For D

Which of the following best defines an Adverse Event (AE) as per the Malaysian Guideline for Good Clinical Practice (4th Edition)?

• Any harmful and unintended response to a medicinal product that is suspected to be causally related to any dose during clinical use.

• Any unfavorable and unintended symptom, sign, or disease that occurs after administration of a pharmaceutical product, irrespective of whether it is causally related to the treatment.

• Any event resulting in hospitalization or death following administration of a pharmaceutical product, whether or not related to the product.

• Any deviation from the expected therapeutic response following the use of an investigational product that is judged to be caused by the drug under investigation.

Which of the following best defines an Adverse Drug Reaction (ADR) according to the Malaysian GCP (4th Edition)?

• A noxious and unintended response to a drug that occurs at therapeutic doses and for which a causal relationship is at least a reasonable possibility.

• Any symptom or sign that emerges following drug administration during a clinical trial, even if unrelated to the study drug.

• Any untoward medical occurrence after the administration of a drug, regardless of dose or whether a causal relationship can be established.

• An unexpected medical condition observed during the course of drug treatment that does not necessarily relate to the pharmacological activity of the drug.

Which of the following best describes the validation of a computerized system in the context of GCP?

• A process to confirm the computer software performs within user expectations and complies with standard programming protocols throughout its operational lifespan.

• The act of installing clinical trial software and ensuring it is password-protected, secure, and backed up on a weekly basis.

• A documented process that ensures the computerized system meets its specified requirements consistently from design to decommissioning, considering intended use and impact on subject protection and trial data integrity.

• An assessment conducted by the sponsor’s IT department to determine the technical suitability of a system for data storage and sharing purposes only.

According to the Malaysian GCP, which of the following best defines a vulnerable subject?

• Any individual whose ability to consent is compromised due to a physical disability or chronic illness.

• Anyone belonging to a minority group or lower socioeconomic class, whose trial participation requires additional monitoring.

• Individuals who may feel pressured to participate in a trial due to hierarchical relationships or expectations of benefit, whether justified or not.

• A trial participant who is unable to comply with visit schedules or understand clinical trial procedures due to educational limitations.

Which of the following best describes a core responsibility of an Institutional Review Board (IRB) according to the Malaysian GCP guideline?

• To monitor trial recruitment progress and verify the accuracy of case report forms submitted by investigators.

• To provide legal representation for subjects participating in clinical trials and ensure compliance with local contract law.

• To coordinate data analysis activities across multiple trial sites to ensure consistency in reporting trial outcomes.

• To safeguard the rights, safety, and well-being of human subjects by reviewing and approving the scientific and ethical aspects of proposed clinical trials.

Which of the following is true regarding IRB composition as per the Malaysian GCP?

• The IRB must consist solely of healthcare professionals who are experts in the study’s therapeutic area.

• IRB members must have at least 10 years of clinical research experience to ensure qualified review of protocols.

• The IRB must include a legal advisor and a representative from the Drug Control Authority in all reviews of industry-sponsored trials.

• At least one IRB member must be independent of the institution or trial site, and the IRB must include both scientific and non-scientific members.

Which of the following best reflects the requirements for an investigator to be considered qualified to conduct a clinical trial under Malaysian GCP?

• The investigator must be a certified specialist in the disease area under investigation and have published clinical trial results in peer-reviewed journals.

• The investigator must hold an academic appointment, have completed postgraduate training, and be approved by the sponsor’s medical director.

• The investigator must have at least five years of experience in clinical trials and provide a signed declaration of ethical compliance to the IRB/IEC.

• The investigator must be qualified by education, Good Clinical Practice (GCP) training, and relevant experience, and must provide documented evidence of these upon request.

Which of the following best represents the responsibilities of an investigator regarding the medical care of trial subjects as stated in the Malaysian GCP guideline?

• Medical decisions during the trial should be made collectively by the clinical trial team, and any adverse events should be reported only if deemed serious by the sponsor.

• Only adverse events directly related to the investigational product require medical follow-up, and subjects should not be contacted once they have withdrawn from the study.

• The investigator should request a written explanation from any subject who chooses to withdraw prematurely and is required to share this with the IRB/IEC and sponsor.

• A qualified physician or dentist involved in the trial must oversee trial-related medical decisions, ensure subjects receive appropriate care for any adverse events, and may inform the subject’s primary physician with the subject’s consent.

Which of the following best reflects the investigator’s obligations regarding protocol amendments and deviations under Malaysian GCP?

• Protocol changes may be implemented immediately if deemed necessary by the investigator, provided the IRB/IEC is notified within 30 working days of the change.

• An investigator may implement a protocol deviation without sponsor or IRB/IEC approval only when the change is administrative in nature, such as updating contact information.

• No protocol changes or deviations should occur unless they are pre-approved by the IRB/IEC and agreed to by the sponsor, regardless of the urgency or reason.

• A protocol deviation or change may be implemented without prior IRB/IEC approval only when it is necessary to eliminate an immediate hazard to subjects, but must be reported afterward to the IRB/IEC, sponsor, and regulatory authority as applicable.

Which of the following is NOT required to be included in the informed consent discussion and documentation provided to clinical trial subjects under Malaysian GCP guidelines?

• An explanation that the trial involves research and a description of any anticipated risks, including those to embryos or nursing infants, when applicable.

• A statement that the subject may withdraw at any time without penalty, and that records identifying the subject will be kept confidential as per applicable laws.

• A guarantee that trial participation will provide therapeutic benefit and that all trial-related injuries will be fully covered by the sponsor.

• An explanation of alternative treatment options, the purpose of the trial, procedures to be followed, and that access to medical records may be granted for trial-related verification.