Acrp ccrc study guide - Study guides, Class notes & Summaries

ACRP CCRC Study Guide Questions and Answers 2023 What is ICH E2A? Clinical Safety Data Management -Definitions and Standards for Expedited Reporting -This document gives standard definitions and terminology for key aspects of clinical safety reporting. -It also gives guidance on mechanisms for handling expedited (rapid) reporting of adverse drug reactions in the investigational phase of drug development. ICH E2A: An adverse event is defined as one which a) Results in hospi...

ACRP CCRC Study Guide

What is ICH E2A? - Answer- Clinical Safety Data Management -Definitions and Standards for Expedited Reporting -This document gives standard definitions and terminology for key aspects of clinical safety reporting. -It also gives guidance on mechanisms for handling expedited (rapid) reporting of adverse drug reactions in the investigational phase of drug development. ICH E2A: An adverse event is defined as one which a) Results in hospitalization b) Causes a disability c) Is not necessa...

ACRP CCRC Study Guide

ACRP CCRC Competency study guide Exam test questions with approved Answers 2024/2025 According to the ICH-E2A, what is the initial reporting timeline required by the sponsor for all other serious, unexpected ADR's? - correct answer ≤ 15 calendar days. "As soon as possible, but no later than 15 calendar days after first knowledge by the sponsor." A subject in a Phase I oncology trial experiences nausea with vomiting after IP infusion which results in an inpatient hospitaliza...

ADR - Answer- Adverse Drug Reaction Audit - Answer- Reviews how the research was conducted; takes into account SOPs, IRB requirements & GCP (ensures compliance) Audit Certificate - Answer- Confirmation audit took place Audit Report - Answer- Written Evaluation - not regularly made available to regulatory body; only when serious evidence exists concerning non-compliance Audit Trail - Answer- Documentation of audit events Single Blind Study - Answer- Subjects Unaware Double Blind...

ACRP Key Terms for CCRC exam, CCRC Exam, ACRP CCRC EXAM PREP, CCRC Exam Prep, ACRP CCRC, *CCRC Study Set 3.4.21 Questions and Answers 2023 Human Pharmacology Study -Assess Tolerance -Define/Describe pharmacokinetics and pharmacodynamics -explore drug metabolism and drug interactions -estimate activity Human Pharmacology Study Examples: -dose tolerance studies -single and multiple does pharmacokinetics and pharmacodynamic studies -drug interaction studies Therapeutic Explor...