| acronym: A word formed from the beginning letters (e.g., ANSI) or a combination of syllables and letters (e.g., MedDRA) of a name or phrase. |
admission criteria:Basis for selecting target population for a clinical trial. Subjects must be screened to ensure that their characteristics match a list of admission criteria and that none of their characteristics match any single one of the exclusion criteria set up for the study. |
algorithm: Step-by-step procedure for solving a mathematical problem; also used to describe step-by-step procedures for making a series of choices among alternative decisions to reach a calculated result or decision. |
| amendment: A written description of a change(s) to, or formal clarification of, a protocol. |
analysis dataset:An organized collection of data or information with a common theme arranged in rows and columns and represented as a single file; comparable to a database table. |
analysis variables: Variables used to test the statistical hypotheses identified in the protocol and analysis plan; variables to be analyzed. |
| approvable letter:An official communication from FDA to an NDA/BLA sponsor that lists issues to be resolved before an approval can be issued. [Modified from 21 CFR 314.3;Guidance to Industry and FDA Staff |
arm: A planned sequence of elements, |
attribute (n): In data modeling, refers to specific items of data that can be collected for a class. |
| audit: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). [ICH E6 Glossary] |
audit report: A written evaluation by the auditor of the results of the audit. [Modified from ICH E6 Glossary] |
audit trail. A process that captures details such as additions, deletions, or alterations of information in an electronic record without obliterating the original record. An audit trail facilitates the reconstruction of the history of such actions relating to the electronic record. |
Source:Applied Clinical Trials
Anayansi Gamboa has an extensive background in clinical data management as well as experience with different EDC systems including Oracle InForm, InForm Architect, Central Designer, CIS, Clintrial, Medidata Rave, Central Coding, OpenClinica Open Source and Oracle Clinical.
