What are the 13 principles of ICH GCP?
Ethics.
What is protocol as per ICH GCP?
A protocol is a document that describes the background, rationale, objectives, design, methodology, statistical considerations, and organization of a clinical research study. The ICH Good Clinical Practice Guidelines specify some topics that should generally be included in a protocol.
What is ICH R2 guidelines?
ICH E6(R2) adds in the introduction section a requirement to specify that both the sponsor and investigator/ institution (site) conducting the trial should maintain their respective essential documents in a system that provides processes for locating the document, as well as providing for document identification.
What is E6 in ICH?
ICH E6 Good Clinical Practice (GCP) Guideline is widely used by clinical trial researchers beyond the membership and regional representation of ICH itself and has a significant impact on trial participants and patients.
What is Pi in IRB?
The Principal Investigator (PI) is ultimately responsible for assuring compliance with applicable University IRB policies and procedures, DHHS Federal Policy Regulations, and FDA regulations and for the oversight of the research study and the informed consent process.
What are new ICH guidelines?
The New ICH GCP E6 R2 Guideline is a conference that covers topics such as: Challenges and opportunities in implementing the new guidance.
What is ICH GCP guidelines?
FDA Guidance for Good Clinical Practice (GCP) is an international quality standard defined by the International Council for Harmonization (ICH) that governs ethical and scientific considerations for designing, conducting, recording and reporting trials involving human subjects.
What should be included in a protocol?
According to the ICH Good Clinical Practice guidelines, a protocol should include the following topics: Title Page (General Information) Background Information. Objectives/Purpose. Study Design. Selection and Exclusion of Subjects. Treatment of Subjects. Assessment of Efficacy.
What is Ich research?
Intracerebral Hemorrhage (ICH) Research and Clinical Trials. Intracerebral hemorrhage (ICH) is the most devastating type of stroke for which there are no proven effective treatments other than conservative management and supportive care. ICH is defined as a sudden bleeding episode in the brain tissue or ventricles.