Glossary

Weakened (attenuated) viruses often used as vaccines; they can no longer produce disease but still stimulate strong immune response similar to the natural virus. Examples include oral polio, measles, mumps, and rubella vaccines.

A virulent organism that has been modified to produce a less virulent form, but nevertheless retains the ability to elicit antibodies against the virulent form.

Attribution is the process of deciding the likelihood that the adverse event is related to (or resulting from) the research. The PI must determine whether an adverse event is “unrelated”, “possibly related”, “probably related”, or “definitely related” to the study intervention or treatment. Attribution must be determined by the reporting investigator and verified by the principal investigator (The reporting investigator may, or may not be, the principal investigator).

(of a clinical trial). A systematic and independent examination of trial-related activities and documents to determine whether the evaluated trial-related activities were conducted, and the data were recorded, analyzed, and accurately reported according to the protocol, sponsor’s standard operating procedures (SOPs), good clinical practice (GCP), and the applicable regulatory requirement(s).

(ANSI) To conduct an independent review and examination of system records and activities in order to test the adequacy and effectiveness of data security and data integrity procedures, to ensure compliance with established policy and operational procedures, and to recommend any necessary changes.

An on-site evaluation by an ASME appointed team to review and report evidence of compliance of the applicant with regard to the requirements of the ASME BPE Standard, “after” issuance of a certificate.

(IEEE) An independent examination of a work product or set of work products to assess compliance with specifications, standards, contractual agreements, or other criteria.

(ISO) Systematic, independent, and documented process for obtaining audit evidence and evaluating it objectively to determine the extent to which agreed criteria are fulfilled.

A feature of the audit trail that aids both originator and reviewer in understanding why the originator performed a specific action. CFR 21 Part 11 does not require entering the reason for a record change, but some predicate rules (such as GLPs) do expect an explanation. It is important that the user interface for entering audit comments prevents users from changing the audit trail itself.

A written evaluation by the sponsor's auditor of the results of the audit.

A computer-generated and time-stamped record of who did what, when. CFR 21 Part 11 requires audit trails to be generated independently of operators. An audit trail must capture all activities related to creating, modifying, and destroying records on a system.

Chain of related documents, or entries within records, that allows related information to be traced.

Documentation that allows reconstruction of the course of events.

A chronological record of system activities that is sufficient to enable the reconstruction, reviews, and examination of the sequence of environments and activities surrounding or leading to each event in the path of a transaction from its inception to output of final results.

A sequence of steps supported by proof documenting the real processing of a transaction flow through a process or system.

(ISO) Data in the form of a logical path linking a sequence of events, used to trace the transactions that have affected the contents of a record.

An alternative surface analysis that can detect all elements with an atomic number greater than that of helium with the additional ability to analyze sub micron-diameter features. It is not as quantitative as ESCA and cannot determine the chemical state of an element. The primary advantage of Auger is that when combined with etching, a chemical depth profile can be measured rapidly and can image the distribution on the surface of spatial limitation resolution of 100 to 1,000 angstroms (depending on the equipment capability).

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The non-magnetic form of iron characterized by a face-centered cubic lattice crystal structure. It is produced by heating steel above the upper critical transformation temperature and has a high solid solubility for carbon (about 2%) and alloying elements.