ICH E6 has broader requirements than FDA or HHS concerning confidentiality of medical records and access by third parties. If investigators are complying with ICH E6 guideline, they must:
answer
Clearly disclose to subjects in the informed consent form that the monitor, auditor, IRB/IEC, and the regulatory authorities may have access to the subject's medical records Explanation: The ICH E6 guideline has broader requirements concerning confidentiality of medical records and access by third parties than the FDA or HHS. Investigators must take steps to ensure that all medical records are kept confidential and that only authorized personnel have access to them. They must also ensure that any third party who needs access to the records (such as a sponsor or regulatory agency) has a valid reason for doing so and that their access is limited to only the information that they need.
question
Regarding subject receipt of a signed and dated copy of the consent forms, which is true about FDA regulations?
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The FDA regulations allow subjects or the legally acceptable representatives (LARs) to receive either a signed or unsigned copy Explanation: FDA regulations do not require that the subject receive a signed and dated copy of the consent forms, but it is generally considered good practice to do so.
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What is the status of ICH in U.S.?
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It is a FDA guidance. Explanation: The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a tripartite organisation that includes representatives from the regulatory authorities of Europe, Japan, and the United States. ICH harmonises (brings into agreement) the technical requirements for the registration of pharmaceuticals for human use. This includes standards for safety, efficacy, and quality. In the US, the Food and Drug Administration (FDA) is a member of ICH.
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In terms of explaining the probability of assignment to trial arms in consent forms, which is true?
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ICH notes that it should be included, but does not specify how the information should be presented. Explanation: There is no definitive answer to this question as it depends on a number of factors, including the specific design of the clinical trial, the number of arms in the trial, and the number of participants enrolled. However, in general, it is typically true that the probability of being assigned to a particular trial arm is equal for all participants. This means that, if a trial has two arms, each participant has a 50% chance of being assigned to either arm. If a trial has three arms, each participant has a 33% chance of being assigned to each arm, and so on.
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The new ICH E6 integrated addendum (R2) requires sponsors to implement systems to manage quality throughout all stages of the trial process. The system should use a risk-based approach including which of the following?
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Identification of study risks to determine which may safely be omitted from continual monitoring Explanation: The new ICH E6 integrated addendum (R2) requires sponsors to implement systems to manage quality throughout all stages of the trial process. The system should use a risk-based approach including the following:1. Identification of risks throughout the trial process2. Assessment of the impact of risks on the quality of the trial data3. Implementation of mitigation plans to reduce the impact of risks on the quality of the trial data4. Monitoring of the effectiveness of mitigation plans5. Reporting of risks and mitigation plans to the trial steering committee and other relevant stakeholders6. Regular review of the risk management system to ensure its effectiveness
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