ACRP CCRC (Actual) Exam Solved 100% Correct

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 members * one non-scientific member * one non-institute member What needs reported to the IRB? - ANSWER-*Changes / deviations from protocol due to unforeseen hazard * changes to subject risk * adverse events * new info that may impact subject safety Payment to subjects must be.... - ANSWER-prorated & not contingent on subject completing study Investigator Responsibilities - ANSWER-*Maintain delegation long *Ensure staff are trained/informed about the protocol (give delegated tasks) * Ascertain reason study participant withdraws consent while respecting their privacy & rights * Adhere to approved protocol *Document & explain any deviations from approved protocol * Process protocol amendments according to GCP *Manage proper storage & care for trial devices/drugs. (PI can delegate this task to trained professional - PharmD, etc) Protocol amendments should be submitted to - ANSWER-1. IRB 2. Sponsor 3. Regulatory Authority