Entry Level SAS Programmers
|Statistical Programmer:requires him to program using the SAS language to analyze clinical data and produce reports for the FDA||
Bioanalyst, Clinical Data Analyst, Statistical Programmer Analyst and SAS Programmer: same as Statistical programmer.
Biotechnology:companies which is a general term used to explain a technique of using living organisms within biological systems to develop micro-organisms for a particular purpose.
protocol:outlined all the procedures and contained detailed plans of the study.
|controlled experiment: the clinical trial had patients grouped into different groups such as those in the placebo controlled group which had no active drug. This is how comparisons are made within the controlled clinical trial||CFR Part 11:Code of Federal Regulations set by the FDA to regulate food, drug, biologics and device industries. The part 11 specifically deals with the creation and maintenance of electronic records.|
|Case Report Form or CRF:forms to collect information such as demographic and adverse events.||Source Data or the information collected:which include important documents because they contain the core information required to reconstruct the essential capital of the study.|
|sponsor:company who is responsible for the management, financing and conduct of the entire trial.||randomized: subjects that are randomly assigned to groups so that each subject has an equal chance to be assigned to the placebo control|
|baseline: subjects are assigned to their drug||change from baseline:analyses that measure differences between baseline and current visit|
|placebo or sugar pill:is an inactive substance designed to look like the drug being tested.||blinded:they do not know if the drug that they are taking contains the active ingredient.|
|open-label study:all was out in the open, the drug the subject is assigned to.||Pharmacokinetics or PK:analysis of that study showed that with that dosing level, there were high levels of toxicity in the subject.|
|informed consent: described all the potential benefits and risks involved.||TLGs: Tables, Listings and Graphs|
|trade name:drug name that is collected from the patient and recorded into the source data. For example: Tylenol||generic name: refers to its chemical compound. For example: Acetaminophen.|
|WHO-DRUG: list all the drug names and how they matched to the generic drug names.This dictionary is managed by the World Health Organization||MedDRA:This is short for Med (Medical), D (Dictionary), R (Regulatory), and A (Activities).|
|SAP: Statistical Analysis Plan||ANOVA: analysis of variable|
|confidence interval:gives an estimated range of values being calculated from the sample of patient data that is currently in the study.||null hypothesis:lack of difference between the groups in a report|
|pilot study:perform the same analysis upon an older.||DIA: Drug Information Association|
|CBER: Center for Biologics Evaluation and Research (medical device)||CDER: Center for Drug Evaluation and Research (drug)|
Source:CDER Acronym List
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.