GCP Flashcards
1
Q
How will you explain the term ALCOA
A
This term means that documents must be Accurate,Legible, Contemporary, Original and Attributed
2
Q
What is GCP
A
Good Clinical Practice (GCP) is an international quality standard that is provided by the International Conference on Harmonization (ICH). While some countries have adopted GCP as regulation, the FDA has adopted it as guidance. GCP is much of an Industry standard and some pharmaceutical or device companies require compliance with GCP in clinical trials
international quality standard
who conduct these studies are required to comply with statutes and regulations.
These laws and regulations are intended to ensure the integrity of clinical data
