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ICH-GCP Guidelines are broken into four sections: QSEM - Quality, Safety, Efficacy, Multi-disciplinary. Which section lists the Investigator responsibilities?

A) Quality
B) Safety
C) Efficacy
D) Multi-Disciplinary

1 Answer

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Final answer:

Investigator responsibilities in ICH-GCP Guidelines are listed in the Multi-disciplinary section. These responsibilities prioritize participant safety, informed consent, and ethical standards in clinical trials.

Step-by-step explanation:

Investigator Responsibilities in ICH-GCP Guidelines

The ICH-GCP Guidelines detail various responsibilities and standards for the conduction of clinical trials. These guidelines are laid out in sections that encompass Quality, Safety, Efficacy, and Multi-disciplinary areas. Investigator responsibilities specifically are addressed in the Multi-disciplinary section. This segment underscores the expectation that investigators will ensure the safety and informed consent of the participants in the clinical trials they conduct, adhering to ethical research standards.

Investigators play a pivotal role in clinical research and are tasked with responsibilities such as protecting the rights and wellbeing of the subjects, ensuring the integrity of the data collected, and maintaining adherence to the study protocol. It is imperative that investigators follow these guidelines to maintain the quality and safety of clinical research, which ultimately contribute to the efficacy of medical interventions.

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