Prestudy

For example, there was often no control of “other variables” or any “prestudy” and “poststudy” observations. ❋ James E. Austin (2000)

With this degree of prestudy, I could concentrate on looking and reacting, and the details automatically fell into place. ❋ Broughton, Jack, 1925- (1969)

I didn’t prestudy, Jen confessed, her face turning slightly crimson. ❋ Steve Giegerich (2001)

The purpose of inspections is to ensure the protection of Many sites report cash fl ow problems either research subjects and the integrity of data sub - because they accepted studies with insuf fi cient mitted to the agency in support of a marketing budgets, the sponsor or CRO is very slow to pay application. for work already done, or the site failed to negotiate Generally, inspections are done by appointment reimbursement for prestudy work. ❋ Martins0105 (2009)

(Lamberti, 2005). inspections through its Bioresearch Monitoring There is also research to suggest that prestudy Program (Information Sheets, 1998): work can quickly reach $10,000 US before Study-oriented • Time spent procuring the study, developing a Investigator-oriented proposal and meeting with pre-study site selector • Preparation of paperwork necessary for the Bioequivalence study. study, that is tracking forms and screening forms • Regulatory submissions The study-oriented inspection is conducted almost • Time spent for study initiation, typically an entire day exclusively to audit trials that are important to • Time spent training hospital staff, nursing and product evaluation such as NDAs and product pharmacy personnel if study has an inpatient license applications (PLAs) pending before FDA. component The inspection consists of two parts: the facts Figure 11.7 Start-up expenses ❋ Martins0105 (2009)