A contract research organization (CRO) is a company which conducts a Good Clinical Practice (GCP) in clinical trial. There are literally hundreds of CROs worldwide employing a workforce of nearly 100,000 professionals. The project proposes the study of practical parameters and their relative importance as perceived by the various stakeholders in clinical trials. The survey was conducted in Bang...

BACKGROUND This study aimed to examine the quality in oncology registration trials for new drug application (NDA) or supplemental new drug application (sNDA) as extensions of the indications for use in Japan based on Good Clinical Practice (GCP) audit findings. MATERIALS AND METHODS We collected audit reports of on-site GCP inspections for registration trials in 383 NDAs or sNDAs that were re...

In the last issue of 'Mental Health' David Boorer examined the need for a code of practice for staff working in psychiatric hospitals and assessed the consultative and preparatory work to be done, if such a code were to be of practical value. The code, renamed guidelines', has now been drawn up and is printed here in the form in which it has been submitted to the organisations involved in its d...

THE LAST decade has seen a shift of attitude within the nursing profession towards the importance of record keeping. This change has been brought about predominantly by the promotion of patients’ rights and the empowerment of patients and relatives to be involved in their care, through the Patient’s Charter (DoH 1991). This has now been superseded by Patient Focus and Public Involvement (Scotti...

the main objective of this study is to investigate the production factors productivity in large manufacturing sub-sectors. for this purpose, using statistical data for period 1972-2004, we have tried to study and analyze the trend and level of production factors productivity (partial and total productivity) in each sub-sectors classified according to isic two digits code. the average and margin...

Good Clinical Practice (GCP) provides an internationally accepted standard to ensure subject safety and data quality in clinical trials. Much of GCP parallels ethical considerations that have accumulated in successive versions of the World Medical Association's Declaration of Helsinki. This document advocates for preservation of rights, safety, and well-being of human study participants. By con...