Dear Participants, Partners, and Collaborators,
It is with great pleasure that the TRREE team is announcing today,
December 19th, 2012, the launch of a new TRREE module: MODULE 3.2: GOOD
CLINICAL PRACTICE (GCP). This GCP module is freely available in English,
French and German. It adds an important training component for those who
develop, conduct or review clinical trials.
Module 3.2 on GCP delineates the basic GCP and regulatory requirements for
clinical trials with medicinal products for human use. Due to the
variations in rules and laws within the International Conference on
Harmonization (ICH) region and other pharmaceutical markets, each section
of the module provides references to ICH-GCP, European Union, USA-FDA and
the Swiss laws and regulations, setting forth the quality standards for the
conduct of clinical trials.
Prior to taking the GCP module, participants should already have some
knowledge of research ethics and regulation. In order to ensure that
participants this, a set of PRE-REQUISITES has been established:
Participants will need to have successfully completed TRREE modules
1-Introduction to research ethics, 2.1-Research Ethics Evaluation, and
3.1-Informed Consent. Participants who have already completed these
pre-requisite modules, may proceed to module 3.2-GCP by simply following
the instructions on the website.
A certificate of accomplishment will be provided to participants who
achieve the module with 70% of correct answers on their first try or click.
This certificate can be added to your training records as evidence of
having successfully completed a Good Clinical Practice course.
The TRREE GCP module is recognized by Swissmedic (the Swiss Drug Agency)
as basic training for investigators. The National Health Research Committee
of Nigeria has also acknowledged TRREE training for its ethics committee
members and investigators.
_Coordinateur TRREE Coordinator_
MODULE 3.2-GCP: OVERVIEW
ESTIMATED TIME TO COMPLETE: 5 - 6 hours (can be intermittent)
CONTENT: Module with 32 questions & a Quiz with 25 questions.
INTENDED AUDIENCE: Investigators, study nurses, pharmacists, members of
Ethics Committees, clinical trial monitors, staff working in pharmaceutical
companies or in Contract Research Organizations.
PRE-REQUISITE: TRREE Modules 1, 2.1 & 3.1
CREDITS: The TRREE GCP module meets Swissmedic requirements for
SPONSORS OF THIS MODULE: SwAPP (Swiss Association of Pharmaceutical
Professionals) SCTO (Swiss Clinical Trial Organization) AGEK (Swiss Ethics
Research Committee Organization)
Childrent and Clinical Consultation,as the saying goes that research with childrent is Crucial .What part would age 6,8 or 10 child play in deciding whether or not to participate in research,first of all who is a child in line with the convention on the child Rights Act 2003 defines a child as a person who has not attained the age of 18,therefore, it means any child from zero year old to 17year old is a child while a person from 18 years and above is an adult 15,16, or 17 are define as a child.Therefore the above mentioned ages can be clarify as child as define by the Act,in research are vulnerable subjects described as person who is likely to compromised autonomy related to decisions about research participationto some extend that violate th principles oin Belmont Report i.e respect for persons and persons with diminished autonomy are entitled to protection ,it is said to be difficult to decide persons who are likely to have diminished autonomy should be excluded from research preventing them from making a decision which denies them right of self determination.Researchers and IRB are to protect the vulnerable subjects e.g incapaciated ones the research plan require informed consent from a well educated and properly motivated surogate decision maker .therefore childrent have diminished autonomy because of their intellectual development legal status in the society.The childrent and the young people may be affected by the report in future to some extend but it is a wellcome development scientically and ethically to both the child and the young people.That is my humble submission on the childrent and clinical reseasrch consultation.