Standardised access procedures

Deliverable D1.2 Standardised access procedures 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 D1.2 2 Project Acronym PRISMAP Project Title The European medical radionuclide programme: Production of high purity radionuclides 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 M24, extended to M36 Date of delivery M36 Lead partner SCK CEN Contributing partners ARRONAX, CERN, SCIPROM, MRI TUM, CHUV, ILL, PSI Authors Ruth Vreys (SCK CEN), Charlotte Duchemin (CERN), Ferid Haddad (ARRONAX) David Viertl (CHUV), Calogero D’Alessandria (TUM), Zeynep Talip (PSI), Ulli Köster (ILL) Reviewer Kirsten Leufgen (SCIPROM) Point of Contact Ruth Vreys Institution SCK CEN E-mail [email protected] Phone +32 14 33 27 22 © PRISMAP 2021. This work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License. Deliverable D1.2 3 Revision History Version Date Author Comment 0.1 26.03.2024 Lead: Ruth Vreys Charlotte Duchemin, Ferid Haddad, David Viertl, Calogero D’Alessandria, Zeynep Talip, Ulli Köster Final draft 0.2 02.04.2024 Kirsten Leufgen Consortium internal review 0.3 18.04.2024 Ruth Vreys Response to internal review Revision and completion according to PRISMAP style and editing guidelines 0.4 22.04.2024 Véronique Gobry Review and formatting 0. 5 23.04.2024 Kirsten Leufgen, Thierry Stora, Final revisions. Version for review by the PRISMAP General Assembly 0.6 24.04.2024 General Assembly General Assembly review 28.04.2024 Thierry Stora Review by the coordinator 0.7 30.04.2024 Ruth Vreys, Charlotte Duchemin Implementation of the suggestions proposed by the General Assembly 1.0 30.04.2024 Kirsten Leufgen Final version, approved by the General Assembly Deliverable D1.2 4 Contents Abbreviations, Participant short names 6 Abbreviations 6 Participant short names 7 Summary 8 1. Introduction 9 1.1 Standardisation and harmonisation within PRISMAP 9 1.2 Scope of deliverable D1.2 9 2. PRISMAP access 9 2.1 Access rules 10 2.1.1 General conditions 10 2.1.2 Dissemination rules 11 2.1.3 Ethics regulations 11 2.2 Access process 12 3. User Agreement 14 4. User Project Report 15 5. PRISMAP call optimisations 15 6. Lessons learned 16 7. Recommended improvements 18 7.1 Access process 18 7.2 User Agreement 19 7.3 PRISMAP organisation 19 Conclusions 20 Annex 1 User Agreement 21 1. Purpose and scope 22 2. General conditions 22 2.1 Dissemination rules 23 2.2 Ethics regulations 23 3. Specific conditions 24 3.1 Delivery of radionuclides 24 3.2 Use of radionuclides 24 3.3 Intellectual Property 24 Deliverable D1.2 5 3.4 Liability 24 3.5 Payment of Fees 24 3.6 Contact persons 24 4. Applicable law and settlement of disputes 25 5. Duration 25 Annex 2 Specific access conditions of the PRISMAP facilities 27 Option 1: ARRONAX 27 Use of ARRONAX Research Facilities and Services 27 Admission 27 Safety regulations 27 Good laboratory practice 27 Option 2: CERN 28 Use of CERN Research Facilities and Services 28 Admission 28 Use 28 Medical Insurance 28 Option 8 : SCK CEN 35 Use of SCK CEN NURA research facilities and services 35 Access 35 Use of NURA research facility 35 Option 9: MRI TUM 36 Annex 3 User Project Report 40 Annex 4 PSI PRISMAP User Information 43 Deliverable D1.2 6 Abbreviations, Participant short names ... Abbreviations … ALARA As Low As Reasonably Achievable FAQ Frequently Asked Questions GCP Good Clinical Practice GLP Good Laboratory Practice GMP Good Manufacturing Practice NA Networking Activity NDA Non-Disclosure Agreement PRISMAP European Medical radionuclide Program SME Small and Medium-sized Enterprise TNA Transnational Access Activity USP User Selection Panel WP Work Package Deliverable D1.2 7 Participant short names CERN European organisation 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 NCBJ Narodowe Centrum Badań Jądrowych GSI GSI Helmholtzzentrum für 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. Radionuclides can be produced at different facilities such as research reactors or accelerators, followed by subsequent purification steps, e.g., in adequate radiochemical facilities. However, often there was no standardised way for interested users to receive (“access”) such radionuclides or services. Also, transnational access to (bio)medical research facilities is very challenging as rules and requirements related to radioprotection, preclinical and clinical studies often vary significantly from one country to another. PRISMAP, the European medical radionuclide programme, brings together key production facilities (WP2TNA2) and leading medical research facilities (WP3-TNA3) across Europe. These partners will make part of their facilities or the services provided by these available via PRISMAP. As such, the PRISMAP consortium can provide a sustainable source of high purity grade new radionuclides as well as access to translational research centres that can operate with these radionuclides. One of PRISMAP’s objectives is to develop a common web interface and entry port for the starting European nuclear medicine research community. WP1-TNA1 has developed a PRISMAP public website where the available radionuclides, the production facilities, and the translational medical research facilities with their services are presented. Access to these PRISMAP services is organised via PRISMAP calls for user projects. Individuals, groups and organisations are invited to submit a project application using the online access platform. Four calls for projects have been launched since the beginning of PRISMAP. Over the years, several adjustments have been made to the application procedure. Optimising this process is crucial for enhancing efficiency, reducing complexities, and ensuring a more streamlined and accessible user experience. The objective of the deliverable D1.2.’Standardised access procedures’ is to establish a common PRISMAP access process by standardising the access procedures for all PRISMAP production facilities (TNA2) and biomedical facilities (TNA2), ensuring a smooth and efficient user experience. This document starts with an introduction of PRISMAP and the scope of this deliverable. The second chapter specifies what PRISMAP access entails. It contains an overview of the established access rules, a flow chart that visualises the various steps involved in the access process and a concise description of all the steps. The next chapter covers the User Agreement that is to be signed once a project is selected for PRISMAP funding. As PRISMAP facilities operate under specific access conditions, this agreement describes the rights and responsibilities of both users and the assigned PRISMAP facility. By adhering to these agreed-upon terms, users can ensure a smooth and productive collaboration with PRISMAP facilities. Upon the completion of a project, users are required to submit a comprehensive User Project Report which is covered in chapter four. This report serves as a summary of their research, documenting key findings, methodologies, challenges encountered and feedback to the PRISMAP consortium. The subsequent chapter lists the PRISMAP call optimisations that have been done in between the PRISMAP calls to improve the project application. Lessons learned are captured in chapter six and include feedback from the User Selection Panel as well as the production and biomedical facilities. This section provides valuable insights into what worked well and what didn’t during the process. By understanding these lessons, areas for improvement can be identified and valuable knowledge and experiences can be transferred to future calls, preventing the repetition of past mistakes. In the final chapter recommended improvements are presented providing actionable steps to facilitate continuous progress and growth of PRISMAP. This document will be shared with the group of WP8-NA5 including present and future facilities, in order to prepare the extension of the network, involving additional emerging infrastructures. It can serve as a resource for the forthcoming development of PRISMAP+ and can also serve as a guide offering insights into the PRISMAP access process for future consortium facilities. Deliverable D1.2 9 1. Introduction 1.1 Standardisation and harmonisation within PRISMAP PRISMAP strives to create a paradigm shift in the early phase research on radiopharmaceuticals, targeted drugs for cancer, theranostics and personalised medicine. It seeks to establish a European standard for medical radionuclides to accelerate the application of novel radionuclides and the development of innovative radiopharmaceuticals, ultimately leading to better healthcare and improving the lives of European citizens. PRISMAP’s main goal is to establish a sustainable source of high purity grade “novel” radionuclides for research in nuclear medicine. To this end, PRISMAP brings together a consortium of key and upcoming major European infrastructures to become a single-entry point for all researchers active in the nuclear medicine field including SMEs, global pharma companies, nuclear centres, hospitals and universities. Access to these novel radionuclides and to translational medical research facilities where the radionuclides can be readily used, is directed through a web-based access platform on the PRISMAP public website. The establishment of this platform has been done within the web-access work package WP1-TNA1 and has been fully described in deliverable D1.1, which also includes the descriptions of both the Guide for Applicants and the online User Application Form. During the course of the project, WP1-TNA1 has strived to further harmonise and standardise the PRISMAP access process to ease the use of the services offered and improve the access procedures. This involved reviewing existing access procedures, identifying best practices based on return on experience and implementing them in a common set of access procedures. 1.2 Scope of deliverable D1.2 The overall purpose of this deliverable D1.2 is to provide a harmonised and standardised access process for the PRISMAP services (for both production and biomedical facilities). Access is meant for deliveries of radionuclides to researchers’ premises as part of WP2-TNA2 services, while it means experiments performed at or researchers hosted in biomedical institutes of WP3-TNA3. It builds further upon deliverable D1.1 ‘Web Access Platform’. This document provides an overview of the steps involved in obtaining access to the PRISMAP services. It also defines additional documents that have been developed in relation to the access process. Furthermore, improvements made to the online access application process and some lessons learned with suggestions for future calls and/or future projects are outlined. 2. PRISMAP access PRISMAP offers access to: 1. Production and delivery of high-purity grade “novel” radionuclides for medical research (WP2-TNA2). 2. Biomedical research laboratories (WP3TNA3) to a. host the applicants to perform the associated research, or b. have a selection of preclinical and clinical research techniques performed as a service, taking advantage of the available expertise. Access to these services is provided through PRISMAP calls for user projects. Individuals, groups, and organisations are invited to submit a project application via the online access platform at any time between the opening of the call and the submission deadline. In the past two years, these user calls were launched twice a year and were only open for a specific time. Deliverable D1.2 16  Promotion of WP3-TNA3 facilities After the first and second call for projects, it became apparent that there was little demand for WP3TNA3 facilities in the submitted projects. A dedicated strategy was set up by WP3-TNA3 in collaboration with WP6 and WP7 communication and dissemination to promote the use of the biomedical facilities. For example:  Grant for travel and/or accommodation (see next point on travel sponsoring)  Actively engage collaborations  mentors (further described below)  Continue to update and improve technical details and authorised radionuclides ==> to be published on the website in an easy-to-read table  Increase presence on PRISMAP User Forum and social media  Furthermore, during the access process, the USP also provides advice to users to take advantage of the availability of a WP3-TNA3 facility close to the production site in order to limit transportation losses of radioactivity.  Travel sponsoring Travel, subsistence, and local accommodation costs of users (mainly directed to PhD students) carrying out a project in one of the (bio)medical facilities may be funded by PRISMAP based on daily allowances and country coefficients up to a maximum amount.  Mentoring In the third call, several of the submitted proposals were more about getting acquainted to novel radionuclides rather than being innovative. In addition, in some cases, the quality of the submitted documents was not high enough (i.e., specific information was missing) to allow a good selection process. Finally, the return of experience of MRI TUM and DTU showed that it is easier to promote WP3-TNA3 facilities among potential users when they receive mentoring from a PRISMAP consortium member as early as possible in the application process. As written in the Description of Action (PRISMAP Grant Agreement Annex 1, Part B), WP3-TNA3 research centres can provide scientific support to future users of PRISMAP to design and organise their in vitro and in vivo experiments in coordination with WP1-TNA1, WP2-TNA2 as well as with the coordinator and the administrative and technical managers. Based on these considerations, applicants are encouraged to first contact the Help Desk to present in a few lines their project so that a PRISMAP consortium member could be proposed as a mentor for assistance during the preparation of the project. The use of a mentor is not obligatory, but a recommendation that demonstrably increases the chances of success. In Call No. 4, most of the successful user projects were supported by mentors during their preparatory phase (20 projects submitted in Call No. 4, the highest number for one call, with a success rate of 85%, the highest success rate of PRISMAP's four user calls). 6. Lessons learned  Access process The main lessons related to the access process have been acted on and have resulted in the amendments of the PRISMAP user calls as outlined in the previous chapter. For example, the technical manager and, in the last calls, the mentors provided significant help with setting the amounts of batches and activities of the radionuclides requested in the user applications. This highlights the need for contacting the help desk and assigning a mentor when needed. Both lessons have been implemented in the access process as presented in chapter 2.  User Selection Panel It became clear after the first PRISMAP user call that a pre-screening of the applications was needed before USP meetings to verify that the submitted projects are at all feasible. This task is now part of the WP1-TNA1 manager’s responsibilities. In the context of this deliverable, a short survey was sent out to the USP members to gather their feedback: Deliverable D1.2 17  Nice opportunity USP members who replied to the enquiry acknowledged the very nice opportunity to be a member of the selection panel. It allowed them to learn a lot from the project proposals and the fruitful discussion with the panel members and consortium members during the project assessments.  Selection procedure  The USP members highlighted the fact that the project assessment is challenging as the USP panel represents people with different background, all with their own way of reviewing the projects, nevertheless being subjected to the same scoring procedure. Especially the self-cut-off of 14 points has been found too rigid in respect of a rating of the type “very good” or “good”. Some USP members found the scoring fair and efficient while other USP members found it not very transparent. Some members would like to see the opportunity for projects being ‘parasitically’ possible when production batches are being produced.  The USP members were assessing the project without precise knowledge of the availability of the radionuclides and quantities with regards to what the PRISMAP TNAs can provide. It has been suggested that representatives of the requested service facilities should be involved in the selection process. Otherwise, the TNA members should be able to have access to the full proposals received before the selection process committee happens. Indeed, the USP members judged that it was sometimes difficult to balance the panel’s assessment of the quality and novelty of the science versus the practicality of being able to supply the material that the applicant has requested. Within the selection procedure the USP proposes to take into account a benefit/cost ratio in terms of PRISMAP resources.  When there are a large number of proposals to review, it is difficult for all the reviewers to read and assess all the applications in detail. Some members of the USP have suggested assigning each application to only one part of the panel in order to obtain a better and more detailed review in the case of a large number of applications. After each call, the USP provides feedback to applicants and assigned project scores are always reported very transparently. However, it has been questioned if publishing the scores actually brings any added value to the researchers. In addition, the assignment of the scores within the USP has been very rigid and has been a topic of debate as outlined in the above USP feedback. Feedback from PRISMAP facilities  Production facilities (WP2-TNA2)  It has not been clearly stated that delivery dates of the radionuclide will be decided by the production facility rather than at the request of users, as it is highly dependent on the production cycles of the selected facility. Production should still be cost efficient for the production facility. (Note that this step has now been incorporated in the Access process step 5 ‘Consultation with TNA(s)’ as proposed in Chapter 2, Figure 1.  As far as the quantity of radionuclide is concerned, there has always been a discrepancy between the production facility and the applicant, because the production facility defines the activity of the radionuclide at a given time after production, whereas the applicant defines it when (s)he starts working with the radionuclide.  Organisation of the transport of the radionuclide has been a common issue. Most candidates have no idea about prices and transport constraints. Some facilities have developed their own documents to facilitate this task. For example, at PSI, a document has been drawn up for users on what is needed (Annex 4). At ARRONAX, a list of what is needed is provided with the production schedule when the User Agreement is signed. Organising a delivery usually takes between 4 and 6 weeks to obtain all the documents. For countries outside the European Union, additional export authorisations must be requested.  It may be useful to give an estimate or example of the costs (around €2 per km in France and neighbouring countries - Belgium, Switzerland and Germany - for road transport) and logistical Deliverable D1.2 18 problems that may be encountered (e.g., customs or authorisation of transport companies that do not cover all countries).  The transnational access condition is sometimes not compatible with the ALARA principle, which is minimizing the radiological impact and risks “As Low As Reasonably Achievable”. In the case of shortlived radionuclides, it can even prevent providing “Access”, e.g. delivery, of radionuclides, thus preventing user groups in remote locations to develop their research projects while radionuclides could be made available in a local node of PRISMAP. This would be against the transnational spirit of INFRA projects, i.e. promoting access to services across Europe. We propose in this case that a different mode of – local – access be considered, for instance in a follow-up PRISMAP+ project.  Biomedical facilities (WP3-TNA3)  The wish to have one representative of each WP2-TNA2 and WP3-TNA3 facility involved in the selection process of the user projects. This way, the requested service provider can position itself and give direct feedback on what is feasible and when.  With the first user projects it became clear that sometimes the internal administration department of the facility in charge does not accept the PRISMAP documentation related to User Access. This highlighted the fact that existing facilities with fee-for-service experience will have their own access process which also needs to be followed on top of the PRISMAP Access process. (Note that the additional request of documentation or contract has been included in the proposed Access process in Chapter 2)  The user should receive information regarding the transport of the radionuclide: for some institutes the transport is arranged by the institute itself and the user only covers the costs by reimbursing the institute after shipping, for others the transport needs to be arrange directly by the user itself. In all cases the institute should provide all necessary information and assistance to the user regarding shipping and the related cost. For example, at ARRONAX, the users can decide themselves which way to proceed as sometimes it is less expensive to use non-French companies. 7. Recommended improvements In this section, suggested improvements are presented with the aim to further optimise and harmonise the PRISMAP access process. 7.1 Access process  The flowchart outlining the access process (Figure 1) may be made available on the website and included in the Guide for Applicants to provide a quick overview of the various steps in the access process.  Access Policy document: All rules and criteria related to the PRISMAP access could be collected in a single Access Policy document. At the moment these rules are stated in two separate documents (Guide for Applicants and User Agreement), however, they are not necessarily uniform across these two documents due to independent updates of the two documents. As such, having a single document would make harmonisation easier as only one document will have to be controlled. It can then be referred to in the Guide for Applicants and attached to the User Agreement. It is suggested that the access policy document should cover the following topics:  Definitions (e.g., “user group”, “user group leader”)  Criteria for application and selection  Access arrangements: here it can be stated more clearly that the transportation is at the charge of the user and that the radionuclide delivery schedule and amount will be defined by the production facility in consultation with the user. As suggested in the feedback from the production facilities in the previous chapter, it may be good to give an estimation or example of transportation costs.  Application options (see next point of improvement)  Dissemination rules  Ethics regulations Deliverable D1.2 19  Intellectual property  The Guide for Applicants and the User Agreement are aimed at users at different stages of the procedure. Those who are not selected for funding, will never use a user agreement. One could therefore also imagine including a user agreement template for information in the guide for application, for information prior to proposal submission. The actual user agreement, however, may differ dependent on the facility in charge.  Application options: Currently there is only one way to get PRISMAP access, i.e., submitting a project proposal for which access is granted based on an ‘excellence’ selection. It has been suggested that PRISMAP could also allow access for a few “test” deliveries, for example for Nuclear Medicine centres to get acquainted with innovative radionuclides. Having multiple access options would also make it possible to serve several users with one production batch which then becomes cost effective for the production facility. Since some PRISMAP facilities already offer access via multiple schemes to external users, other options could be explored. Eligibility rule: The “transnational access” rule for WP2-TNA2 facilities is counterproductive and should be replaced by the “remote access” rule that enables serving users from a geographically closer WP2-TNA2 facility to optimize the overall process.  Application form: Adjust the application form, or make separate ones, to apply for access and secondment to the (bio)medical facilities and/or request services of these facilities. It is not very clear how to fill in the current application form when requesting access to (bio)medical facilities or paid services.  User Selection Panel: The management of the USP should be adapted, depending on the services requested in the user proposal: the coordinators of WP2-TNA2 and WP3-TNA3 should liaise with the requested and involved WP2-TNA2 and WP3-TNA3 facilities early in the selection process. It is suggested that:  In case a biomedical facility is requested: The respective WP3-TNA3 representatives must be contacted early by the WP3-TNA3 coordinator.  In case a ‘first in human’ study is requested: The panel should include a person with knowledge of GMP and GCP (Good Clinical Practice). 7.2 User Agreement The User Agreement would be more comprehensive if it included provisions outlining the conditions for early closure of a project and the conditions for additional deliveries (in order to finalise the granted project). Furthermore, in section 2.2. on ethics regulation it is stated that ‘the user must sign a statement that their research complies with ethical requirements’, if applicable, this signed ethics statement should be included in the agreement as an additional annex. 7.3 PRISMAP organisation When exploring the possibility of a PRISMAP follow-up project PRISMAP+, the following suggestions have been proposed at the Consortium Meeting 6 held in November 2023 in regards to the PRISMAP organisation:  Generalise TNA2/TNA3 couples with close geographical vicinity for short lived radionuclides (<5h).  Set up ‘radionuclide based’-networks: At-211, Cu-67, Cu-64 for medium lived radionuclides (5h< <3d). Furthermore, the organisation would benefit from having an overview document with all services and their associated prices. Having a comprehensive understanding of this would be immensely beneficial for discussions pertaining to the sustainability of PRISMAP. Deliverable D1.2 20 Conclusions … Harmonising access procedures is a complex task, as it encompasses facilities at various developmental stages, ranging from newcomers to those long-established access procedures predating the start of PRISMAP. For that reason, the focus of this deliverable has been on the development of a common PRISMAP access process, which might come on top of established systems at the facilities. Optimising this process is crucial for enhancing efficiency, reducing complexities, and ensuring a more streamlined and accessible user experience. Four PRISMAP user calls been launched since the beginning of PRISMAP. The access procedure and USP selection criteria were defined at the very beginning of the project. In total, 45 projects were submitted out of which 32 were selected. Over the past two years, several refinements have been made to the access procedure, reflecting PRISMAP’s dedication to progress. From the first call to the last one, we greatly improved the administrative steps associated to the access process. For the first selected projects, it took months to get User Agreements signed whereas in the last call, two User Agreement got signed within a few weeks after USP approval. This deliverable provides a thorough overview of the PRISMAP access process, the lessons learned from the previous calls, the optimisations that have been implemented so far and provides some valuable suggestions for future improvements. This document can serve as a resource for the forthcoming development of PRISMAP+ and can also serve as a guide offering insights into the PRISMAP access process for future consortium facilities. It will be shared with WP8-NA5 in order to prepare the extension of the network, involving additional emerging infrastructures. Finally, the first user projects are close to completion and are currently supported through the final steps of the access process, i.e., submitting the User Project Report and acknowledgement of PRISMAP. All User Project Reports will be collected in the next deliverable D1.3 ‘User Projects’ which will summarise all applications, the selected projects and their main outcomes. Deliverable D1.2 21 Annex 1 User Agreement User Agreement User project identifier: User project title: Main contact of the user group: PRISMAP facility in charge: Deliverable D1.2 22 1. Purpose and scope The purpose of this User Agreement is to stipulate the legal framework for the conditions of the PRISMAP services, requested by [Name and short name of the user group], hereafter called User, represented by [Name and affiliation of the main contact of the user group] and supplied by the PRISMAP facility in charge (identified below and hereafter referred to as PRISMAP) for the User’s project [project name, project number] (the Project, as described in Annex 1 and invited for funding in Annex 2), within the framework of the European Union Horizon 2020 PRISMAP project under Grant Agreement no. 101008571, selected and approved by the PRISMAP project User Selection Panel under the general conditions stipulated in Section 2 below. Facility in charge: [Name of PRISMAP facility in charge, the one last involved in the services]. During the course of a project, it may become necessary to reallocate production or medical application tasks to different PRISMAP facilities to accommodate downtime of certain facilities or to regroup different user requests to make best use of PRISMAP resources. It is therefore not guaranteed that throughout the duration of a user project the requested services will be delivered from the same ‘facility in charge’ marked above. In the event of a change of ‘facility in charge’ during a project, users may be asked to sign an addendum to this User Agreement to cover the involvement of this other facility. 2. General conditions  To foster cross-border exchanges, the European Commission requires that access to PRISMAP services is transnational. Each user group leader and the majority of the individual users accessing the PRISMAP services must work in a country other than the country(ies) where the PRISMAP facility(ies) providing the services is/are located. The European Organisation for Nuclear Research (CERN) and the Joint Research Centre - European Commission (JRC) are international organisations and access is considered transnational from all user countries.  Access for user groups with a majority of individual users not working in an EU or associated country is limited. Furthermore, in line with measures adopted by the European Union in response to Russia’s military aggression against Ukraine (see Council Regulation (EU) No 269/20141, as amended), access is also restricted where it is sought by certain natural or legal persons, entities or bodies listed in Annex I to that Regulation (https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:02014R026920220315&from=EN).  Each user group’s individual users need to be affiliated to an academic research institution, to a nonacademic research institution, to a research hospital, or to the research department of an SME.  The Project must relate to the use of radionuclides in medical applications. The finality of the Project should be to improve the diagnosis or treatment of human disease.  The requested radionuclides and biomedical application services should be available from at least one of the PRISMAP infrastructures. Expressions of interest for innovative radionuclides that are not yet available from any of the facilities involved in the European Union Horizon 2020 PRISMAP project are also welcome to help guide the project’s development and broaden its offer.  PRISMAP shall provide the User with the PRISMAP radionuclide free of charge, as long as the total costs do not exceed the total PRISMAP budget available, and except for the radionuclide packaging and shipping costs. The User has to provide their authorisation to receive the radionuclides for the activities requested.  PRISMAP shall provide the User with free of charge access to its infrastructure, including all the logistical, technological and scientific support, as well as any specific training that is normally provided to external users of its infrastructure and their personnel.  Medical application services for the User will be reimbursed according to the normal internal rules and procedures of the facility, as long as the total costs do not exceed the total PRISMAP budget available, except for radionuclide packaging and shipping fees. Deliverable D1.2 23  Individual users present at a PRISMAP facility should abide by the normal working practices, health and safety regulations, access controls and any other regulations governing conduct or behaviour that are required by that facility and/or its infrastructure.  PRISMAP shall not be liable for, nor made party to, any claim that may arise from the use of any radionuclide it has supplied or medical facility that it has made available. The use of radionuclides and presence of individual users at a PRISMAP facility are at such users’ own risk. Neither PRISMAP nor any PRISMAP personnel accept liability for the damage or loss of any instruments, apparatus and test equipment of the User or their personnel, whether or not such damage or loss was caused directly or indirectly by PRISMAP or its personnel’s negligence. Individual users will ensure they have appropriate insurance, including personal health, accident cover and personal liability, for their activities.  All user groups must comply with the ethics and dissemination rules detailed below. 2.1 Dissemination rules Only user groups that are allowed to disseminate the results which they have generated under the project may benefit from the access, unless they are working for SMEs. For each user group project, a publishable project summary and a publishable summary of the results will be published on the European Union Horizon 2020 PRISMAP project website www.prismap.eu. The publication of results in journals or at conferences is strongly encouraged. To ensure the long-term sustainability of the PRISMAP initiative, proper recognition of the contributing facilities, their services and the involved persons is necessary. All participating PRISMAP facilities shall be acknowledged in the publication. Acknowledgement and co-authorship of PRISMAP staff members who participated in the experiment shall be considered according to the research field best practices and verified with the PRISMAP Technical Manager before any publication. The user group shall contact the PRISMAP Technical Manager 30 days prior to submission of publications or other communications of results that were obtained by making use of services provided by PRISMAP (radionuclides delivered or medical services provided). The Technical Manager will communicate to the user group the list of PRISMAP facilities and persons that have contributed to each specific project and the way this contribution must be acknowledged in the publication/communication or where co-authorship is required to reflect specific scientific contributions. Users must comply with Horizon 2020 dissemination rules (i.e. acknowledge that their work was financially supported by the European Union’s Horizon 2020 Research and Innovation Programme by including the following acknowledgement: “This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 101008571 (PRISMAP)”), and grant open access to resulting publications and related data. Dissemination shall take place only once legitimate interests regarding intellectual property have been safeguarded. A maximum publication delay of 90 days may be granted for this purpose. 2.2 Ethics regulations For projects involving medical applications, ethical issues may apply. In particular, animal studies or first-inhuman studies may be included. Before the onset of such activities, the User must fulfil all related ethical requirements and sign a statement that their research complies with these requirements. The two organisations which offer access to first-in-human studies in the frame of the PRISMAP project (MRI TUM and CHUV), both have ethics departments in place to accompany the User in this endeavour. As part of the access procedures, the related ethical requirements will be reviewed, compliance confirmed and documentation collected by the PRISMAP project’s Ethics Manager, David Viertl (CHUV), where necessary with the help of external ethics advisors. Deliverable D1.2 24 The User has read and understood PRISMAP’s ethics requirements and agrees to conduct the Project in accordance with these requirements. 3. Specific conditions 3.1 Delivery of radionuclides PRISMAP hereby undertakes to use its reasonable efforts to deliver the radionuclides by [Date], always subject to availability of PRISMAP resources and compatibility with its scientific programme as well as subject to the resources of any other facility/ies involved. Accordingly, PRISMAP reserves the right to reschedule part or all of the delivery at its discretion, taking into account its scientific programme or the availability of its key personnel. PRISMAP will arrange packaging and shipping of the radionuclides (including all export formalities as applicable), in accordance with applicable regulations. Per 3.5, below, User shall bear all related costs. Title to and risk in the radionuclides shall transfer to User upon their delivery to carrier at loading point. 3.2 Use of radionuclides User shall use the radionuclides exclusively for the agreed, non-military, purpose set out in this Project and shall ensure that its use of the radionuclides complies with all applicable laws and standards, in particular any laws concerning safety, including radiation protection and the transport and handling of dangerous goods, as well as data protection, medical ethics, testing and trials. 3.3 Intellectual Property Nothing herein shall imply a transfer of any of either party's intellectual property to the other party, and each party will retain exclusive interest in and ownership of its intellectual property developed before the execution of this User Agreement or developed outside the scope of either this Project or the PRISMAP project generally. 3.4 Liability The radionuclides are provided by PRISMAP on an as-is basis, without any warranty, express or implied, of any kind including as to quality or fitness for purpose. In particular, User understands and acknowledges that PRISMAP has not obtained any approvals or certifications for the radionuclides from any technical, safety or other authority. Any claim of quality of product or certification given by PRISMAP will be only given on behalf of that facility, not the PRISMAP consortium as a whole. Regardless of any claim of quality of product or certification, PRISMAP nonetheless accepts no liability in respect of the radionuclides or medical application services it provides, and User shall hold PRISMAP free and harmless from and indemnify them for any loss, damage or injury (i) resulting from User’s use of the radionuclides and/or the medical application services, or (ii) User’s breach of applicable laws. 3.5 Payment of Fees User bears all costs of shipping the radionuclides from PRISMAP, including, where applicable, shipping between all other facilities involved in the Project. User shall pay the corresponding invoice from PRISMAP within 30 days of receipt of the invoice on the stated account. 3.6 Contact persons Your contact persons at PRISMAP will be  Main contact: [Name], [Email]. Deliverable D1.2 25  PRISMAP Technical manager: Charlotte Duchemin, [email protected]  PRISMAP Ethics manager: David Viertl, [email protected] 4. Applicable law and settlement of disputes The law of Belgium shall govern this User Agreement. All disputes arising out of or in connection with this User Agreement, which cannot be solved amicably, shall be finally settled under the WIPO Expedited Arbitration Rules by one arbitrator appointed in accordance with the said Rules. The place of arbitration shall be Brussels if not otherwise agreed by the conflicting Parties. The award of the arbitration will be final and binding upon the Parties. 5. Duration The Project must start at the latest 18 months after selection for funding and must then be completed within the duration of the European Union Horizon 2020 PRISMAP project. This User Agreement shall expire 5 years from the date last written below. User’s obligations in clause 3.3 above shall continue in effect notwithstanding the expiration of this User Agreement. By countersigning this User Agreement, User confirms, on its and its individual users’ behalf, its acceptance of the terms and conditions set out in this User Agreement, including any “Specific Conditions” set out in Annex 3. Deliverable D1.2 32 Option 5: JRC Use of JRC-Karlsruhe Research Facilities and Services In addition to the rules and guidelines as prescribed in the PRISMAP User Agreement the following specific conditions must be met for visiting scientific personnel / users at the JRC-Karlsruhe premises Admission Prior permission is required before access to JRC-Karlsruhe is granted, ensuring that security and radiation safety standards will be respected. When ordering radionuclides, all information assuring that the right to receive and handle radioactive material is granted by regulatory authorities must be provided in due time. This also applies for information required for a secure and safe transportation to the User labs. Safety regulations All local JRC-Karlsruhe working rules and safety guidelines must be strictly adhered to. Work at the JRCKarlsruhe Lab facility may require completion of additional, local training. Deliverable D1.2 33 Option 6: NCBJ Use of NCBJ Research Facilities and Services In addition to the rules and guidelines as prescribed in the PRISMAP User Agreement, the following specific conditions must be met for visiting scientific personnel / users at the NCBJ Radioisotope Centre POLATOM: Admission Prior permission is required before access to NCBJ Radioisotope Centre POLATOM is granted, ensuring that radiation safety standards will be respected. Access to the GMP certified manufacturing laboratories will not be provided. When ordering radionuclides, all information assuring that the right to receive and handle radioactive material is granted by regulatory authorities must be provided in due time. This also applies for information required for a secure and safe transportation to the User labs. Safety regulations All local NCBJ Radioisotope Centre POLATOM working rules and safety guidelines must be strictly adhered to. Work at the NCBJ Radioisotope Centre POLATOM Lab facility may require completion of additional, local training. Good laboratory practice GLP (Good Laboratory Practice) guidelines need to be adhered at all times and in some labs GMP (Good Manufactoring Practice) guidelines must be followed. Any experiments involving the use of animals can be planned only after the permission of the local ethics committee. Deliverable D1.2 34 Option 7: PSI Use of PSI Research Facilities and Services Safety regulations You acknowledge that the radionuclides required for your experiment will be shipped to you and you will not spend time utilizing the facility’s laboratories, due to the stringent safety conditions. True information All specifications made during the proposal submission or later must be certainly true to the best of your knowledge. The samples that will be investigated during the experiment must correspond to sample declarations in the proposal. Any deviation must be declared to the local contact (Zeynep Talip and Nick van der Meulen) and the facility management well ahead of the experiment. Good scientific practice You need to respect the PSI guidelines for research integrity and good scientific practice.4 Data policy PSI has defined a data policy5 for research data according to the principles of "transparency" and "open data". It pertains to the ownership of, the curation of and access to experimental data and metadata collected and/or stored by PSI research infrastructure. Acceptance of this policy is one condition for the award of access to the PSI research infrastructures. Publication policy There are certain requirements that must be fulfilled by publications based on experiments at the different user facilities of PSI. In this case, a separate collaboration agreement must be signed between PSI and the User (or Non-Disclosure Agreement) pertaining to the experiment and publication of the data. 4 https://www.psi.ch/sites/default/files/import/integrity/DokumenteDE/Integritaet%2520in%2520der%2520Forschung_PSI_2014_2. pdf 5 https://www.psi.ch/de/science/psi-data-policy Deliverable D1.2 35 Option 8 : SCK CEN Use of SCK CEN NURA research facilities and services SCK CEN may decide to grant access to its research facilities to researchers from other entities, including from the private sector, for instance in the framework of its NURA Program, as well as European Union and similar grant schemes, to perform their own research for defined periods of time. In addition to the rules and guidelines as prescribed in the PRISMAP User Agreement the following specific SCK CEN access conditions must be met by the User and by all researchers sent by the User. Access Each individual researcher sent by the User shall complete the relevant SCK CEN registration form for access to the SCK CEN site. Further information can be found on the SCK CEN website: External contractors at SCK CEN6 In order to be authorised to perform work on the SCK CEN site, the User’s researchers are required to be appropriately informed of the applicable safety regulations and the site rules and regulations7. User shall further ensure compliance by its researchers with any instructions given to it or to them by SCK CEN and the research facility coordinator. Use of NURA research facility Use of the NURA research facility shall be exclusively for the a priori agreed, non-military, purpose. SCK CEN will give priority to the use of the research facility for the execution of its own scientific programme. The NURA research facility is made available on an “as is” basis, without any express or implied warranty, including as to the fitness of the research facility for the agreed research or the quality of any results. The User shall complete a NURA research facility Access request form in order to receive permission to access the NURA research facility, this includes receiving an SCK CEN ALARA approval. Additional ethics approval by the SCK CEN Animal Ethics Committee might also be needed. Depending on the nature of the project and the outcome of the NURA research facility Access request a separate collaboration agreement might have to be signed between SCK CEN and the User pertaining to the experiment and publication of the data. 6 https://www.sckcen.be/en/visiting-sck-cen#anchor-external-contractors-at-sck-cen 7 https://www.sckcen.be/sites/default/files/uploads/Praktisch-Contact/EN/1_Site_Regulations_for_Contractors_at_SCKCEN.pdf The term “contractor shall be read as referring to the User. Deliverable D1.2 36 Option 9: MRI TUM Copy for the user Copy for the HR department Copy for the clinic / department 37 Klinikum rechts der Isar Technische Universität München User agreement Between Klinikum rechts der Isar Ismaninger Str. 22, 81675 Munich, Germany represented by its board of directors -Klinikum-, and Mr. / Mrs., DOB residing in: Citizenship -German- -User- § 1 In the time from … to …, the user is permitted to stay in and gratuitously use the equipment of the Department of …, Director: ….., at Klinikum rechts der Isar of the Technical University of Munich. The purpose of this agreement shall be research within the scope of the Horizon 2020 PRISMAP project of the European Union under the grant agreement No. 101008571. In addition to the rules and guidelines as prescribed in the PRISMAP User Agreement, the specific conditions set out in this agreement must be met by users at Klinikum rechts der Isar. This agreement does not constitute an employment or service contract with Klinikum rechts der Isar or the Free State of Bavaria or the department chair. The agreement is conducted voluntarily on both sides. By signing this document, the user agrees that he/she pursues a salaried employment at another employer, an occupation at a scientific institution or an occupation as an independent physician or self-employed scientist. During his/her stay, the user is assigned to [user group – academic/non-academic research institution, research hospital, research department] from an organisational point of view. This agreement does not constitute an obligation to service or work performance on behalf of the user. Consequently, the user neither has a work relationship nor a relationship as a quasi-employee with the Klinikum. The user is not a vicarious agent of the Klinikum. A renumeration or other employer contribution is not granted by the Klinikum. Furthermore, this user agreement does not constitute the right to a later employment. § 2 The user is subject to the supervision and instruction of the head of the department set out in § 1. The daily operating times are to be adjusted to the usual customs at Klinikum rechts der Isar. Constraints of the usual operational process caused by the user are to be precluded by adhering to the house regulations and comparable operational provisions. Moreover, the user must take care of Copy for the user Copy for the HR department Copy for the clinic / department 38 Klinikum rechts der Isar Technische Universität München the furniture and equipment and prevent damages. In case of infringements, this user agreement can be terminated with immediate effect. The parties agree that medical or dental practice, i.e. the diagnostic or therapeutic treatment of patients shall be non-admissible. § 3 The user is informed about the fact that he/she is not covered by insurance during his/her stay at Klinikum rechts der Isar. The user ensures that he/she has taken out adequate insurance for his/her activities, including a personal health, accident and liability insurance. Neither the Klinikum, nor the Free State of Bavaria assume liability for items brought in by the user in case their destruction or damage has not been caused by gross negligence or malice. Both parties agree that the costs of damages that were culpably caused by the user must be borne by him/her. This shall be applicable in case Klinikum could legitimately claim recourse in accordance with the principles of employee liability developed by pertinent jurisdiction from its own personnel when it behaves in the same way. As the user is neither employed nor quasi-employed, he/she is informed that Klinikum will not cover any contributions towards social insurance. The user must take out adequate insurance coverage by himself/herself. § 4 This agreement can be terminated with immediate effect at any time. There is no requirement for a substantial reason. There are no claims for compensation arising from an – also premature – termination of the agreement. § 5 The user agrees to strict non-disclosure of any processes that he/she becomes aware of during the term of the agreement. Information must not be provided to third parties. This is also applicable after the end of the term of the agreement. In case the user is utilizing an own device for the analysis of clinical data, the provisions for patient data protection must be complied with. In particular, patient names must not be used in clear text, but only in anonymized or pseudo-anonymized form. Copying imaging data obtained from preclinical examinations to own digital devices (computers, USB sticks, USB drives etc.) or transferring them via the network to external servers is non-admissible. Exceptions require a dedicated written agreement. § 6 The user grants Klinikum an unlimited and exclusive right of use of copyrighted materials, in case these were created due to the research covered by this agreement. Scientific publication of contents suitable for dissemination is explicitly admissible. The dissemination rules set out in section 2.1 of the PRISMAP User Agreement are applicable to any such dissemination, and in addition, the head of department named under § 1 is to be informed in writing before publication. § 7 Changes and additions to this agreement are only effective if they are agreed upon in written form. Copy for the user Copy for the HR department Copy for the clinic / department 39 Klinikum rechts der Isar Technische Universität München Munich, Klinikum rechts der Isar Technical University of Munich Commercial Management …………………………………………. ………………………………… Thorsten Martineau Deputy of the Department of Human Resources Name of user Deliverable D1.2 40 Annex 3 User Project Report User project report … 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 D1.2 41 1. Authors 2. Context of the project (800 characters max. including spaces) 3. Results and discussion (1000 characters max. including spaces) 4. Conclusions (800 characters max. including spaces) Figure 1. An example of a figure including a caption Table 1 is an example for a table (if necessary). Table 1. Example table Column 1 Column 2 Column 3 Column 4 Column 5 1. Involvement of the PRISMAP services (600 characters max. including spaces) 2. Feedback to PRISMAP (600 characters max. including spaces) 3. Publications and other dissemination activities (conferences etc.) Appendix 1. Dissemination guidelines for user projects as agreed in the signed User Agreement Dissemination rules Only user groups that are allowed to disseminate the results which they have generated under the project may benefit from the access, unless they are working for SMEs. For each user group project, a publishable project summary and a publishable summary of the results will be published on the European Union’s Horizon 2020 PRISMAP project website www.prismap.eu. The publication of results in journals or at conferences is strongly encouraged. To ensure the long-term sustainability of the PRISMAP initiative, proper recognition of the contributing facilities, their services and the involved persons is necessary. All participating PRISMAP facilities shall be