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International Council for Harmonisation ICH E6 Latest Exam With Questions And Accurate Answers
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International Council for Harmonisation ICH E6 Latest ExamWith Questions And Accurate Answers
Goals of ICH - Answer Standardisation of technical requirements for the authorisation to
market new drugs, so that applications for marketing to the various regulatory agencies
around the world can be made without redundant testing
ICH E6 has become - Answer The international standard for the design, conduct,
monitoring, and reporting of clinical research of investigational drugs
Good Clinical Practice (GCP) - Response Provides assurance to protect the rights,
safety, and well-being of study subjects involved in a clinical trial and to ensure quality
and integrity of the resulting data.
Legal Representative - Response An individual, or judicial or other body, authorized
under applicable law to consent on behalf of a prospective subject to the subject's
participation in the research
Protocol Deviation (or Violation) an unplanned excursion from the requirements of the
protocol that is not implemented or intended as a systematic change.
CH membership includes which five (5) regulators? Response Health Canada
European Commission EU
Ministry of Health Labor & Welfare
Pharmaceuticals &Medical device agency (PDMA from Japan)
Swissmedic
FDA
When does the ICH E6 guideline apply? - Answer several countries adopted it as law. In
,the U.S., however, the FDA adopted the ICH E6 only as guidance
FDA adopted the ICH E6 only as guidance (HHS and FDA 1997) True or False - Answer
True: ICH guidelines do not have the force of law in the U.S. and are not regulations
Advantages of compliance with ICH E6 - Answer Studies done to meet the regulatory
requirements of the drug approval processes for all these countries.
(4) main categories of ICH guidelines - Answer Quality, Safety, Efficacy,
Multidisciplinary
"Efficacy" category - Answer conduct of clinical research in support of marketing
applications for drugs.
ICH E6-Answer provides an integrated standard for the design, conduct, recording, and
reporting of research involving human subjects.
2 main objectives of ICH E6 are to ensure that: - Answer 1)The rights, well-being, and
confidentiality of trial subjects are protected
2)Trial data are credible
principles of ICH GCP - Answer 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).
The next principles of ICH GCP -Answer Anticipated benefits and risks should be
balanced and should be favourably weighed against the foreseeable risks and
inconveniences before a trial is initiated. A trial should not be started, nor continued, if
there are unreasonable risks to participants.
The general responsibilities of an investigator include qualifications for providing
answers, resources, medical care for research subjects, interaction with the IRB/IEC,
, compliance with protocol, investigational product accountability, informed consent of
trial subjects, recordkeeping, and reporting. It is expected that every investigator
involved in clinical trials under ICH will follow these guidelines.
Among these, the sponsor responsibilities include quality management of the answer,
assurance and control of quality, trial design, trial management, investigator selection,
compensation to subjects and investigators, confirmation that the review by IRB/IEC has
been performed, supplies and handling of the investigational product, adverse drug
reaction reporting, monitoring, auditing, among others.
Sponsor can delegate all or some of their activities and responsibilities to a
CRO-Answer: The sponsor must have to ensure the oversight of CRO and put in writing
what responsibilities are transferred.
ICH E2A, Clinical Safety Data Management: Definitions and Standards for Expedited
Reporting. Response should address expectations regarding safety monitoring in
clinical trials and focus on the sponsor's role and responsibilities for reporting AEs.
ICH E8, Guidance on General Considerations for Clinical Trials Response should outline
drug development and ICH requirements to determine safety and efficacy of an
investigational agent.
What are the differences between ICH E6 guideline FDA regulations and HHS
regulations? - Answer ICH E6 guideline generally agrees with the FDA regulations for
IRBs/IECs, sponsors, and investigators
ICH guideline has requirements that go beyond either FDA (or HHS) requirements -
Answer ICH E6 is not codified in U.S. federal regulation and does not carry the same
legally binding weight of the code of federal regulations.
In the U.S., following the ICH E6 guideline is voluntary on the part of investigators in that
it is NOT a federal rule. - Answer research institutions where clinical trials of drugs are
carried out, pharmaceutical sponsors often require that the requirements in the ICH be
followed.
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