ACRP CCRC EXAM 2024 WITH COMPLETE SOLUTIONS

ACRP CCRC EXAM 2024 WITH COMPLETE SOLUTIONS 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 Study - Answer ️️ -Subjects & Researchers are unaware Comparator - Answer ️️ -Item used as an active control references in a clinical trail Coordinating Committee - Answer ️️ -Group a sponsor comprises to coordinate multi-center trials Coordinating Investigator - Answer ️️ -An investigator who oversees multiple sites of a clinical trial (multicenter) IDMC - Answer ️️ -Independent Data Monitoring Committee, Data & Safety Monitoring Board (DSMB), Data Monitoring Committee: Oversee safety & progress; make recommendations to continue, modify or stop IEC - Answer ️️ -Independent Ethics Committee; group who oversees protection, rights, safety & well-being of human subjects Investigator's Brochure - Answer ️️ -Compilation of data on an investigational product used in human subjects Legally acceptable representative - Answer ️️ -person whom is lawfully able to consent on behalf of another SAE - Answer ️️ -Serious Adverse Event - Results in death, is life-threatening, requires long- term hospitalization, results in long term disability/hospitalization incapacitation or is a congenital birth defect Source data - Answer ️️ -original clinical information from source documents (medical record information) Vulnerable subjects - Answer ️️ -*Hierarchical structure employees *armed forces *detainees *incurable disease pts *homeless *poor *those in nursing home *minors *those unable to give consent ICH - Answer ️️ -International Conference on Harmonization Principles of ICH & GCP - Answer ️️ -*Protect research subjects *conduct research as it has been approved *research should be clear, organized & approved by an IRB/IEC IRB / IEC Responsibilities - Answer ️️ -*Oversee principles of ICH/GCP *Make sure the PI / Co-Is are qualified * Review studies at least once a year Requirements of an IRB - Answer ️️ -* at least 5 memb