Testing of your GCP knowledge: Admission test for the Accelerated Clinical Research program by CRA School | Apr 22, 2020 Welcome to your Test your knowedge of Good Clinical Practice (GCP) Your name Your email 1. What is the most important consideration during a clinical trial ?A. Adherence to protocolB. Safety and well-being of the trial subjectC. Proof of efficacyD. Sound statistical framework2. Who is responsible for trial conduct at the site ?A. The Clinical Research Associate (CRA)B. The SponsorC. The Principal Investigator (PI)D. The Clinical Research Coordinator3. What does ICH GCP defines as: “A document describing the objective(s), design, methodology, statistical considerations, & organization of a trial.”A. The Trial Master FileB. The Clinical Trial AgreementC. The Monitoring ReportD. The Protocol4. Prior to starting a clinical trial, the protocol must be approved by the:A. Regional Regulatory Authority (e.g. the FDA)B. The ethical review board (REB/IRB/IEC)C. SponsorD. Trial Steering Committee5. What must be obtained from all potential trial subjects before they take part in the trial ?A. Non-Disclosure AgreementB. Legal waiver, absolving the sponsor from legal consequencesC. Physical examD. Signed Informed Consent6. What is the minimal frequency for continuing review conduct by the Institutional Review Board / Independent Ethics Committee (IRB/IEC) regardless of the degree of risk to human subjects ?A. Once per monthB. Every 6 monthsC. Once per yearD. No minimum is stated in ICH GCP7. What is the minimum number of members on an IRB/IEC ?A. No minimum number is statedB. 4 membersC. 5 membersD. 6 members8. There must be at least one IRB/IEC member with the following characteristic:A. Representative of the SponsorB. Layperson (non-scientific)C. A patient with the target disease/health concern of interestD. Someone with a formal training in ethics9. How long must the IRB/IEC maintain their records securely ?A. For 2 years following the start of the trialB. For 2 years following completion of the trialC. For 3 years following the start of the trialD. For 3 years following the completion of the trial10. What is the general purpose of the Investigator’s Brochure ?A. It is a comprehensive description of all clinical & non-clinical data known about the investigational product.B. It describes the procedures and goals of the proposed clinical trialC. It is a critical analysis by the Principal Investigator concerning the proposed trialD. It is the legal agreement between the Principal Investigator and the sponsor11. What word is missing about Informed Consent: “Neither the investigator, nor the trial staff, should ______________ or unduly influence a subject to participate or to continue to participate in a trial.”A. ManipulateB. CoerceC. ConvinceD. Compensate12. What does GCP say about CRF corrections: “Any change or correction to a CRF should be dated, initialled, and explained (if necessary) and should not _________________”A. Provide a data trailB. Obscure the original entryC. Leave visible the original entryD. Contradict the original entry13. What WORD IS MISSING? “All serious adverse events (SAEs) should be reported immediately to the sponsor except for _______________”A. Those that the investigator deems unimportantB. Those identified in the protocol as not requiring reportingC. Those that are previously known to occurD. Those that spontaneously resolve within 24 hours14. The investigator must conduct the trial in compliance with 3 requirements. Which is not one of them ?A. GCP GuidelinesB. Applicable regulatory requirementsC. Approved protocolD. FDA Certification15. Which of the following is not one of the 3 main goals of clinical trial monitoring ?A. Ensuring protection of the rights and well-being of the trial subjectB. Ensuring that data from the trial is in line with the sponsor’s goalsC. Ensuring that data is accurate, complete and verifiableD. Ensuring that trial conduct is in compliance with GCP, the protocol and regulations16. What does GCP say about the required extent of monitoring activities ?A. They should be adequateB. They should occur at least every monthC. They should occur at least every 2 monthsD. No specific mention is made of this in GCPOption 417. What essential document does the following refer to ? “________ is a compilation of the clinical and nonclinical data on the investigational product(s) that are relevant to the study of the product(s) in human subjects. Its purpose is to provide the investigators and others involved in the trial with the information to facilitate their understanding of the rationale for, and their compliance with, many key features of the protocol, such as the dose, dose frequency/interval, methods of administration: and safety monitoring procedures.”A. The Clinical Trial ProtocolB. The Trial Master File (TMF)C. The Clinical Trial Agreement (CTA)D. The Investigator’s Brochure (IB)18. What is described in the following GCP definition: “A systematic and independent examination of trial related activities and documents to determine whether the evaluated trial related activities were conducted, and the data were recorded, analyzed and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), Good Clinical Practice (GCP), and the applicable regulatory requirement(s).”A. An Internal AuditB. For-Cause InspectionC. Routine InspectionD. Site Regulatory Analysis19. What is described by the following GCP definition: “An individual or juridical or other body authorized under applicable law to consent, on behalf of a prospective subject, to the subject’s participation in the clinical trial”.A. Trial Subject RepresentativeB. Legal RepresentativeC. Legally Acceptable RepresentativeD. Legally Commissioned Representative20. What does ICH GCP describe as: “The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled.”A. Quality ControlB. Quality AssuranceC. AuditsD. Inspections21. What documents the existence of the subject and substantiates integrity of trial data collected ?A. Case Report FormsB. Monitoring ReportsC. Informed Consent FormsD. Source Documents22. What document, created in 1964, provides the foundation for ethical considerations in clinical research ?A. Nuremberg CodeB. Helsinki DeclarationC. Belmont ReportD. WHO Guidelines23. Which of the following statements best describes an Adverse Event ?A. Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.B. Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which has a definite causal relationship with this treatment.C. Any untoward physical change in a patient or clinical investigation subject administered a pharmaceutical product which is strongly suspected of having a causal relationship with this treatment.Option 3D. Any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which is suspected of interacting with another drug.24. What term describes “Documentation that allows reconstruction of the course of events.”A. Source DocumentsB. Case Report FormsC. Monitoring ReportsD. Audit Trail25. What is a term for “An investigational or marketed product (i.e., active control), or placebo, used as a reference in a clinical trial.”A. Contrast ProductB. ComparatorC. Baseline ProductD. Reference Product4 out of 3Time is Up!