Clincal terminology Different names of SAS programer 1)Bio analyst 2 Clinical data analyst 3)SAS programer 4)Bio Statstician

2) Protocol: Procedures and details of the particular study. 3) In the Clinical deparment we have Bio stat, Clinical research associate. R egulatory (who interfaces Directly with FDA). investigator : author of the proto col and author of crucial treatment plan. principal investigator : who controlls everyone includes investigator. 4)FDA : Food and drug adminstration 5) A controlled experiment is in between PLACEBO controlled group (no active dr ug) to the ACtive drug subjects with in the contorlled clinical trails. 6) EDC :Electronic data capture which gives faster about the clinical informatio n, some times EDC referred as computerassisted Date collection. 7) CFR Part 11 (Code of federal regulation part 11) : it Particularly deals with Creation amd maintainance of Electronic records. 8) All the information collected written down on a CRF (case report form). which contains demographic and adverse events. the medical history collected on its o wn form seperate from the demographic form called adverse events form which contains side affects and adverse affects from the dru g or other treatments. This all information is called source data. which is impo rtant data to reconstuct the study if necessary. STUDY DESIGN; Subjects are randomised in to the different groups. subjects are t reated with Placebo and active drug , statstical significance is measured betwee n the active subjects gruop and placebo group. subjects dont know which grup has activce drug called single blinded study . a s tudy no one knows contains the active group called DB.if it all open the study c alled openlable study. the toxcity measured between the subjects taken the active drug groups three tim es a day and twice a day. all has written in to the crf. TABLES LISTINGS AND GRAPHS: listings : listings are generated between the concomitant drugs and active treat ment drugs. these listings are generated becuase to show the bioequilance betwee n the active treatment drug and patients who already taking the other drugs. the listings are produced in chrnological order by subje ct identification number. producing the listings are relatively easier then tabl es ang graphs. one challenging aspect of producing the listings is genric name of concomitant d rug. a trade name can not be used in listings, a dictinory is available on WHO for particular trade name to the genric drug. another challenging aspect on producing listings to the name of the adverse re actions. In this case we can use COSTART ( code names to the adverse reactions). the data management group is moving to MedRA (medical dictionary regulatory act

ivities).