BUNDLE - CCRP EXAMS

Nuremberg Code (1947) A research ethics code that arose in response to the Nazis' inhumane experimentation (nuremberg trials) - holocaust, racial hygiene / eugenics / master race. The Nuremberg Code - 10 points 1. voluntary 2. necessary for results 3. logical design and results 4. avoid...

CCRP Exam questions & answers How many days does a sponsor have to report an emergency use of an IP to the FDA? - ANSWER-5 working days How many members must sit on an IRB? - ANSWER-5 How long must an IRB retain records per 21 CFR 56? - ANSWER-3 years after completion of research What ...

Which of the following required elements should be included in a clinical trial protocol?

CCRP Practice Questions Prior to archiving a study, documentation of IP destruction at the site should be filed in the study files of the: - ANSWER-PI and Sponsor. In the case of an incapacitated subject, who should receive a copy of the signed and dated ICF? - ANSWER-The subject's legally ...

CCRP Exam questions & answers 2023 How many days does a sponsor have to report an emergency use of an IP to the FDA? - ANSWER-5 working days How many members must sit on an IRB? - ANSWER-5 How long must an IRB retain records per 21 CFR 56? - ANSWER-3 years after completion of research ...

Certified Clinical Research Professional (CCRP) Exam When isn't an IND application needed? - 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) - ANSWER-FDA Form 1571: -FDA Form 1571 ...

SOCRA CCRP Exam questions & answers 2023 April 30 1996 - ANSWER-ICH GCP Development Date Quality - ANSWER-ICH Q Efficacy - ANSWER-ICH E Safety - ANSWER-ICH S Multidisciplinary - ANSWER-ICH M guidance for industry, consolidated guideance - ANSWER-ICH E 6 Clinical Safety Data Ma...

CCRP AACVPR questions & answers 2023 What influences a persons metabolic rate? - ANSWER-Exercise, gender, genetics, age Which is the macronutrient that provides more than twice as many calories as the other two - ANSWER-Fat Foods that raise insulin levels have... - ANSWER-added sugar W...

SOCRA - CCRP (high level) 2023 Nuremberg Code (1947) - ANSWER-A research ethics code that arose in response to the Nazis' inhumane experimentation (nuremberg trials) - holocaust, racial hygiene / eugenics / master race. The Nuremberg Code - 10 points - ANSWER-1. voluntary 2. necessary for ...