Trial definitions from EORTC
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.
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.