CDISC Clinical Research “A” Terminology

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 characteristicsContinue reading “CDISC Clinical Research “A” Terminology”

Clinical Trials Terminology for SAS Programmers

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 systemsContinue reading “Clinical Trials Terminology for SAS Programmers”

FDA Compliance: Part 11 Checklist

PART 11 Checklist Rule Sec. Requirement Satisfied? 11.10(a) Validation of Systems The system is validated (Documentation, Testing and Maintenance) Yes/NO/NA 11.10(k-1) Adequate controls over documentation Controls are present for the distribution, access and use of systems documentation for operation and maintenance Yes/NO/NA 11.10(d) Limiting system access System access is limited to only authorized individuals. Yes/NO/NAContinue reading “FDA Compliance: Part 11 Checklist”