Journal of Developing Drugs
Open Access

GCP and implementation in an academic environment

2^nd International Summit on GMP, GCP & Quality Control

November 12-14, 2013 DoubleTree by Hilton Hotel Chicago-North Shore, IL, USA

Leonie J. Crampton

Accepted Abstracts: J Develop Drugs

Abstract :

Until recently, all research work at the Kirby Institute, HEPP Program has included behavioural risk surveillance, studies of risk behaviour and studies of use of biomedical preventive interventions. Challenges have arisen within the program following the introduction of a clinical trial. This presentation will describe the challenges in implementing good clinical practice to the academic researchers and a case study describing the issues that occurred prior to implementation of GCP.

Biography :

Leonie J. Crampton qualified in nursing and midwifery prior to commencing a career in research which has included working in academic research institutions and the pharmaceutical industry. She has held a variety of research roles, including study coordinator, clinical research associate, project manager, clinical feasibility leader and senior medical quality associate. She is the inaugural clinical project manager in the HIV Epidemiology and Prevention Program (HEPP) at The Kirby Institute to assist in the coordination and management of HIV, HIV-related cancer and related prevention studies. She is currently working on the SPANC study which is the "Study of the Prevention of Anal Cancer". The study will provide important information to guide the possible future introduction of anal cancer screening programs and treatment for gay men