Quick Guide to Good Clinical Practice: How to Meet International Quality Standard in Clinical Resear

1 Clinical Trials: Historical Aspects and Importance and New Drug Developments.- 2 The Definition of GCP.- 3 The Principles of GCP.- 4 The Drug Development Process and Evolution of Regulations.- 5 Planning Clinical Research.- 6 Preparation of Ethics Committee (IRB) Proposal.- 7 Preparation of Informed Consent.- 8 Preparation of Findings Tables.- 9 Setting the Ideal Statistical Methods.- 10 The Duties of a Clinical Research Coordinator.- 11 The Duties of Clinical Researchers.- 12 The Phases of Clinical Studies.- 13 Safety in Clinical Trials.- 14 Setting the Size.- 15 Setting the Ideal Method.- 16 Ethics of Clinical Research.- 17 Recruitment and Enrolment.- 18 Why we need Clinical Consent and Other Documentation.- 19 Monitoring the Trial.- 20 Inspection.- 21 Ethics - Institutional Review Board/Independent Ethics Committee(IRB/IEC).- 22 Responsibilities of the Investigator .- 23 Responsibilities of the Sponsor.- 24.Clinical Trial Protocols.