Gcp certification exam - Study guides, Class notes & Summaries
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ACRP CCRA/CCRC Certification Exam prep Questions and Answers 2023
- Exam (elaborations) • 39 pages • 2023
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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...
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SOCRA CCRP FINAL EXAM STUDY QUESTIONS & ANSWERS.
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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...
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GLP Certification Exam 2023
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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...
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SOCRA CCRP Exam Questions with Correct Answers
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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...
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CLG 0010 DOD GOV. COM. PUR. CARD OVERVIEW EXAM | Questions with 100% Correct Answers | Latest Update | Verified
- Exam (elaborations) • 4 pages • 2023
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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...
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ACRP-CP Certification Exam 2024/25 EDITION GUARANTEED GRADE A+
- Exam (elaborations) • 21 pages • 2024
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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...
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ACRP CCRC Final Certification Exam Review Practice Questions and Answers 2023/2024
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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 ...
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ACRP Certification Exam Abbreviation List 100% Correct.
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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...
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ACRP Practice Exam 2022 Questions and Answers
- Exam (elaborations) • 9 pages • 2022
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[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...
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Test for SOCRA CCRP EXAM (Mega certification 2024) Q&A
- Exam (elaborations) • 106 pages • 2024
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Test for SOCRA CCRP EXAM (Mega 
certification 2024) Q&A 
5 - CORRECT ANSWER-The minimum number of IRB members 
Subjects cannot be enrolled until IRB/IEC approval has been obtained - CORRECT 
ANSWER-In a non-emergency situation, under which of the following conditions, if any, 
may subjects be enrolled into a study prior to IRB/IEC approval? 
The Sponsor - CORRECT ANSWER-The responsibility for ensuring that the investigator 
understands a clinical trial lies with: 
A subject has been enrolled...
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