Glossary

In configuration management, the functional and physical characteristics of hardware or software as set forth in technical documentation or achieved in a product.

The three-dimensional shape or form of a macromolecule.

(IEEE) An element of configuration management, consisting of the evaluation, coordination, approval or disapproval, and implementation of changes to configuration items after formal establishment of their configuration identification.

Variable data that the Interactive Response Technology (IRT) system uses to make a decision, e.g., the expiry (use-by) date of an Investigational Medicinal Product (IMP) where an on-going stability program may increase the date during the life of the clinical trial.

(IEEE) An element of configuration management, consisting of selecting the configuration items for a system and recording their functional and physical characteristics in technical documentation.

(IEEE) An aggregation of hardware, software, or both that is designated for configuration management and treated as a single entity in the configuration management process.

(ITIL®) A component of a system – or a document, such as a request for change, associated with an infrastructure – which is (or is to be) under the control of configuration management. CIs may vary widely in complexity, size, and type – from an entire system (including all hardware, software, and documentation) to a single module or a minor hardware component.

Those activities necessary to precisely define an object at any point during its life cycle, e.g., manage all constituents of a specific server building block.

(ITIL®) The process of identifying and defining the configuration items in a system, recording and reporting the status of configuration items and requests for change, and verifying the completeness and correctness of configuration items.

(ITIL®) The process of identifying and defining the configuration items in a system, recording and reporting the status of configuration items and requests for change, and verifying the completeness and correctness of configuration items.

(IEEE) A discipline applying technical and administrative direction and surveillance to identify and document the functional and physical characteristics of a configuration item, control changes to those characteristics, record and report change processing and implementation status, and verifying compliance with specified requirements.

(ITIL®) A database, which contains all relevant details of each CI and details of the important relationships between CIs.

(ICH Q1B) Those undertaken to establish photostability characteristics under standardized conditions. These studies are used to identify precautionary measures needed in manufacturing or formulation and whether light resistant packaging and/or special labeling is needed to mitigate exposure to light. For the confirmatory studies, the batch(es) should be selected according to batch selection for long-term and accelerated testings which is described in the Parent Guideline.

In a clinical trial, a situation in which the interests of the researcher or institution are at odds with their professional obligation to the patient. Any potential conflicts of interest must be disclosed by the researcher to the institution. For any researcher with a significant financial interest in, or a controlling interest in, or a consulting arrangement with a private business concern, it is important to avoid actual or apparent conflicts of interest between University / FAHC obligations and outside interests and obligations.

The characteristic three-dimensional shape (tertiary structure) of a macromolecule.

Any trait or condition that exists from birth, whether the result of a genetic or nongenetic factor.

(ICH Q5C) A conjugated product is made up of an active ingredient (for example, peptide, carbohydrate) bound covalently or noncovalently to a carrier (for example, protein, peptide, inorganic mineral) with the objective of improving the efficacy or stability of the product.

A protein containing a metal or an organic prosthetic group or both. Hemoglobin is a conjugated protein.

Sexual reproduction of bacterial cells in which there is a one-way exchange of genetic material between the cells in contact.

Concept of Operations

Agreement to do something.

The result of a serious violation of federal regulations and related safety and quality standards. A company must agree to a series of measures aimed at bringing its manufacturing standards in compliance with federal regulations. Until agreed-upon conditions are met, a company may be forbidden to distribute its products in interstate commerce, except for those products deemed essential for the public health.

Required by the Common Rule. Refers to the requirement that all researchers explain the purposes, risks, benefits, confidentiality protections, and other relevant aspects of a research study to potential human subjects so that they may make an informed decision regarding their participation in the research. IRBs review the informed consent process and form documenting the consent to ensure compliance with research regulations and policies. While the HIPAA Privacy Rule permits entities to include in the informed consent form for research and the "authorization" for use or disclosure of individually identifiable health care information on the same form, it is the UVM / FAHC Committee policy to require separate documents.