1. What is the purpose of the institutional review board?

The purpose of the IRB is to ensure the protection of the rights,

safety and well being of trial subjects. It reviews, approves and
provides continuing review of trial protocols and amendments and
of the methods and material to be used in obtaining and
documenting informed consent of the trial subjects.
2. What are "essential documents"?
Essential documents are the documents that individually and
collectively permit evaluation of the conduct of the study and the
quality of the data produced.
3. What are investigator-initiated studies?
Investigator-initiated studies are the clinical trials where the
investigator or institution (academic, private or governmental)
serves as a sponsor.
4. What is the relevance of Title 21 in the Code of Federal
Regulations?
Title 21 in the Code of Federal regulation is reserved for rules of
the Food and Drug Administration.
5. What is the difference between case report form and source
documentation?
Case report form is a printed, optical or electronic document used
to record all of the protocol required information on each trial
subject that is to be reported to the sponsor.
Source documentation includes original document, data and records
involved in the clinical trial such as hospital records, subjects
diaries, pharmacy dispensing records, micro film, magnetic media,
photographic
negatives,
recorded
data
from
automated
instruments, X-rays, subject files, records kept at pharmacy, at the
laboratory.