ACRP, E6 REVIEW FOR CCRP

ICH stands for

The GCP is ensures that international_______ and scientific quality ____________ of human subjects clinical research are involved in the clinical research of human subjects

The GCP guidelilne is to provide a unified standard for what countries to facilitate the mutual acceptance of clinical data by the regulartory authorities.

An unintended noxious response to any dose and formulation of a drug

For an adverse drug reaction to occur, what must exist between the drug and the event/reaction?

An occurance of an unintended sign or lab result from a drug that is a result of a drug interaction.

An adverse event or and adverse drug reaction does not require a causal relationship with the drug and the unintended sign?

Name the 5 steps of a clinical audit

An audit can be conducted by the principle investigator of the study

Necessary documents for the IRB/IEC

The IRB protects the welfare and rights of_______subjects

IRB review notification involves feedback on the trial, documents and dates of

Name the type of paperwork submitted by PI to show qualifications

What is the min amount of reviews for the IRB/IEC

The IRB/IEC may request additional info be made available for trial subjects if it is meaningful to protect the ----,--------- and --------- of the subjects