Glossary H through M
Hand-Washing Facilities – A facility providing an adequate supply of running potable water, soap, and single-use towels or hot air drying machines.
HAV – Hepatitis A Virus.
HBV – Hepatitis B Virus.
HCV – Hepatitis C Virus
HIV – Human Immunodeficiency Virus, the causative agent in Acquired Immune Deficiency Syndrome (AIDS).
ICH – International Conference on the Harmonization of Technical Requirements for registration of Pharmaceuticals for Human Use – a group of worldwide regulatory agencies and professional trade organizations formed to provide global standards for pharmaceutical development in the U.S., Europe, and Japan.
IND – Investigational New Drug Application.
IND Study – Study conducted in accordance with the requirements of the FDA Investigational New Drug regulations.
Indemnification – Process to relieve the investigator, subinvestigators, IRB/IEC, and/or research institution of responsibility against hurt, loss, or damage to subjects resulting from participation in a clinical trial.
Independent Ethics Committee (IEC) – An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical/scientific professionals and nonmedical/nonscientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving/providing favorable opinion on the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. The legal status, composition, function, operations, and regulatory requirements pertaining to Independent Ethics Committees may differ among countries, but should allow the Independent Ethics Committee to act in agreement with GCP as described in this guideline. (ICH)
Informational Translation – Informational translations are used where the original document remains the reference document, but translations of all or part of it will assist other parties in the review of documents. Examples are the translation of all or part of the local Investigational Ethics Committee approval letter or an Investigator CV.
Informed Consent Document – A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. Informed consent is documented by means of a written, signed, and dated informed consent form. (ICH)
Informed Consent Document prepared in nontechnical language to provide clinical trial subjects with information detailing trial procedures, potential benefits, risks and inconveniences, and the subject’s rights. This document is used to obtain proof of the subject’s agreement to enter a study.
Inspection – The act by a regulatory authority(ies) of conducting an official review of documents, facilities, records, and any other resources that are deemed by the authority(ies) to be related to the clinical trial and that may be located at the site of the trial, at the sponsor’s and/or contract research organization’s (CRO) facilities, or at other establishments deemed appropriate by the regulatory authority(ies.
Installation Qualification (IQ) – Documented evidence that installation instructions were followed for computer system hardware and/or software.
Institutional Review Board (IRB) – An independent body constituted of medical, scientific, and nonscientific members, whose responsibility it is to ensure the protection of the rights, safety, and well-being of human subjects involved in a trial by, among other things, reviewing, approving, and providing continuing review of trials, of protocols and amendments, and of the methods and material to be used in obtaining and documenting informed consent of the trial subjects.
Interactive Voice Response System (IVRS) – Automated central randomization system allowing investigators to obtain subject randomization information by telephone by use of interactive voice technology or a touch-tone keypad. IVRS systems may also control distribution of investigational product to sites.
International Conference on Harmonisation (ICH) – Group of worldwide regulatory agencies and professional trade organizations formed to provide harmonization of technical requirements for the development of pharmaceutical products.
Investigational New Drug Application (IND) – The application for an exemption from the U.S. Federal law requiring an approved NDA prior to shipping a drug in interstate commerce. The IND contains the clinical development plan for the drug, including as complete a picture as possible of the compound (e.g., structural formula), chemistry and manufacturing information, and the results of animal pharmacology and toxicology studies with the drug.
Investigational Product – A pharmaceutical form of an active ingredient or placebo being tested or used as a reference in a clinical trial, including a product with a market authorization when used or assembled (formulated or packaged) in a way different from the approved form, or when used for an unapproved indication, or when used to gain further information about an approved use.
Investigational Product Labels – Labels attached to inner and outer containers of investigational products containing all information sufficient to identify the product and meet local regulations for such products.
Investigational Product Release – Regulatory compliance personnel’s authorization to ship investigational product.
Investigator – One or more persons responsible for the practical performance of a clinical trial and for the integrity, health, and welfare of the subjects during the trial. The investigator is an appropriately qualified, trained, and experienced person, particularly in the clinical area of the proposed trial, who is familiar with the background and the requirements of the study. 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.
Investigator Meeting – Meeting to provide training to investigators and other trial site staff on all aspects of a clinical study.
Investigator Site File – File that is prepared for or by the investigator prior to study initiation and contains copies of documents relating to the clinical study. It is kept at the trial site, updated by the investigator and reviewed by the monitor at the monitoring visits. It must be retained by the investigator for a fixed period after the study is completed. Also known as Site Regulatory Binder or Regulatory Binder.
Investigator’s Brochure – A compilation of the clinical and nonclinical data on the investigational product(s) that is relevant to the study of the investigational product(s) in human subjects. The information must be updated during the course of the clinical program, as new data are generated.
IRMER – Ionising Radiation (Medical Exposure) Regulations (2000).
Laboratory – A workplace where diagnostic or other screening procedures are performed on blood or other potentially infectious materials.
Licensed Healthcare Professional – A person whose legally permitted scope of practice allows him or her to independently perform the activities required.
Manufactured or Fabricated Data – Data or information created without performing the tasks required to get the data. This includes data that is not supported by the presence of reasonably expected source documentation. An example of a fabricated document includes a document that has been created and submitted for a particular study subject, but that does not actually belong to that subject and lacks source documentation for items such as lab findings, chest x-rays, and concomitant medications.
Meaningful Pain Relief – The time point at which the patient feels that they have had a significant amount of pain relief post dose.
Monitor – See Clinical Research Associate.
Monitoring – The act of overseeing the progress of a clinical trial, and of ensuring that it is conducted, recorded, and reported in accordance with the Protocol, SOPs, GCP, and the applicable regulatory requirement(s).
Multicenter Trial/Study – A clinical trial conducted according to a single Protocol but at more than one site, and, therefore, carried out by more than one investigator.