Which of the following statements about the Good Clinical Practice Guideline (ICH/GCP) are correct?
A. The first version of the ICH E6 Good Clinical Practice (GCP) Guideline was finalized in 1996 describing the responsibilities and expectations of all participants in the conduct of clinical trials, including investigators, monitors, sponsors, & IRBs. GCP covers aspects of monitoring, reporting, & archiving of clinical trials & incorporating addenda on the Essential Documents & on the Investigator's Brochure.
B. This harmonized guideline has been amended in 2016 with an integrated Addendum to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, & reporting while continuing to ensure human subject protection & reliability of trial results.
C. Standards regarding electronic records & essential documents intended to increase clinical trial quality & efficiency have also been updated in 2016.
D. This ICH GCP Guideline Integrated Addendum provides a unified standard for the European Union, Japan, the US, Canada, & Switzerland to facilitate the mutual acceptance of data from clinical trials by the regulatory authorities in these jurisdictions.
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The 10 principles of good clinical practice (GCP) adopted by International Conference Harmonization (ICH) in 2016 are:
A. 1. Clinical trials should be conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki, and that are consistent with GCP and the applicable regulatory requirement(s).2. Before a trial is initiated, foreseeable risks and inconveniences should be weighed against the anticipated benefit for the individual trial subject and society. A trial should be initiated and continued only if the anticipated benefits justify the risks.
B. 3. The rights, safety, and well-being of the trial subjects are the most important considerations and should prevail over interests of science and society.4. The available nonclinical and clinical information on an investigational product should be adequate to support the proposed clinical trial.5. Clinical trials should be scientifically sound, and described in a clear, detailed protocol.
C. 6. A trial should be conducted in compliance with the protocol that has received prior institutional review board (IRB)/independent ethics committee (IEC) approval/favourable opinion.7. The medical care given to, and medical decisions made on behalf of, subjects should always be the responsibility of a qualified physician or, when appropriate, of a qualified dentist.8. Each individual involved in conducting a trial should be qualified by education, training, and experience to perform his or her respective task(s).
D. 9. Freely given informed consent should be obtained from every subject prior to clinical trial participation.10. All clinical trial information should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification.
Individualswhosewillingnesstovolunteerinaclinicaltrialmaybeundulyinfluencedbytheexpectation,whetherjustifiedornot,ofbenefitsassociatedwithparticipation,orofaretaliatoryresponsefromseniormembersofahierarchyincaseofrefusaltoparticipate.Examplesaremembersofagroupwithahierarchicalstructure,suchasmedical,pharmacy,dental,andnursingstudents,subordinatehospitalandlaboratorypersonnel,employeesofthepharmaceuticalindustry,membersofthearmedforces,andpersonskeptindetention.Othervulnerablesubjectsinclude______________________________________________.
A. patientswithincurablediseases
B. personsinnursinghomes
C. unemployedorimpoverishedpersons
D. patientsinemergencysituations
Individualswhosewillingnesstovolunteerinaclinicaltrialmaybeundulyinfluencedbytheexpectation,whetherjustifiedornot,ofbenefitsassociatedwithparticipation,orofaretaliatoryresponsefromseniormembersofahierarchyincaseofrefusaltoparticipate.Examplesaremembersofagroupwithahierarchicalstructure,suchasmedical,pharmacy,dental,andnursingstudents,subordinatehospitalandlaboratorypersonnel,employeesofthepharmaceuticalindustry,membersofthearmedforces,andpersonskeptindetention.Othervulnerablesubjectsinclude______________________________________________.
A. ethnic minority groups
B. homeless persons, nomads, refugees
C. minors
D. those incapable of giving consent
Which of the following statements aboutvulnerable subjects are correct?
A. Individuals whose willingness to volunteer in a clinical trial may be unduly influenced by the expectation, whether justified or not, of benefits associated with participation, or of a retaliatory response from senior members of a hierarchy in case of refusal to participate.
B. Examples are members of a group with a hierarchical structure, such as medical, pharmacy, dental, and nursing students, subordinate hospital and laboratory personnel, employees of the pharmaceutical industry, members of the armed forces, and persons kept in detention.
C. Other vulnerable subjects include patients with incurable diseases, persons in nursing homes, unemployed or impoverished persons, patients in emergency situations, ethnic minority groups, homeless persons.
D. Other vulnerable subjects include nomads, refugees, minors, and those incapable of giving consent.
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