Trial definitions from EORTC
Clinical Trial
Any systematic study on medicinal products in human subjects whether in patients or non-patients volunteers in order to discover or verify the effects of and/or identify any adverse reaction to investigational products and/or to study their absorbtion, distribution, metabolism, and excretion in order to ascertain the efficacy and saftey of the products.
Good Clinical Practice (GCP)
A standard by which clinical trials are designed, implemented, and reported so that there is public assurance that the data are credible, and that the rights, integrity and confidentiality are protected.
Protocol
A document which states the rationale, objectives and statistical design and methodology of the trial, with the conditions under which it is to be performed and managed.
Verification/Validation of Data
The procedures carried out to ensure that the data contained in the final clinical trial report match the observations.
