GCP Related MCQs

The IRB/IEC must review payment amounts and methods to ensure they don't unduly influence trial subjects.

Payments to trial subjects should be divided and distributed based on progress, not fully contingent on trial completion.

Information about payment methods, amounts, and schedules must be included in the informed consent form and any subject information.

An IRB/IEC should have at least 5 members with relevant scientific, medical, and ethical expertise, including one non-scientific member and at least one independent member.

Only members who are independent of the investigator and sponsor can vote or provide opinions on trial-related matters.

Every IRB/IEC must have written rules and procedures for its operations, record-keeping, and meetings.

IRB/IEC decision-making must occur at official meetings with sufficient members (a quorum) present, as outlined in its written procedures.

Investigators can provide information on the trial, but cannot participate in deliberations or voting/opining within the IRB/IEC.

The investigator must agree to conduct the trial according to GCP, applicable regulations, the protocol, and IRB/IEC approval.

The investigator agrees to follow specific procedures for recording and reporting trial data as outlined by the sponsor.

The investigator allows the sponsor to monitor, audit, and inspect the trial to ensure compliance.

The investigator must keep essential trial documents until the sponsor instructs otherwise.

The sponsor is responsible for defining, establishing, and allocating all trial-related duties and functions.

The sponsor should provide insurance or indemnify the investigator against claims arising from the trial, except for negligence or malpractice.

The sponsor's procedures should address the costs of treating trial subjects for trial-related injuries.

If trial subjects receive compensation, the sponsor must ensure the methods and manner comply with regulations.

The financial aspects of the trial are documented in an agreement between the sponsor and the investigator.

Before starting a trial, the sponsor must finalize all agreements, define roles, and address financial aspects.

The sponsor is accountable for continually assessing the safety of the investigational product throughout the trial.

The sponsor must immediately inform all involved parties (investigators, institutions, regulatory authorities) if any findings could endanger participants, affect the trial, or change the approval.

The sponsor must quickly report serious and unexpected ADRs to investigators, IRBs/IECs, and regulatory agencies.

Reports of serious and unexpected ADRs must adhere to regulatory requirements and ICH guidelines.

The sponsor must submit regular safety updates and reports to regulatory authorities.

Monitoring ensures subject safety, data accuracy, and compliance with the protocol, GCP, and regulations.

Monitors are appointed by the sponsor and must have the necessary training and expertise to oversee the trial.

Monitors should be familiar with the investigational product, protocol, informed consent, SOPs, GCP, and regulations.

The sponsor decides the extent and nature of monitoring, ensuring the trial is adequately overseen.

The sponsor is responsible for ensuring that trials are sufficiently monitored to protect the rights and well-being of participants.

Good Clinical Practice (GCP) is a set of ethical and scientific quality standards for designing, conducting, recording, and reporting clinical trials. It ensures the safety, integrity, and reliability of research involving human subjects.

GCP principles are enforced by regulatory agencies, like the FDA (Food and Drug Administration) in the US and the EMA (European Medicines Agency) in the European Union.

The Institutional Review Board/Independent Ethics Committee (IRB/IEC) is a committee that reviews and approves research proposals involving human subjects to ensure their ethical and scientific validity.

The IRB/IEC reviews protocols, informed consent documents, and ensures the risks to participants are minimized, the benefits outweigh the risks, and the rights and welfare of the participants are protected.

Investigators must have the necessary medical and scientific expertise, training, resources, and experience to conduct the trial safely and competently.

Investigators are responsible for the overall conduct of the trial, ensuring compliance with the protocol, protecting the welfare of participants, and maintaining accurate records.

Investigators must have access to adequate facilities, equipment, personnel, and financial support to conduct the trial properly.

Open and timely communication is essential between the investigators, IRB/IEC, sponsor, and participants. It ensures transparency and prompt responses to any issues that arise.

The investigator and study team must follow the protocol strictly to ensure the trial is conducted consistently and accurately, as approved by the IRB/IEC.

Investigational products (drugs, devices, or other interventions) undergo testing to evaluate their safety and effectiveness in human subjects.

The lead researcher responsible for a clinical trial at a specific site, often a team effort.

A document detailing the clinical and non-clinical data about the investigational product, relevant for human testing.

A person or organization authorized by law to agree to a patient's participation in a clinical trial.

The process of observing and overseeing a clinical trial to ensure it's conducted correctly.

A clinical trial conducted at multiple sites by different investigators using a single protocol.