Glossary

A short DNA or RNA fragment annealed to a template of single-stranded DNA, providing a 3’ hydroxyl end from which DNA polymerase extends a new DNA strand to produce a duplex molecule.

A method for sequencing long (>1 kb) cloned pieces of DNA. The initial sequencing reaction reveals the sequence of the first few hundred nucleotides of the cloned DNA. On the basis of these data, a primer containing about 20 nucleotides and complementary to a sequence near the end of sequenced DNA is synthesized, and is then used for sequencing the next few hundred nucleotides of the cloned DNA. This procedure is repeated until the complete nucleotide sequence of the cloned DNA is determined.

Projects In Controlled Environments 2

A project management methodology. It was developed by a UK government agency and is used extensively within the UK government as the defacto project management standard for its public projects. The methodology encompasses the management, control and Organization of a project. PRINCE2 is also used to refer to the training and accreditation of authorized practitioners of the methodology who must undertake accredited qualifications to obtain certification.

For the purpose of defining the responsible party, the principal investigator means “the individual who is responsible and accountable for conducting the clinical trial. The PI assumes full responsibility for the treatment and evaluation of human subjects, and for the integrity of the research data and results”.

The scientist or scholar with primary responsibility for the design and conduct of a research project.

The ability to say with confident assurance that only one user entered specific data or performed specific actions on a computer system and that the particular user is identifiable. If more than one user can get into the system in such a way that the audit trail cannot specify who performed what action, the principle of nonrepudiation has been violated.

A flat board that holds chips and other electronic components. The board is "printed" with electrically conductive pathways between the components.

Believed to be the tiniest infectious particle consisting entirely of hydrophobic protein (no nucleic acid, DNA, or RNA), suggested as a possible model for the causal agent of scrapie and related diseases. Prion diseases in humans and animals are transmissible, neurodegenerative, genetic disorders that attack the cortex of the brain. (Term originally derived from proteinaceous infectious particles).

A slow-acting virus-like proteinaceous infectious agent. Prions differ from viruses in that they are not known to contain either DNA or RNA. Suggested as a possible model for the causal agent of scrapie and related diseases.

(CMC-BWG) The accumulated laboratory, nonclinical, and clinical experience for a specific product quality attribute. This knowledge may also include relevant data from other similar molecules or from scientific literature.

An individual involuntarily confined in a penal institution, including persons: (1) sentenced under a criminal or civil statue; (2) detained pending arraignment, trial, or sentencing; and (3) detained in other facilities (e.g., for drug detoxification or treatment of alcoholism) under statutes or commitment procedures providing such alternatives to criminal prosecution or incarceration in a penal institution. 45CFR46.303 ©

For purposes of the HIPAA Privacy Rule, privacy means an individual's interest in limiting who has access to personal health care information.

A board of members authorized by the HIPAA Privacy Rule to approve a waiver of authorization for use and/or disclosure of identifiable health information. For research purposes, the Institutional Review Board will function as the Privacy Board.

Institution-wide notice describing the practices of the covered entity regarding protected health information. Health care providers and other covered entities must give the notice to patients and research subjects and should obtain signed acknowledgements of receipt. Internal and external uses of protected health information are explained. It is the responsibility of the researcher to provide a copy of the Privacy Notice to any subject who has not already received one. If the researcher does provide the notice, the researcher should also obtain the subject's written acknowledgement of receipt.

Access to resources or data with the capability of performing administrative tasks, e.g., create, modify, or delete user profiles in contrast to ordinary end-user access levels.

Pertactin

1. For diagnostic tests, the agent that is used to detect the presence of a molecule in a sample.2. A DNA or RNA sequence labelled or marked with a radioactive isotope or that is used to detect the presence of a complementary sequence by hybridization with a nucleic acid sample.

The separation of materials, spaces, or operations by means of operational controls to prevent their mixing or overlap.

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(ICH Q7)A documented description of the operations to be performed, the precautions to be taken and measures to be applied directly or indirectly related to the manufacture of an intermediate or API.

A set of interrelated or interacting activities which transform inputs into outputs.

A manufacturing, cleaning, packaging, or distribution operation which may be made up of a series of steps or stages.