Ccrp study guide - Study guides, Class notes & Summaries

Name the 4 Components of Physical Activity FITT and Progress is the ITP fifth Physical activity is defined as bodily movement that is produced by the contraction of skeletal muscle and that substantially increases energy expenditure. Exercise is defined as planned, structured, and repetitive bodily movement done specifically to improve one or more of the components of physical fitness. Name the 4 general categories of physical activity: 1. Occupational or work-related acti...

CCRP Patient Assessment Study Guide.

Certified Clinical Research Professional (CCRP) Exam Study Guide. When isn't an IND application needed? - correct answer IND Application is not needed if investigation does not support change in labeling What information must the general IND include? (21 CFR Part 312.23) - correct answer FDA Form 1571: -FDA Form 1571 cover sheet -Table of contents -Investigative plan -Investigator's brochure -Protocol -Chemistry/Manufacturing information -Pharmacology/toxicology -Previous human res...

SOCRA CCRP Nuremburg Code Certification Exam study guide Question with correct answers 2023/2024 Nuremburg Code - correct answer The first set of principles outlining professional ethics for clinical research. Nuremburg Code elements - correct answer 1. Voluntary informed consent 2. research benefits society 3. should be based on prior animal work 4. avoid suffering and injury 5. research where death and disabling injury is expected shouldn't be conducted 6. risks should be justified ...

How many days does a sponsor have to report an emergency use of an IP to the FDA? - 5 working days How many members must sit on an IRB? - 5 How long must an IRB retain records per 21 CFR 56? - 3 years after completion of research What are the criteria for IRB approval of research? (7) - 1. Risks to subjects are minimized 2. Risks are reasonable in relation to anticipated benefits 3. Selection of subjects is equitable 4. Informed consent will be sought from subjects or LARs 5. Informed ...

CCRP IRB, ICH and FDA Practice Guide Exam Question and answers 2023/2024 How many days does a sponsor have to report an emergency use of an IP to the FDA? - correct answer 5 working days How many members must sit on an IRB? - correct answer 5 How long must an IRB retain records per 21 CFR 56? - correct answer 3 years after completion of research What are the criteria for IRB approval of research? (7) - correct answer 1. Risks to subjects are minimized 2. Risks are reasonable in relati...

SOCRA CCRP EXAM ACTUAL EXAM 200 YEAR 2024/2025 / ACCURATE CURRENTLY TESTING EXAM VERSIONS WITH ACTUAL QUESTIONS AND DETAILED ANSWERS WITH A STUDY GUIDE / EXPORT VERIFIED FOR GURANTEED PASS / LATEST UPDATE

CCRP ICH-GCP and ICF Exam Practice Guide Questions and Verified Answers 2023/2024 Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the: - correct answer PI and Sponsor. In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? - correct answer The subject's legally acceptable representative Which of the following required elements should be included in a clinical trial protocol? - correct a...

CCRP Sponsor and Approved IDE Practice Exam Guide Questions and Answers 2023/2024 Sponsor - correct answer An entity that initiates a clinical investigation 3 primary responsibilities of an investigator - correct answer 1. Oversees the conduct of the clinical trial 2. Protects the rights, safety, and welfare of subjects 3. Control the use of investigational product FDA Form 1572 - correct answer Statement of Investigator Form - Signed Declaration from investigator that he/she will comply ...