Clinical Research Associate (CRA) Training: Questions and Solutions, Exams of Nursing

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CRA Training QUESTIONS WITH

COMPLETE SOLUTIONS

CRA correct answer: Clinical Research Associate

• a healthcare professional who monitors clinical trails Permanent CRA correct answer: - true career progression
• sign-on bonus
• salaried with comprehensive benefits ICH GCP correct answer: International Conference on Harmonization Good Clinical Practices
• guidelines for all trails Contract CRA correct answer: - no sign-on bonus
• higher hourly rate
• 1099 employee
• no benefits ACRP correct answer: Association of Clinical Research Professionals do CRA certification CROs correct answer: Contract Research Organizations
• organizations hired by pharm companies/sponsors to complete some or all the aspects of a clinical trial

Sponsor correct answer: Drug developer aka Pharm company

• ultimately responsible for the conduct of the clinical trail
• submit the IND application to the FDA before the trial begins IND correct answer: Investigational New Drug FDA correct answer: Food and Drug Administration
• the Regulatory Authority Protocol correct answer: - the blueprint of a clinical trial
• Clinical study plans Phase I correct answer: first introduction into humans for safety and dosage 20-30 HEALTHY individuals Phase II correct answer: for efficacy and side effects few hundred with the disease Phase III correct answer: for safety, efficacy and side effects basically phase II on a longer and larger scale several hundred with the disease Phase IV correct answer: post market surveillance several thousand with disease PI correct answer: Investigator; Principal Investigator

• assumes full responsibility of proper conduct
• the MD resp for the conduct of a trial at the investigational site NDA correct answer: New Drug Application submission
• formal proposal from Sponsor to FDA for approval of sale and marketing of a new drug in the US
• submitted after Phase III NDS correct answer: New Drug Submission Canadian equivalent of NDA MAA correct answer: Marketing Authorization Application European equivalent of NDA Investigational Site correct answer: physical location of the clinical trial ex: hospitals, academic institution, doctor's office etc. Study Coordinator correct answer: manages all trial related activities at the investigational site
• CRA's most contact IRB correct answer: Institutional Review Board
• aka Ethics Committee
• committee established to review and approve clinical research in humans at the investigational site
• site specific

QV correct answer: Qualification Visit

• or Pre-Study Visit (PSV)
• to review
  • the adequacy of the site
  • training and experience of the staff
  • access to proper patient population
  • site's interest in the study Inclusion correct answer: requirements a patient needs to have to participate in a trial Exclusion correct answer: characteristics that exclude a certain subjects ICF correct answer: Informed Consent Procedures
• subject's voluntary confirmation of his or her willingness to participate in a trial after being informed of all the aspects of the trial
• typically site specific SDV correct answer: Source Data Verification
• original source data requirements IP correct answer: Investigational Product tested drug

Investigators Brochure correct answer: comprehensive document that summarizes all the info about the drug Monitoring Plan correct answer: CRA's blueprint for monitoring SIV correct answer: Site Initiation Visit MV correct answer: Monitoring Visit TV correct answer: Termination visit Study start up correct answer: the activation process of a site FDA 1572 correct answer: - a binding agreement between the FDA and the PI stating that the investigator will follow the "Rules"

• a statement of investigation