Socra CCRP Exam Bundle Questions and Answers 100 % VERIFIED!!

Declaration of Helsinki (1964, 1975) - ANSWER -Set of ethical principles regarding human experimentation developed for the medical community by the World Medical Association (WMA) Good Clinical Practice (GCP) - ANSWER -ICH-GCP and ISO-GCP (medical device) enforces guidelines on ethical aspects of...

Nuremburg Code elements - 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 7. proper preparation...

Closed System - ANSWER -An environment in which system access is controlled by persons who are responsible for the content of electronic records that are on the system. (21 CFR, Sec. 11.3) Digital Signature - ANSWER -An electronic signature based upon cryptographic methods of originator authentic...

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 Management Definitions and Standards - ANSWER -ICH E2A Safety pharmacology studies for huma...

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 Investigators What are the three main basic ethical principles ...