Trusted Resource for Clinical Trials, Protocols & Progress
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…
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…
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…
Read More “Ethical Oversight During Trial Conduct – Good Clinical Practice (GCP) and Compliance” »
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…
Read More “Reviewing Informed Consent Documents – Good Clinical Practice (GCP) and Compliance” »
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…
Read More “Expedited vs Full Review Criteria – Good Clinical Practice (GCP) and Compliance” »
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…
Read More “Communication Between Sponsors and ECs – Good Clinical Practice (GCP) and Compliance” »
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…
Read More “Document Requirements for EC Submission – Good Clinical Practice (GCP) and Compliance” »
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…
Read More “How Ethics Committees Assess Protocols – Good Clinical Practice (GCP) and Compliance” »
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…
Structure and Composition of Ethics Committees – Good Clinical Practice (GCP) and Compliance “Ethics Committees: Structure and Composition” Introduction Ethics committees play a pivotal role in the realm of clinical studies, ensuring that the rights, safety, and wellbeing of human subjects are prioritized. They review, approve, and monitor biomedical research to ensure ethical guidelines are…
