Deliverable D1.1 Web access platform This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 101008571 (PRISMAP). This document reflects only the view of the author(s). The Agency is not responsible for any use that may be made of the information it contains.
Deliverable D1.1 ii Project Acronym PRISMAP Project Title The European medical isotope programme: Production of high purity isotopes by mass separation Grant Agreement No. 101008571 Topic INFRAIA-02-2020: Integrating Activities for Starting Communities Project start date 01 May 2021 Nature Report Dissemination level Public Due date M03 Date of delivery M03 Lead partner SCIPROM Contributing partners ARRONAX, CERN Authors Ferid Haddad, Anne Le Penned, Celine Herault (ARRONAX), Kirsten Leufgen, Iris Dimbwadyo (SCIPROM) Reviewer Thierry Stora, Charlotte Duchemin (CERN), Maija Radzina (LU) Point of Contact Ferid Haddad Institution ARRONAX E-mail
[email protected] Phone +33-2-28-21-21-21 © PRISMAP 2021. This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.
Deliverable D1.1 iii Revision History Version Date Author Comment 0.1 16.07.2021 Ferid Haddad First draft 0.2 20.07.2021 Kirsten Leufgen, Iris Dimbwadyo Review, suggestions, questions 21.07.2021 Executive Board Discussion 0.5 22.07.2021 Kirsten Leufgen, Iris Dimbwadyo Conceptualisation, revision and completion based on EB discussion 0.6 26.07.2021 Peter Ulrich Internal review and revisions 0.7 26.07.2021 Kirsten Leufgen Review and revisions. Version for consortium internal review 0.8 27.07.2021 Charlotte Duchemin, Maija Radzina, Iris Dimbwadyo Compiled feedback from the consortium reviewers 0.85 29.07.2021 Kirsten Leufgen, Peter Ulrich, Iris Dimbwadyo Review and revisions 0.9 29.07.2021 Thierry Stora Review by the coordinator 1.0 30.07.2021 Peter Ulrich Final version, approved by the coordinator
Deliverable D1.1 iv Contents Abbreviations, Participant short names v ... v Abbreviations v … v Participant short names v Summary 1 ... 1 // Keep this line in place. It is need to fix a W ord-bug in the TOC. 1 1. Introduction 2 … 2 ... 2 2. Website structure 2 … 2 3. Access platform 3 3.1 Introductory text 3 3.2 PRISMAP guide for applicants 3 3.2.1 Eligibility, rules and conditions 3 3.2.2 Dissemination and reporting 4 3.2.3 Coverage 4 3.2.4 Transportation 5 3.2.5 Ethics 5 3.2.6 PRISMAP user project agreement 5 3.2.7 Application form 5 4. Conclusions 6
Deliverable D1.1 v Abbreviations, Participant short names ... Abbreviations … GA Grant Agreement H2020 The European Union’s Horizon 2020 research and innovation programme (Radio)isotope/ nuclide (Radio)isotopes are (radio)nuclides of the same element1 TNA Transnational access activity UF User Forum UG User Group USP User Selection Panel Participant short names CERN European organization for nuclear research NPL National Physical Laboratory PSI Paul Scherrer Institut CEA Commissariat à l’énergie atomique et aux énergies alternatives IST-ID Associação do Instituto Superior Técnico para a IST-ID Investigação e Desenvolvimento DTU Danmarks Tekniske Universitet CHUV Centre hospitalier universitaire vaudois GANIL Grand Accélérateur National d’Ions Lourds SCK CEN Studiecentrum voor Kernenergie / Centre d'étude de l'énergie nucléaire ARRONAX Groupement d’intérêt public ARRONAX ESS European spallation source ERIC TUM Klinikum rechts der Isar der technischen Universität München KULeuven Katholieke Universiteit Leuven MedAustron Entwicklungsund Betriebsgesellschaft MedAustron GmbH SCIPROM SCIPROM Sàrl MUI Medizinische Universität Innsbruck ILL Institut Max von Laue - Paul Langevin JRC JRC -Joint Research CentreEuropean Commission 1 Consensus nomenclature rules for radiopharmaceutical chemistry, https://doi.org/10.1016/j.nucmedbio.2017.09.004. 47Ca and its daughter 47Sc are both radionuclides, but when named in the same phrase one would formally not use the term "radioisotopes" because they belong to two different chemical elements. However, historically the term “isotope” or “radioisotope” was often used synonymously with “radionuclide” and medical literature partially reflects this practice. Thus, also the present text may occasionally depart from the prescribed conventions for improved readability.
Deliverable D1.1 vi NCBJ Narodowe Centrum Badań Jądrowych GSI GSI Helmholtzzentrum fr Schwerionenforschung GmbH LU Latvijas Universitāte INFN Istituto Nazionale di Fisica Nucleare UiO Universitetet i Oslo
Summary ... // Keep this line in place. It is need to fix a Word-bug in the TOC. PRISMAP - The European medical isotope programme will provide access to innovative medical radionuclides and their applications by a consortium of key European infrastructures, with harmonised procedures through a single web-based access platform. This deliverable D1.1 describes the PRISMAP application procedures to grant access to the PRISMAP services provided for the preparation of radionuclides and their medical application. This document describes how the access platform will be integrated into the PRISMAP website and includes a summary text for the dedicated webpage, a description of the guide for applicants, which will be made available for download on this page, as well as of the online user application form. The guide for applicants includes an introduction to the application procedures and requirements, the selection criteria and guidance for the user application form. The user application form consists of two parts: Part A is completed through online forms and provides mainly administrative information. Part B includes a description of the proposed scientific project, to be uploaded as a pdf file. The contents and format of the application procedures incl. the user application form may evolve over time according to the feedback from consortium members, the PRISMAP User Selection Panel (USP) and the PRISMAP User Forum (UF) representing our present and future users. To complement the present D1.1, the radionuclide production and medical application service portfolios are detailed in deliverables D2.1 and D3.1, respectively. The first version of the PRISMAP website is described in deliverable D7.1. All four deliverables are due after project month 3 and will be cumulated in a more complete website soon after their submission.
Deliverable D1.1 2 1. Introduction … ... This deliverable D1.1 describes the PRISMAP application procedures to grant access to the PRISMAP services for the preparation of radionuclides and their medical application. This document includes a summary text for the dedicated page of the PRISMAP website, a description of the guide for applicants which will be made available for download on this page as well as the online User Application Form. We also describe how the information of this deliverable will be embedded in the PRISMAP website (D7.1), together with the information about our service portfolios as described in D2.1 and D3.1. 2. Website structure … The PRISMAP project aiming at building a European network for medical isotopes will use its website (D7.1) to describe the access procedures and requirements and collect user proposals applying for the production of radionuclides and/or for their medical application within one of the PRISMAP facilities. As illustrated in Figure 1, this website is divided into two parts: A first part dedicated to PRISMAP as a H2020 funded project, describing the project, its consortium, progress and achievements; as well as a second part dedicated to the services which PRISMAP provides for the production and use of medical radionuclides. Both parts can be reached via the same domain name. Different colour schemes are used for these different parts. It is envisaged that the Medical Radionuclides part will be used and further developed beyond the frame of the PRISMAP project. Already now this part of the PRISMAP website can also be reached via the domain www.medical-radionuclides.eu, which redirects to https://www.prismap.eu/radionuclides/. The Medical Radionuclides part of the website will consist of two sections: 1. An access platform through which external users will be able to apply for access to PRISMAP infrastructures and services. This platform will initially include an introductory text, a downloadable guide for applicants and an online application form. The current deliverable, D1.1, will provide this section with the information and structure necessary for users to apply for these services. This will be completed over time e.g. by summaries of all user projects and resulting publications. 2. A map of isotopes and services offered within the PRISMAP project, relevant information on medical applications and training. Initial information for this section will be provided by D2.1 and D3.1, also due after project month M03. Figure 1. PRISMAP website structure
Deliverable D1.1 3 3. Access platform The access platform will initially include an introductory text, a downloadable guide for applicants and an online user application form. 3.1 Introductory text The following introductory text to the PRISMAP access platform is suggested: PRISMAP federates a consortium of the key European intense neutron sources, isotope mass separation facilities and high-power accelerators and cyclotrons, with leading biomedical research institutes and hospitals active in the translation of the new radionuclides into medical diagnosis and treatment, in support of the medical radionuclide user community. It will create a single-entry point for a starting user community distributed amongst universities, research centres, industry and hospitals, and further receives support of leading associations and institutions in the field such as the European Association of Nuclear Medicine (EANM) and the International Atomic Energy Agency (IAEA). Our main goal is to provide a sustainable source of high purity grade new radionuclides for medicine, access to medical research laboratories able to handle these radionuclides; and thus, enable and accelerate early phase research on radiopharmaceuticals, targeted drugs for cancer, theranostics and personalised medicine, shaping the European radionuclide landmark as a gold standard. We are pleased to offer the following transnational access programme and cover related costs from the PRISMAP budget: Projects selected based on excellence by an international expert panel, the PRISMAP User Selection Panel Production and delivery of radionuclides for the approved medical research projects, excluding shipping costs Access to a selection of medical research laboratories, or selection of preclinical research techniques fully performed as a service for the approved medical research projects Travel, subsistence and local accommodation costs are NOT covered under PRISMAP. For more details about rules and conditions as well as instructions to the User Application Form please refer to the PRISMAP guide for applicants. For the submission of your user application, please move to the Submission Portal. 3.2 PRISMAP guide for applicants The PRISMAP guide for applicants is intended to explain to users how to apply for PRISMAP services. It also defines the criteria that users must meet to successfully apply for the use of these services. The document includes an introduction to the application procedures and requirements, the selection criteria and instructions for the user application form. 3.2.1 Eligibility, rules and conditions The following is a summary of the rules, conditions and eligibility governing transnational access to the infrastructures participating in PRISMAP. These rules are formulated by the PRISMAP Consortium based on the relevant provisions of the European Commission’s Grant Agreement (GA). In case of any conflict, the provisions of the GA take precedence. The Principal Scientist and the majority of the users must work in a country other than the country(ies) where the infrastructure is located (this rule applies for the entire duration of the access period). A User Group (UG) conducting their research in the country of the infrastructure is not eligible. If several