- gcp 09erc1n1
This document provides guidance to all organisations (Sponsors and Investigators) that are required to retain and archive records in order to demonstrate compliance with Good Clinical Practice (GCP), and for all organisations that provide contract archive services for both electronic and physical records. Although aimed at GCP regulated organisations, the guidance and advice contained within this document might be of assistance to organisations that retain materials from other types of regulatory work, for example Good Manufacturing Practice (GMP).
Despite intensive research melanoma remains one of the most aggressive types of cancer by generating the most deadly form of skin tumour, characterized by a rapid metastatic progression. Recent studied have proved that metastatic cells tumour growth is induced by angiogenesis activation. One of the pro-angiogenic chemokine known to be involved in cancer processes is granulocyte chemotactic protein-2 (GCP-2). My work was dedicated to investigations of the effect of GCP-2 overexpression in B16F1 murine melanoma cells, on their tumorigenesis in vivo and invasive potential in vitro. Differences in the level of expression and secretion of this chemokine were correlated with Extracellular signal-regulated kinase (ERK1/2) phosphorylation status and found to modulate melanoma cell invasivity and pigmentation.
Bayesian: The Ultimate Choice of Clinical Trial! GCP and ICH-9 are appropriate choice to be considered for any Clinical Trial. However, it is tedious procedure to be conduct. The major issue in any Clinical Trial is sample size.The application of sample sample size is suitable to handle the issue.The Bayesian is ultimate choice to be accepted for trial having small sample size.This book is illustrated with Bayesian approach in longitudinal data analysis.
The retention and archiving of study materials and process records, raw data and source data, is a critical part of compliance with both Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). The maintenance and retention of such records provides the means by which a study, trial, process or procedure can be reconstructed and thus enabling the information and results generated to be verified. Requirements for the operation of an archive and the archiving process for electronic records are no different to the requirement of physical records which are required to be retained for regulatory or business requirements. However, due to the variety and fragility of electronic records some additional features are required. The purpose of this document is to identify and discuss these features and provide guidance on how these challenges can be met.
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