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In Europe, a new guideline on good pharmacovigilance practices-Module II: Pharmacovigilance system master file (PSMF)-was issued, and initially came into effect on 2 July 2012, with revision on 12 April 2013. The guideline describes the PSMF, which is a detailed description of the pharmacovigilance system and supports/documents its compliance with the requirements. Establishing and maintaining a PSMF is a global activity. However, because of differences or absence of regulations, legislation or guidance documents (soft laws) across the globe, definitions of studies may be different. However, as part of the PSMF, the marketing authorisation holder in Europe should be able to produce and make available a list including data arising from all study sources (the so-called 'study list') for inspection, audit and Qualified Person responsible for Pharmacovigilance oversight. For medicinal products authorised in Europe, this study list should describe, on a worldwide basis, the status of each study/programme, the applicable country(ies), the product(s) and the main objective. Most importantly, it should distinguish between non-interventional and interventional studies (clinical trials) and should be organised by active substance. The study list should include all ongoing studies/programmes as well as all studies/programmes completed in the last 2 years and may be provided as an annex to the PSMF or separately. This article analyses the global impact of the new European PSMF requirements, with special focus on the mandatory global study list. There are distinct differences between biomedical research, market research, patient support programmes and non-interventional and interventional studies, and a decision tree to support classification is proposed. This decision tree should improve harmonisation of study assessment and minimise inter-country variability in the presentation of studies/programmes for the PSMF. [ABSTRACT FROM AUTHOR]

ABSTRACT Introduction The Cl. NPhys Trial 3 showed that attributes of nerve conduction (NC) were without significant intraobserver differences, although there were significant interobserver differences. Methods: Trial 4 tested whether use of written instructions and pretrial agreement on techniques and use of standard reference values, diagnostic percentile values, or broader categorization of abnormality could reduce significant interobserver disagreement and improve agreement among clinical neurophysiologists. Results: The Trial 4 modifications markedly decreased, but did not eliminate, significant interobserver differences of measured attributes of NC. Use of standard reference values and defined percentile values of abnormality decreased interobserver disagreement and improved agreement of judgment of abnormality among evaluators. Therefore, the same clinical neurophysiologist should perform repeat NCs of therapeutic trial patients. Conclusions: Differences in interobserver judgment of abnormality decrease with use of common standard reference values and a defined percentile level of abnormality, providing a rationale for their use in therapeutic trials and medical practice. Muscle Nerve 50: 900-908, 2014 [ABSTRACT FROM AUTHOR]

ABSTRACT Introduction The aim of this study was to test the proficiency (accuracy among evaluators) of measured attributes of nerve conduction (NC). Methods Expert clinical neurophysiologists, without instruction or consensus development, from 4 different medical centers, independently assessed 8 attributes of NC in 24 patients with diabetes mellitus (DM) on consecutive days. Results No significant intraobserver differences between days 1 and 2 were found, but significant interobserver differences were seen. Use of standard reference values did not correct for these observed differences. Conclusions Interobserver variability was attributed to differences in performance of NC. It was of sufficient magnitude that it is of concern for the conduct of therapeutic trials. To deal with interrater variability in therapeutic trials, the same electromyographers should perform all NC assessments of individual patients or, preferably, NC procedures should be more standardized. A further trial is needed to test whether such standardization would eliminate interobserver variability. Muscle Nerve 48: 369-374, 2013 [ABSTRACT FROM AUTHOR]