GCP Data Quality for Early Clinical Development

GCP data quality for early clinical development.

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...

Standard requirements for GCP-compliant data management in multinational clinical trials

BACKGROUND A recent survey has shown that data management in clinical trials performed by academic trial units still faces many difficulties (e.g. heterogeneity of software products, deficits in quality management, limited human and financial resources and the complexity of running a local computer centre). Unfortunately, no specific, practical and open standard for both GCP-compliant data mana...

Good Scientific Practice (gsp) and Good Clinical Practice (gcp)

PARGE: Parametric Geocoding Based on GCP-Calibrated Auxiliary Data

Nearly all current imaging spectroscopy data are obtained by scanning airborne systems. The stability of such systems is always worse than that of spaceborne platforms. Thus, geometric distortions occur due to variations of the flightpath as well as of the attitude (given by roll, pitch and heading angles) of the plane. These distortions cannot be corrected simply by ground control point based ...

Development of clinical guideline for early detection of critical congenital heart diseases at birth by pulse oximetry