rahulrabbit the awesome

1. ICH-GCP
DIFFERENT SECTIONS
by RAHUL
challarahul77@gmail.com

2. 1.GLOSSARY
Adverse Drug Reaction (ADR)
Adverse Event (AE)
Amendment (to the protocol)…………
2.PRINCIPLES
Clinical trials should be conducted in accordance with the ethical
principles that have their origin in the Declaration of Helsinki, and that
are consistent with GCP and the applicable regulatory requirement(s).
3.(IRB/IEC)
An IRB/IEC should safeguard the rights, safety, and well-being of all trial
subjects. Special attention should be paid to trials that may include
vulnerable subjects

3. 4.INVESTIGATOR
The investigator(s) should be qualified by education, training, and experience
to assume responsibility for the proper conduct of the trial, should meet all
the qualifications specified by the applicable regulatory requirement.
The investigator should be thoroughly familiar with the appropriate use of the
investigational product(s),
5.SPONSOR
The sponsor is responsible for implementing and maintaining quality assurance
and quality control systems with written SOPs to ensure that trials are
conducted .

4. 6.PROTOCOL
The contents of a trial protocol should generally include Protocol title,
protocol identifying number, and date. Any amendment should also bear
the amendment numbers and dates.
May be contained in other protocol referenced documents, such as an
Investigator’s Brochure .
7.Investigators’ Brochure
Its purpose is to provide the investigators and others involved in the trial
with the information key features of the protocol, such as the dose,
dose frequency/interval, methods of administration and safety
monitoring procedures.

5. 8.ESSENTIAL DOCUMENTS
Essential Documents are those documents which individually and
collectively permit evaluation of the conduct of a trial and the quality of the
data produced.
These documents serve to demonstrate the compliance of the investigator,
sponsor and monitor with the standards of Good Clinical Practice and with
all applicable regulatory requirements.