GOOD CLINICAL PRACTICE ICH E6(R2) INTRODUCTION Good Clinical Practice (GCP) is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. Compliance with this standard provides public assurance that the rights, safety and Informed consent means that the purpose of the research is explained to them, including what their role would be and how the trial will work. A central part of the informed consent process is the The principles cover thirteen core themes for sound and safe clinical trials. Ethical Principles - Clinical trials should be conducted in accordance with good clinical practice (GCP) and applicable regulatory requirements. Safety as a Priority - Clinical trial activity should be designed to ensure participant rights, safety, and well-being GCP Research is a facility where Phase 2 and 3 trials take place. A Phase 2 study is to assess the level of safety and efficacy of the investigational drug. A Phase 3 study is to assess the effectiveness of the investigational drug compared to current standard treatment. Clinical trials are essential to the development of all medication that is Good Clinical Practice (GCP) is the international, ethical and scientific quality standard to which all research involving human participants is conducted. Cloud services are constantly evolving. All information in this cheat sheet is up to date as of publication. We will periodically update the list to reflect the ongoing changes across all three platforms. Download the PDF version to save for future reference and to scan the categories more easily. Here is our cloud services cheat sheet of the A research protocol is a document that describes the background, rationale, objectives, design, methodology, statistical considerations, and organization of a clinical research project. According to the ICH Good Clinical Practice guidelines, a protocol should include the following topics: The most important purpose of source documentation in a clinical trial is to reconstruct the trial as it happened. It should enable an independent observer to reconfirm the data. Documentation should be such that it is able to provide audit trail to permit investigation if and when required. Good Clinical Practice (GCP) is the international ethical, scientific and practical standard to which all clinical research is conducted. Compliance with GCP provides public assurance that the rights, safety and wellbeing of research participants are protected and that research data are reliable. This 75-minute online training course is intended to introduce Veterinary Good Clinical Practices (vGCP) and geared towards any individual involved in the design, conduct, monitoring, recording, auditing, analysis and reporting of clinical studies in veterinary patients. Compliance with vGCP assures transparent data collection, humane treatment 3RydLiT.

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