SoCRA

Certification - Financial Interest and Arrangements of Clinical Investigators (Principal Investigator)

Disclosure - Financial Interest and Arrangements of Clinical Investigators. (Co-Investigators)

Application for IDE/IND's must accompany and correspondence sent to the FDA, 001

Statment of Investigators

Voluntary Reporting of Adverse Events and product problems

For use by Sponsors, Distributors, and Manufacturing for Mandatory Reporty

Notice of Inspection

Inspectional Observations

Food and Drug Administration

Good Clinical Practice - A Standard for the design, conduct, performance, monitoring, auditing, recording,, analysis, and reporting of clinical trials that provide assurance that the data and reported results are credible and accurate, and that the rights, integrity, ans confidentiality of the subjects are protected.
ICH-GCP

A person who is independent of the trial, who cannot unfairly

Independent Ethics Committee(IEC)

Institional Review Board - An independent body constituted of medical scientific and non scientific member whose responsibilty is to ensure the protection of the rights safety and wellbeing of human subjects involved in a trial by among other things, reviewing, approving, and providing continuing review of a trial procotocol and amendments and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.

Babies and military wives

Ethical yard stick that started the modern era of human subject protection.