What is a clinical trial ICH GCP?
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.
What is ICH Guideline for Clinical Trial?
This International Conference on Harmonization (ICH) document makes recommendations on information that should be included in a core clinical study report of an individual study of any therapeutic, prophylactic, or diagnostic agent conducted in human subjects.
What is the correct definition of a 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 does ICH GCP mean?
Acronym. Definition. ICH-GCP. International Conference on Harmonisation-Good Clinical Practice (Food and Drug Administration guideline)
What is ICH guideline?
ICH Guidelines were created by The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). ICH aims to provide uniform standards for technical requirements for pharmaceuticals for human use. They are developed by regulatory and pharma industry authorities.
What are the key principles of GCP?
Three basic ethical principles of equal importance, namely respect for persons, beneficence, and justice, permeate all other GCP principles.
What is ICH Q7 guidelines?
The ICH guidance Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality.