Tag: GCP oversight

How to Achieve Sample Pooling and Aliquoting Techniques with FDA/EMA Oversight

October 3, 2025

How to Achieve Sample Pooling and Aliquoting Techniques with FDA/EMA Oversight Implementing Sample Pooling and Aliquoting Techniques in Clinical Trials Under Regulatory Oversight Introduction: Why Sample Pooling and Aliquoting Require Stringent Control In large-scale clinical trials, efficient sample management is essential to minimize waste, improve throughput, and ensure timely analysis. Sample pooling and aliquoting are…

Bioanalytical Testing and Storage, Laboratory and Sample Management

Archiving and Confidentiality Obligations of ECs – Good Clinical Practice (GCP) and Compliance

July 9, 2025June 26, 2025

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Archiving and Confidentiality Obligations of ECs – Good Clinical Practice (GCP) and Compliance “Record Keeping and Privacy Duties of ECs” Introduction Archiving and confidentiality obligations are critical aspects of the responsibilities of Ethics Committees (ECs) in clinical studies. As a part of their duties, ECs are required to maintain the confidentiality of sensitive information and…

Ethics Committee Roles, Good Clinical Practice (GCP) and Compliance

Adverse Event Review and Safety Monitoring by EC – Good Clinical Practice (GCP) and Compliance

July 9, 2025June 26, 2025

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Adverse Event Review and Safety Monitoring by EC – Good Clinical Practice (GCP) and Compliance “EC’s Review of Adverse Events and Safety Monitoring” Introduction to Adverse Event Review and Safety Monitoring by EC An adverse event during a clinical trial is a significant concern that requires immediate attention. It is crucial to have a robust…

Ethics Committee Roles, Good Clinical Practice (GCP) and Compliance

Ethical Oversight During Trial Conduct – Good Clinical Practice (GCP) and Compliance

July 9, 2025June 26, 2025

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Ethical Oversight During Trial Conduct – Good Clinical Practice (GCP) and Compliance “Monitoring Ethical Compliance During Trial Execution” Introduction For the successful implementation of clinical trials, there is a need for ethical oversight throughout the trial conduct. This involves the application of ethical principles such as respect for persons, beneficence and justice. The importance of…

Ethics Committee Roles, Good Clinical Practice (GCP) and Compliance

Reviewing Informed Consent Documents – Good Clinical Practice (GCP) and Compliance

July 8, 2025June 26, 2025

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Reviewing Informed Consent Documents – Good Clinical Practice (GCP) and Compliance “Examining Informed Consent Papers” Introduction Informed consent is an essential aspect of clinical studies, as it ensures that participants understand the details of the study, including the potential risks and benefits. The informed consent document is a key part of this process, providing written…

Ethics Committee Roles, Good Clinical Practice (GCP) and Compliance

Expedited vs Full Review Criteria – Good Clinical Practice (GCP) and Compliance

July 8, 2025June 26, 2025

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Expedited vs Full Review Criteria – Good Clinical Practice (GCP) and Compliance ‘Criteria for Expedited Versus Full Review’ Introduction Before any new drug, medical device or treatment can be introduced to the market, it must undergo a rigorous review process to ensure it is safe and effective. This review process is typically conducted by a…

Ethics Committee Roles, Good Clinical Practice (GCP) and Compliance

Communication Between Sponsors and ECs – Good Clinical Practice (GCP) and Compliance

July 8, 2025June 26, 2025

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Communication Between Sponsors and ECs – Good Clinical Practice (GCP) and Compliance “Interaction Between Sponsors and Ethics Committees” Introduction Effective communication between sponsors and Ethics Committees (ECs) is crucial in the successful execution of any clinical study. It ensures ethical conduct, compliance with regulatory standards, and protection of the rights, safety, and well-being of the…

Ethics Committee Roles, Good Clinical Practice (GCP) and Compliance

Document Requirements for EC Submission – Good Clinical Practice (GCP) and Compliance

July 8, 2025June 26, 2025

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Document Requirements for EC Submission – Good Clinical Practice (GCP) and Compliance “Requirements for Submitting Documents to the EC” Introduction Submitting a clinical study to an Ethics Committee (EC) is a crucial step in the research process. This submission involves a set of documents that must adhere to the quality standards and guidelines set by…

Ethics Committee Roles, Good Clinical Practice (GCP) and Compliance

How Ethics Committees Assess Protocols – Good Clinical Practice (GCP) and Compliance

July 8, 2025June 26, 2025

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How Ethics Committees Assess Protocols – Good Clinical Practice (GCP) and Compliance “Evaluating Protocols: The Process of Ethics Committees” Introduction to Ethics Committees in Clinical Studies Before the initiation of any clinical trial, it is crucial to ensure that the protocol adheres to ethical principles. This responsibility lies primarily with the Ethics Committee (EC). The…

Ethics Committee Roles, Good Clinical Practice (GCP) and Compliance

Initial and Ongoing Ethical Review Responsibilities – Good Clinical Practice (GCP) and Compliance

July 7, 2025June 26, 2025

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Initial and Ongoing Ethical Review Responsibilities – Good Clinical Practice (GCP) and Compliance “Primary and Continuous Moral Oversight Duties” Introduction When conducting clinical studies, it is essential to maintain a strong ethical standard that ensures the safety and wellbeing of all participants involved. It’s important to not only initiate these standards at the beginning of…

Ethics Committee Roles, Good Clinical Practice (GCP) and Compliance