SOCRA 2023 EXAM FULL PACKAGE WITH 100% ACCURATE QUESTIONS AND ANSWERS!!

Biometrics - ANSWER A method of verifying an individual's identity based on measurement of the individual's physical features or repeatable actions where those features and or actions are both unique to that individual and measurable. (21 CFR, Sec. 11.3) Closed System - ANSWER An environment in...

Does the FDA consider electronic signatures to be as trustworthy and reliable as handwritten paper signatures? - ANSWER Yes (although permission to use such e-sigs has to be approved by the FDA) Does the FDA consider electronic records that meet requirements to be equivalent to handwritten record...

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 Management Definitions and Standards - ANSWER IC...

Investigator should (qualifications/agreements) - ANSWER Be qualified by training/education and expertise Be familiar with the product investigational Be aware and comply with GCP and regulatory requirements Permit auditing/monitoring Delegate authority and maintain a log Be responsible for t...

Laws - ANSWER passed by national legislative bodies; establish authority of national regulatory body Regulations - ANSWER Passed by regulatory authorities; controls how medical products are investigated and approved; have effect of law guidance - ANSWER "current thinking" of regulatory bodie...