Preparation and certification of IRMM-1000a (20 mg) and IRMM-1000b (50 mg) - Certified uranium reference material for the production date

This report describes the development and certification of IRMM-1000a and IRMM-1000b, a uranium reference material certified for the production date based on the 230Th/234U radiochronometer. The certified value was assigned following ISO Guide 34:2009 [ ]. The starting material was low-enriched uranium with a relative mass fraction, m(235U)/m(U) of 3.6%. The chemical separation of the 230Th decay product from its parent nuclide 234U to the maximum extent of completeness was achieved. The certified production date was confirmed using the 230Th/234U radiochronometer, and corresponds to the last chemical separation, i.e. the removal of 230Th from the material to the maximum extent achievable. The between unit-homogeneity and the stability of the certified value were assessed in accordance with ISO Guide 35:2006 [ ]. The material was characterised by taking into account the date and time elapsed of the last chemical and complete separation of 230Th from 234U. The completeness of the separation was confirmed firstly by determining the U/Th separation factors and uranium recoveries using -ray spectrometry, and then by means of ICP-MS measurements using a 232Th tracer. After sufficient ingrowth of thorium into the characterised uranium reference material, measurements of the 234U and the 230Th amount contents were carried out by isotope dilution mass spectrometry (IDMS) in compliance with ISO/IEC 17025:2005 [ ]). Subsequently, the determined n(230Th)/n(234U) was used in the calculation to confirm the certified production date. The uncertainty of the certified value was estimated in compliance with the Guide to the Expression of Uncertainty in Measurement (GUM) [ ] and includes uncertainties related to characterisation, possible inhomogeneity and instability. The material is intended for calibration of methods, quality control, and assessment of method performance with isotope mass spectrometry and radiometry techniques. As any reference material, it can also be used for control charts or validation studies. The certified reference material is available in two sizes: 20 mg (IRMM-1000a) and 50 mg uranium (IRMM-1000b) as dried uranyl nitrate in screw-cap Teflon (PFA) vials. There is no minimum sample intake to be taken into account.JRC.D.2-Standards for Innovation and sustainable Developmen

IRMM-1000a and IRMM-1000b: uranium reference materials certified for the production date based on the 230Th/234U radiochronometer Part II: Certification

The IRMM-1000a and IRMM-1000b uranium reference materials, of 20 mg uranium and 50 mg uranium, respectively, were produced by the European Commission Joint Research Centre’s Institute for Reference Materials and Measurements (EC-JRC-IRMM) in collaboration with the Institute for Transuranium Elements (EC-JRC-ITU). They are the first uranium reference materials certified for the production date based on the 230Th/234U radiochronometer, i.e. the date of the last chemical separation of these two radionuclides. Such certified reference materials (CRMs) are required for proper validation of measurement procedures in Nuclear Forensics in order to determine the "age" of uranium samples and to establish traceability of the measurement results to the SI. The certified reference value and its uncertainty, homogeneity and stability of the material were established in accordance with the ISO Guide 34:2009 and the 'Guide to the Expression of Uncertainty in Measurement'.JRC.D.4-Standards for Nuclear Safety, Security and Safeguard

REIMEP-22 U age dating - Determination of the production date of a uranium certified test sample Inter-laboratory comparison, Report to participants

The REIMEP-22 inter-laboratory comparison (ILC) "U Age Dating - Determination of the production date of a uranium certified test sample" was organised by JRC-IRMM as support to the Nuclear Forensics International Technical Working Group (ITWG) This ILC was organised prior to the release of the candidate certified reference material IRMM-1000, produced in cooperation with JRC-ITU. The aim of REIMEP-22 was to determine the production date of the uranium certified test sample (i.e. the last chemical separation date of the material) using the disequilibrium between the 230Th-234U and 231Pa-235U nuclides as chronometers. The first was compulsory, the latter optional. Participants in REIMEP-22 received either a 20 mg or 50 mg low-enriched uranium sample of known age in solid uranyl nitrate form, depending on the type of analytical technique they used. Participating laboratories were asked to measure and report either the isotope amount ratio n(230Th)/n(234U) for the 20 mg uranium samples or the activity ratio A(230Th)/A(234U) for the 50 mg uranium samples and to report the calculated production date of the certified test samples. The participants were asked to apply their standard analytical procedures and report the results with the associated uncertainties. REIMEP-22 was announced to participants in June 2013 and fourteen laboratories registered for REIMEP-22 by October 2013. The shipment of the samples to the participants took place between December 2013 and late January 2014. Finally, by May 2014, nine laboratories reported results for the 20 mg uranium sample (using mass spectrometry and reporting amount ratios) and four laboratories for the 50 mg uranium sample (using gamma-spectrometry and reporting activity ratios). The reported measurement results have been evaluated against the certified reference value by means of zeta-scores in compliance with international guidelines. In general the REIMEP-22 participants' results were satisfactory. This report presents the REIMEP-22 participants' results; including the evaluation of the questionnaire.JRC.D.4-Standards for Nuclear Safety, Security and Safeguard

The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design

Abstract: Adaptive designs (ADs) allow pre-planned changes to an ongoing trial without compromising the validity of conclusions and it is essential to distinguish pre-planned from unplanned changes that may also occur. The reporting of ADs in randomised trials is inconsistent and needs improving. Incompletely reported AD randomised trials are difficult to reproduce and are hard to interpret and synthesise. This consequently hampers their ability to inform practice as well as future research and contributes to research waste. Better transparency and adequate reporting will enable the potential benefits of ADs to be realised. This extension to the Consolidated Standards Of Reporting Trials (CONSORT) 2010 statement was developed to enhance the reporting of randomised AD clinical trials. We developed an Adaptive designs CONSORT Extension (ACE) guideline through a two-stage Delphi process with input from multidisciplinary key stakeholders in clinical trials research in the public and private sectors from 21 countries, followed by a consensus meeting. Members of the CONSORT Group were involved during the development process. The paper presents the ACE checklists for AD randomised trial reports and abstracts, as well as an explanation with examples to aid the application of the guideline. The ACE checklist comprises seven new items, nine modified items, six unchanged items for which additional explanatory text clarifies further considerations for ADs, and 20 unchanged items not requiring further explanatory text. The ACE abstract checklist has one new item, one modified item, one unchanged item with additional explanatory text for ADs, and 15 unchanged items not requiring further explanatory text. The intention is to enhance transparency and improve reporting of AD randomised trials to improve the interpretability of their results and reproducibility of their methods, results and inference. We also hope indirectly to facilitate the much-needed knowledge transfer of innovative trial designs to maximise their potential benefits. In order to encourage its wide dissemination this article is freely accessible on the BMJ and Trials journal websites.“To maximise the benefit to society, you need to not just do research but do it well” Douglas G Altma

The Euratom Safeguards On-site Laboratories at the Reprocessing Plants of La Hague and Sellafield

In the European Union, nuclear material is reprocessed from irradiated power reactor fuel at two sites ¿ La Hague in France and Sellafield in the United Kingdom. These are the largest nuclear sites within the EU, processing many hundreds of tons of nuclear material in a year. Under the Euratom Treaty, the European Commission has the duty to assure that the nuclear material is only used for declared purposes. The Directorate General for Energy (DG ENER), acting for the Commission, assures itself that the terms of Article 77 of Chapter VII of the Treaty have been complied with. In contrast to the Non Proliferation Treaty, the Euratom Treaty requires to safeguard all civil nuclear material in all EU member states ¿ including the nuclear weapons states. The considerable amount of fissile material separated per year (several tonnes) calls for a stringent system of safeguards measures. The aim of safeguards is to deter diversion of nuclear material from peaceful use by maximizing the chance of early detection. At a broader level, it provides assurance to the public that the European nuclear industry, the EU member states and the European Union honour their legal duties under the Euratom Treaty and their commitments to the Non-Proliferation Treaty. Efficient and effective safeguards measures are essential for the public acceptance of nuclear activities.JRC.E.7-Nuclear Safeguards and Forensic

The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design.

Adaptive designs (ADs) allow pre-planned changes to an ongoing trial without compromising the validity of conclusions and it is essential to distinguish pre-planned from unplanned changes that may also occur. The reporting of ADs in randomised trials is inconsistent and needs improving. Incompletely reported AD randomised trials are difficult to reproduce and are hard to interpret and synthesise. This consequently hampers their ability to inform practice as well as future research and contributes to research waste. Better transparency and adequate reporting will enable the potential benefits of ADs to be realised.This extension to the Consolidated Standards Of Reporting Trials (CONSORT) 2010 statement was developed to enhance the reporting of randomised AD clinical trials. We developed an Adaptive designs CONSORT Extension (ACE) guideline through a two-stage Delphi process with input from multidisciplinary key stakeholders in clinical trials research in the public and private sectors from 21 countries, followed by a consensus meeting. Members of the CONSORT Group were involved during the development process.The paper presents the ACE checklists for AD randomised trial reports and abstracts, as well as an explanation with examples to aid the application of the guideline. The ACE checklist comprises seven new items, nine modified items, six unchanged items for which additional explanatory text clarifies further considerations for ADs, and 20 unchanged items not requiring further explanatory text. The ACE abstract checklist has one new item, one modified item, one unchanged item with additional explanatory text for ADs, and 15 unchanged items not requiring further explanatory text.The intention is to enhance transparency and improve reporting of AD randomised trials to improve the interpretability of their results and reproducibility of their methods, results and inference. We also hope indirectly to facilitate the much-needed knowledge transfer of innovative trial designs to maximise their potential benefits. In order to encourage its wide dissemination this article is freely accessible on the BMJ and Trials journal websites."To maximise the benefit to society, you need to not just do research but do it well" Douglas G Altman

The adaptive designs CONSORT extension (ACE) statement: a checklist with explanation and elaboration guideline for reporting randomised trials that use an adaptive design.

Adaptive designs (ADs) allow pre-planned changes to an ongoing trial without compromising the validity of conclusions and it is essential to distinguish pre-planned from unplanned changes that may also occur. The reporting of ADs in randomised trials is inconsistent and needs improving. Incompletely reported AD randomised trials are difficult to reproduce and are hard to interpret and synthesise. This consequently hampers their ability to inform practice as well as future research and contributes to research waste. Better transparency and adequate reporting will enable the potential benefits of ADs to be realised.This extension to the Consolidated Standards Of Reporting Trials (CONSORT) 2010 statement was developed to enhance the reporting of randomised AD clinical trials. We developed an Adaptive designs CONSORT Extension (ACE) guideline through a two-stage Delphi process with input from multidisciplinary key stakeholders in clinical trials research in the public and private sectors from 21 countries, followed by a consensus meeting. Members of the CONSORT Group were involved during the development process.The paper presents the ACE checklists for AD randomised trial reports and abstracts, as well as an explanation with examples to aid the application of the guideline. The ACE checklist comprises seven new items, nine modified items, six unchanged items for which additional explanatory text clarifies further considerations for ADs, and 20 unchanged items not requiring further explanatory text. The ACE abstract checklist has one new item, one modified item, one unchanged item with additional explanatory text for ADs, and 15 unchanged items not requiring further explanatory text.The intention is to enhance transparency and improve reporting of AD randomised trials to improve the interpretability of their results and reproducibility of their methods, results and inference. We also hope indirectly to facilitate the much-needed knowledge transfer of innovative trial designs to maximise their potential benefits. In order to encourage its wide dissemination this article is freely accessible on the BMJ and Trials journal websites."To maximise the benefit to society, you need to not just do research but do it well" Douglas G Altman