Glossary G-K

 

Health Outcomes
Health Outcomes measures the impact (what happens) to an individual who has received a certain treatment (could be an experimental drug, diet, exercise, etc.) Health Outcomes can include a wide range of measures, such as medical tests, frequency of doctor's visits, frequency of emergency room visits, patient satisfaction, patient preferences, and health related quality of life.
Immune system
Your body's defense system against infection and certain diseases.
In Vitro Testing
Laboratory testing that does not involve animals or humans.
In Vivo Testing
Testing in animal and humans.
Incidence
The number of new cases of infection or disease occurring in a specific population in a given time period.
Inclusion and Exclusion Criteria
The rules that determine whether or not someone is eligible to enter a clinical trial. These rules are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
Informed Consent
Informed consent means deciding if you want to take part in a study.
This decision is only made after:
1. A study staff person has explained the study
2. You understand the purpose of the study, and
3. You really understand what you will have to do while in the study.
Investigator
A person responsible for the conduct of the clinical trial at a trial site. If a trial is conducted by a team of individuals at a trial site, the investigator is the responsible leader of the team and may be called the principal Investigator.
Investigators are listed on the GSK CSR only for those study sites that proceed to enrol research subjects in to the study protocol. Investigators are not listed if the site does not enrol subjects – for example if the overall study completes before the individual site is able to begin recruitment.

For more information on this register please email GSKClinicalSupportHD@gsk.com

GSK-sponsored clinical studies are those for which GSK is ultimately responsible for all aspects of the study even if some or all of these activities are transferred to another party.
GSK-sponsored clinical trials are those for which GSK is ultimately responsible for all aspects of the study even if some or all of these activities are transferred to another party.

ClinicalTrial.gov is a database that provides summary protocol information for ongoing clinical trials.

IFPMA.org is a search portal provided by the International Federation of Pharamceutical Manufacturers & Associations (IFPMA).

This portal provides a single entry point to search for industry sponsored clinical trials which are on existing registers and databases.

EU Clinical Trials Register is a database of all clinical trials commencing in the European Community from 1 May 2004 onwards. It has been established in accordance with Directive 2001/20/EC.