the witness must sign the short form or the summary? - correct answer False-they must sign both What is FDA form 3454 - correct answer Certification Financial Interests and Arrangements...

GLP Certification Exam 2023 IND - ANS-Investigational new drug( application) NDA - ANS-new drug application Motto - ANS-if it isn't written down it never happened t What triggered GLP regulations - ANS-IBT industrial bio-test lab. failed audit; sponsor failure to validate data/data not critically reviewed/ non-adherence to protocols/inaccurate analysis/untrained personnel use FFDCA - ANS-federal food drug and cosmetic act CFR - ANS-code of federal regulation -anything under FDA alway...

SOCRA CCRP Exam Questions with Correct Answers Contract Research Organization - Answer-A person or an organization (commercial, academic, or other) contracted by the sponsor to perform one or more of a sponsor's trial-related duties and functions. When a short form is used for informed consent the witness must sign the short form or the summary? - Answer-False-they must sign both What is FDA form 3454 - Answer-Certification Financial Interests and Arrangements of Clinical Investigato...

CLG 0010 DOD GOV. COM. PUR. CARD OVERVIEW EXAM | Questions with 100% Correct Answers | Latest Update | Verified whose responsibility is it to comply with Government agency standards of conduct? (select the three that apply) - 1. approving/billing officer 2. supervisor 3. agency/organization program coordinator If commercial, door-to-door shipping is not available for GPC purchase to be shipped overseas, the card holder must - Coordinate with a transportation service support office bef...

ACRP-CP Certification Exam 2024/25 EDITION GUARANTEED GRADE A+ What would be the first priority for an investigator when a subject wishes to withdraw prematurely from the trial? Try to obtain the subject's reason for withdrawal. CRO recently switched from paper CRF to an EDC system. The EDC system must conform to the established requirements for Validation Accuracy Reliability Completeness Part of a sponsor's responsibility pertaining to electronic trial data handling is to maintain a...

ACRP CCRC Final Certification Exam Review Practice Questions and Answers 2023/2024 What are expected or possible consequences of over-estimation of recruitment potential? - correct answer - The trial will overrun its projected timeline - The recruitment period will be prolonged and more sites may be needed - The study will not have sufficient data within the required timeframe and will be stopped because of lack of budget What should be the first consideration when conducting a clinical ...

ACRP Certification Exam Abbreviation List 100% Correct. ADR Adverse Drug Reaction AE Adverse Event ALT Alanine transaminase AST Aspartate transaminase b.i.d. twice a day BP Blood pressure BUN Blood Urea Nitrogen C Celsius CIOMS Council for International Organizations of Medical Sciences CK Creatine Kinase CRA Clinical Research Associate CRC Clinical Research Coordinator CRF Case Report Form CRO Contract Research Organization CV Curriculum Vitae DCF Data Clarification Fo...

[COMPANY NAME] [Company address] ACRP PRACTICE EXAM 2022 QUESTIONS AND ANSWERS A subject is issued 120 tablets and is instructed to take 2 tablets 4 times a day. He returns 88 tablets on the morning of day 9 fasting for laboratory tests. What percent compliant is he? - ANSWER 50% To be eligible for a trial, the subjects must have liver function tests no greater than two times the upper limit normal and rental function tests no greater than three times the upper limit normal. All of t...

CCRC Module 2: Overview of ACRP Certification Exam References 100%SOLUTION Regulations - ANSWER - are issued by regulatory authorities such as the FDA, or European Medicines Agency [EMA] -applicable only in the country or countries within the jurisdiction of these authorities (e.g. FDA = USA, EMA = Europe) The 3 primary ICH regions - ANSWER Japan, USA, EU Why did ICH guidelines develop? - ANSWER To prevent duplication of efforts in 3 countries [Japan, US, EU] when industry and r...