3) What are the contents of IND application and NDA? 4) What is Protocol, enlist the contents of protocol. 5) What is Investigational Brochure? 6) What is CRF and enlist the contents of CRF. 7) Why randomization is required? 8) What is CDMS? 9) What documents are to be kept at study? 10) What is Data? 11) What are the source documents? 12) What is audit trail? 13) What is descripancy resolution? 14) Define Data capture, Data validation, data base closure. 15) Elaborate 21CFR part 11., Closed system 16) What is SCDM and CDISC? 17) What is EDC and RDC? 18) What is external data? 19) What is metadata? 20) What is SDV? 21) Name some of the best EDC softwares for managing the data 22) What is clean data- error free data, which can support analysis and interpretation. 23) Enlist the principles covered under Nuremberg code.
4 YEARS
4 YEARS OF FORLORN HOPE,
A THOUSAND WORDS FULL OF WORTH,
LOTS OF LEISURE, LOTS OF PRESSURE,
IN MIDST OF ALL WHICH, SOME SEARCH FOR TREASURE,
SOME CONSIDER EVERTHING AS A RACE,
SOME CONSIDER FIND IT VERY DIFFICULT TO ATTEND THE COLLEGE,
WHILE SOME FIND IT DIFFICULT TO EVEN TIE THEIR SHOE LACE,