Chapter 23: Administration of systemic anticancer therapies
Skip chapter table of contents and go to main content
Definitions
(ICH [109], NIHR [174] b, RCN [202])
- Clinical trial. A clinical trial is a structured research process to investigate the safety, tolerability and efficacy of a medicinal product in human subjects or to investigate safety of medical devices in human subjects or to compare new medical approaches to a standard and routinely available process.
- GCP: Good clinical practice. A set of internationally recognized ethical and scientific quality requirements which must be observed for designing, conducting, recording and reporting clinical trials that involve the participation of human subjects (ICH [109]).
- IB: Investigator's brochure. A comprehensive document detailing information about an IMP (investigational medicinal product). It is designed to provide the investigator with IMP information necessary for the management of the study conduct and study participants’ safety throughout the clinical trial.
- ICF: Informed consent form. A specific consent document that includes details of a study participant's consent to participate in a clinical trial.
- ICH: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use. It aims to achieve greater harmonization worldwide to ensure that safe, effective and high‐quality medicines are developed and registered in the most resource‐efficient manner, by providing guidelines to conduct clinical trials.
- IMP: Investigational medicinal product. A pharmaceutical form of an active substance or placebo being tested or used as a reference in a clinical trial, including products already with a marketing authorization but used or assembled (formulated or packaged) in a way different from the authorized form, or when used for an unauthorized indication, or when used to gain further information about the authorized form.
- PIS: Patient information sheet. A document explaining in detail all relevant study information to assist the potential study participants in understanding the expectations and requirements of participation in a clinical trial.
- Protocol. A document that describes the objectives, design, methodology, statistical considerations, and organization of a clinical trial. A protocol provides an overview of the schedule of events, IMP doses, safety information about the study drug, clinical trial duration, etc.
