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With a gap left between the Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) guidelines, Good Clinical Laboratory Practice (GCLP) guidelines were established to address both GCP and GLP principles in the analysis of laboratory samples from human clinical trials. This important bridge between GCP and GLP has set a unified standard
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:
Good Clinical Practice (GCP) is the international ethical, scientific, and practical standard by which all clinical research is conducted. Everyone involved in research must be properly trained or experienced to perform the tasks that have been assigned to them as per GCP (Good Clinical Practice) guidelines.
FDA oversees clinical trials to ensure they are designed, conducted, analyzed and reported according to federal law and good clinical practice (GCP) regulations. FDA's regulations and guidances
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 well-being of trial subjects are pro-
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what is gcp in research