D3.1 - Interim Data Management Plan for STRONG-AYA

1 A new, in e disciplina y, mul i-s akeholde Eu opean ne wo k o imp o e heal hca e se ices, esea ch and ou comes o Adolescen s and Young Adul s. STRONG-AYA – No. 101057482 – D3.1 Deli e able Repo In e im Da a Managemen Plan o STRONG-AYA Deli e able D3.1 Sho i le : In e im Da a Managemen Plan Due da e o deli e able: 01/04/2023 Ac ual submission da e: 31/03/2023 P ojec : STRONG-AYA Lead Con ibu o Leona d WEE (Clinical Da a Science – Uni e si y Maas ich ) Email [email p o ec ed] O he Con ibu o s [WP1] Anne-Sophie Da ling on ([email p o ec ed].uk) – Uni e si y Sou hamp on [WP2] Ma ia Aguado (ma ia.aguado@eo c.o g) - EORTC [WP2] S ephane Lejeune ([email p o ec ed]) – EORTC [WP2&3] Daniel S a k ([email p o ec ed]) – Uni e si y Leeds [WP3] And e Dekke ([email p o ec ed]) – Uni e si y Maas ich [WP3] Ba an Beusekom ([email p o ec ed] – Ne he lands Comp ehensi e Cance Cen e [WP4] No be Couspel ([email p o ec ed]) – Eu opean Cance O ganiza ion [WP5] Olga Husson ([email p o ec ed]) – Ne he lands Cance Ins i u e [WP5] Simone Hanebaum ([email protected]) – Ne he lands Cance Ins i u e Emails See a e abo emen ioned pe sons, in pa en heses. STRONG-AYA – No. 101057482 – D3.1 Due da e 01 04 2023 Deli e y da e 01 04 2023 Deli e able ype R Dissemina ion le el SEN Desc ip ion o Wo k Ve sion Da e D a ing wo k V0.1 - In e im Da a Mgm Plan V1.0 31/03/2023 Desc ip ion o Deli e able: An ini ial Da a Managemen Plan will be de eloped and upda ed o he inal deploymen nea he end o he p ojec . The Da a Managemen Plan(s) will e lec he echnology and si ua ion-speci ic needs o be add essed by he p inciples o da a p i acy by design and by de aul . I will de ine da a anonymiza ion s anda ds, minimum sa egua ds and obliga ions o he da a cus odians. In collabo a ion wi h WP2 i will de ine a STRONG-AYA in o ma ion secu i y policy. 1. Summa y (max ½ page) STRONG-AYA is a ision o an in e disciplina y, mul i-s akeholde Eu opean ecosys em u ilising widely geog aphically dispe sed da a o imp o e heal h se ices, clinical esea ch and pa ien -cen ed ou comes o 15-39 yea old pe sons wi h cance . This is a special g oup o people in heal hca e, ha expe iences age- speci ic and li es yle-speci ic issues when diagnosed wi h cance , o en wi h d as ically-al e ed quali y o li e compa ed o hei cance - ee pee s. The STRONG-AYA p ojec aces his challenge wi h an o ganiza ional s uc u e and echnological inno a ions ha can b ing oge he heal h da a abou his special g oup o people, and lea n ac ionable insigh s om his da a, all he while p o ec ing indi idual iden i ies by p inciple and by design. This in e im Da a Managemen Plan se s ou he p esen ision o decen alized da a managemen , and may be expec ed o change in ce ain de ails as he STRONG-AYA conso ium de elops and ma u es. Howe e , he co e concep s con ained he ein a e no expec ed o change signi ican ly. This documen ou lines he decen alised s o age o app op ia ely pseudonymised da a in acco dance wi h he p incipal o da a minimiza ion. This da a shall be made FAIR, bu no open due o sensi i e na u e o pe sonal, medical and li es yle in o ma ion (in spi e o pseudonymiza ion). FAIRness o he p i a e da a is a p e equisi e o compu e -con olled Fede a ed Analy ics and Fede a ed Lea ning. Fede a ed he e means he dissemina ion o summa y s a is ics and epidemiological models, wi hou he exchange o indi idual pa ien -le el da a. Las ly, he ou line o a secu e sys em in as uc u e o assu e p i acy by p inciple and STRONG-AYA – No. 101057482 – D3.1 p i acy by design is p esen ed. A inalized Da a Managemen Plan is scheduled o deli e y nea he end o he STRONG-AYA p ojec . 1 In oduc ion Gene al in oduc ion o STRONG-AYA p ojec STRONG-AYA is a ision o an in e disciplina y, mul i-s akeholde Eu opean ede a ed ecosys em o da a a ailabili y o imp o e heal h se ices, clinical esea ch and pa ien -cen ed ou comes o adolescen s and young adul s (AYAs) wi h cance (i.e., 15-39 yea s o age a i s cance diagnosis). AYAs comp ise a demog aphically di e se and clinically he e ogenous g oup ac oss he leng h and b ead h o Eu ope, due o uniquely age-speci ic and li es yle-speci ic issues, as well as d as ically al e ed quali y-o - li e compa ed o hei cance - ee pee s. The STRONG-AYA conso ium belie es ha inno a i e and pa adigm-b eaking ways o accessing da a and sha ing knowledge ac oss ins i u ional siloes is u gen ly needed o add ess heal hca e needs among his unique g oup o people. The key pilla s o he p ojec a e: (1) consensus de elopmen o a Co e Ou comes Se i.e. COS; (2) in as uc u e o collec ing, managing and enhancing AYA da a among pa icipa ing coun ies; (3) dissemina ing ou comes and da a analysis ools a he pan-Eu opean le el o imp o e pa e ns o ca e o AYAs. A ede a ed ecosys em - o decen alized da a managemen as well as enabling so wa e echnology o s akeholde s (e.g., clinicians and pa ien s) o be able o pe o m ede a ed da a analysis - was selec ed as he in ended app oach o add ess da a agmen a ion, bypass adop ion ba ie s associa ed wi h cen alized pa ien da a eposi o ies, and o be mo e easily scalable o o he cen es a e end o cu en p ojec . STRONG-AYA – No. 101057482 – D3.1 Da a managemen ha complies wi h FAIR (Findable-Accessible-In e ope able-Reusable) da a p inciples is a co ne s one o ou echnical in as uc u e. The FAIR p inciples will acco dingly be applied a pa ne , na ional and pan-Eu opean le els o da a, and subsequen ly digi al a e ac s gene a ed (e.g., so wa e, publica ions, epo s) om he p ojec wo k. A u he echnological co ne s one o he p ojec shall be ede a ed analy ics, i.e. pe o ming s a is ical analyses and summa y isualiza ions o da a bu all he da a s ays locally wi hin he o iginal ins i u ion. The emphasis is ha indi idual pa ien -le el da a will no lea e he da a-holding ins i u ion. STRONG-AYA suppo s ede a ed lea ning such ha p ognos ic and p edic i e (epidemiological) models can be de eloped and alida ed, also wi hou sha ing indi idual pa ien -le el da a be ween ins i u ions. Fede a ed analy ics (and ede a ed lea ning) ha use geog aphically dispe sed FAIR da a equi es secu e web connec i i y in as uc u e ha is upg adeable, main ained and moni o ed agains ex e nal a acks. Use - acing web in e aces hos ing applica ions app o ed by he STRONG-AYA conso ium will be made a ailable, so dis inc use s will each ha e di e en ia ed pe missions and ge access o analy ical/lea ning ools. Scope o Da a Managemen Plan(s) The Da a Managemen plan ou lines (1) in gene al e ms he da a used in his p ojec , (2) ha da a is p o ec ed by keeping i wi hin he da a-holding ins i u ions, (3) implemen a ion o he FAIR p inciples o make ins i u ional da a mu ually in e -ope able ac oss he STRONG-AYA conso ium and (4) a ailabili y o he da a a e he p ojec ends. Addi ionally, he e shall be a numbe o end p oduc s o STRONG-AYA om a da a managemen pe spec i e, which a e ele an o he sus ainabili y a e unding ends, and o o he simila ede a ed FAIR da a ecosys em ini ia i es such as he Eu opean Heal h Da a Spaces. The end p oduc s include: 1) An in o ma ion model (i.e. umb ella p o ocol), ha de ines he Co e Ou comes Se (COS) o be ob ained by pa ne s in he STRONG-AYA communi y. 2) A FAIR implemen a ion p o ile ha desc ibes how he ins i u ion-speci ic da a schema is mapped a pos e io i o a uni e sal e minology and axonomic model o he o e -a ching COS. 3) Open-sou ce so wa e, enginee ing know-how, and e e ence implemen a ions o he a o emen ioned, including syn he ic da a which helps u u e pa ne s se up hei own FAIR da a eposi o ies acco ding o he in o ma ion model (1) and FAIR implemen a ion p o iles (2). 4) Open-sou ce so wa e eposi o y o ede a ed analy ics (FAIR models) and e e ence implemen a ion amewo ks o new conso ia (FAIR se ices) ha we e used in STRONG-AYA so ha o he use s can apply he STRONG-AYA in as uc u e o hei own p ojec s. Complemen a y documen a ion This documen is he ea e e e ed o as he Da a Managemen Plan, o he DMP in sho . The DMP is in ended o he use o pa ne s o he STRONG-AYA P ojec ( e e ence numbe 101057482). The pa ne s a e de ined in he Gene al Ag eemen (execu ed on 18 May 2022, i s amendmen da ed TBC), ha e execu ed he Conso ium Ag eemen (20 Decembe 2022), and whose asks a e de ailed in he p ojec scope o wo k in he a o emen ioned Gene al Ag eemen . The DMP is o be used complemen a ily wi h he STRONG-AYA (go e nance, legal and ope a ional) ecosys em documen – see Deli e able 2.1. STRONG-AYA – No. 101057482 – D3.1 The DMP is o be used complemen a ily wi h he STRONG-AYA echnical bluep in documen – see Deli e able D3.3. The DMP is o be used complemen a ily wi h he STRONG-AYA eco d o p ocessing ac i i y (ROPA) and da a p o ec ion impac assessmen (DPIA) – see Deli e able 2.2. The de ini ions used in he DMP aligns o e minologies in he o hcoming STRONG-AYA join da a con olle ship and da a p ocessing ag eemen . 2 P ocedu e The p elimina y COS Da a i ems we e de eloped by consensus among he pa ne s in Wo k Package 1. A gene al wish-lis o da a domains we e su eyed among pa icipa ing clinical ins i u ions and cance egis ies. P agma ically, a mo e de ailed lis o da a ields we e de eloped as al eady ou inely collec ed, and would be easible o collec in u u e. The COS is in ended o g ow and scale in u u e, as pa ne s jou ney u he in o his p ojec . Wi h Wo k Package 2, su eys and uns uc u ed in e iews we e conduc ed in o de o unde s and he exis ing da a lows wi hin pa ne ins i u ions, and po en ial o scaling up in u u e. This in o ms he e alua ion o p ocessing ac i i ies and da a p o ec ion impac assessmen . This wo k is ongoing. The p incipal wo k o ecosys em desc ip ion and echnical bluep in de elopmen was ca ied ou by easibili y su eys and uns uc u ed in e iews among pa ne s, and d awing hea ily om expe ise in success ul ede a ed lea ning p ojec s led by IKNL and Uni e si y Maas ich . This wo k is ongoing, howe e he baseline echnical bluep in will be made a ailable online as a an “agile” documen and hus inco po a es ex a unc ionali y as his p ojec p og esses. Engagemen wi h a wide ne wo k o cu en and u u e s akeholde s is he wo k o WP4, and is ongoing. The engagemen s a e essen ial o unde s and he needs o he u u e da a con ibu o s and po en ial da a use s o he ede a ed ecosys em, hus he echnical bluep in and he DMP will e ol e hand in hand. This in e im DMP was d a ed based a ound he EU Ho izon2020 DMP empla e and he guidance documen a ion om he in e na ional GO-FAIR Ini ia i e. The co-con ibu o s ha e e iewed his DMP documen , and ag ee on his as an in e im DMP, in o de p oceed u he wi h ecosys em design and echnical de elopmen , leading owa ds a inalized DMP a he end o he p ojec as p omised. 3 In e im Da a Managemen Plan Co e Ou comes Da a 3.1.1 S a emen o in ended pu pose o collec ion The s a emen o in ended pu pose has been based on ex om he STRONG-AYA (go e nance, legal and ope a ional) ecosys em epo – Deli e able 2.1. Adolescen s and young adul s (i.e., AYAs) wi h cance o m a unique g oup; hey ace age-speci ic issues (e.g. in e ili y, unemploymen , inancial p oblems) and dec eased quali y o li e due o cance and i s ea men . Unlike dedica ed heal hca e se ices and clinical ials o paedia ic cance pa ien s, AYA-speci ic heal hca e se ices emain sca ce and p ac ice is he e ogeneous ac oss Eu ope. AYAs, who also a e a he e y co e o socie y and he economy, need access o e idence-based age-app op ia e and high-quali y dedica ed heal hca e. STRONG-AYA – No. 101057482 – D3.1 AYA ca e and esea ch will bene i om collec ion and pooling o pa ien -cen ed da a and collabo a ion among a wide spec um o s akeholde s: pa ien s, heal hca e p o essionals, scien is s, and policymake s. The compa isons and desc ip i e analyses ca ied ou will be used o imp o e cance ca e and ea men a he policy, o ganisa ional, se ice and in e pe sonal le el. 3.1.2 Types o da a collec ed The p ojec in ends o make use o wide- anging pa ien da a, ine de ails pending he inal COS epo , in he ollowing gene al domains. This p elimina y lis has been p o ided as a s a ing poin o he conso ium o de elop and ex end and scale up; i is no o be aken as he inal and de ini i e decla a ion o a inalized COS da a se . De e minan s and case mix ac o s - Tumou /disease pheno ype (such as s aging, si e and ype o cance ) - T ea men (s) ecei ed (such as su ge y, chemo he apy, adio he apy, immuno he apy o combina ions he eo ) - Biological sex and sel -de ined gende p onouns - Age a cance diagnosis - Social de e minan s (such as socioeconomic g ading, e hnici y/cul u al backg ound, highes educa ion a ained, employmen ca ego y, domes ic s a us, i he e a e dependen pe sons) - Body composi ion (such as body mass index) - P e-exis ing medical condi ions - Risk s a i ica ion - Use o diagnos ic imaging o diagnosis and disease quan i ica ion Physiological and clinical ou comes Quali y o li e ou comes and impac s on ac i i ies associa ed wi h daily li ing - Physical unc ioning, Social unc ioning, Role unc ioning, Emo ional unc ioning, Cogni i e unc ioning - Global quali y o li e - Pe cei ed heal h s a us - Pe cep ions o deli e y o ca e (Sa is ac ion/pa ien p e e ence, Accep abili y and a ailabili y o ca e, Adhe ence/ compliance, Wi hd awal om ea men , App op ia eness o ea men ) - P ocess, implemen a ion, and se ice ou comes Heal h sys em esou ce u iliza ion pa e n - Economic/Financial ha dship - T ea men - ela ed inju y/ oxici y - Insu ance s a us - Hospi aliza ion and pos - ea men heal h ca e u iliza ion (e.g. ea ed as adul o by a paedia ic specialis ) - Need o u he in e en ion a e cance in e en ion - Socie al bu den/ca e bu den - Medical ad e se e en s and a e -e ec s Mo ali y - All-cause mo ali y STRONG-AYA – No. 101057482 – D3.1 3.1.3 Re-use o exis ing da a wi hin his p ojec In STRONG-AYA, p ima y eliance shall be placed on da a ob ained du ing ou ine cance ca e and s anda d clinical p ocedu es (i.e., eal-wo ld da a) supplemen ed by da a ex ac ions om p e iously concluded clinical ials ( ha migh be ei he obse a ional o expe imen al in na u e). This means STRONG-AYA is p incipally a DATA SECONDARY USE ype o s udy. App op ia e da a pe aining o be abo emen ioned COS gene al domains shall be sou ced by pa ne ins i u ions om wi hin hei own clinical en i onmen (such as cha audi s, elec onic heal h eco ds, quan i a i e ques ionnai es), heal hca e p o ide s in hei ca e ne wo k and om hei adjacen na ional/ egional/hospi al-based cance egis ies. The quali y o li e domain in he abo emen ioned da a is in ended o be sou ced ia pa ien - epo ed in o ma ion. The COS domains and da a ields collec ed may be ex ended in scope and scale wi hin he p ojec ; he DMP shall be modi ied acco dingly in u u e e sions o cap u e such changes in scope and scale o da a ga he ing by p ojec pa ne s. One o he in en ions in STRONG-AYA is o suppo he c ea ion, ex ension and sus ainabili y o ins i u ional wo k lows o collec high quali y COS da a well in o he o eseeable u u e. This means ha u u e da a collec ion i ems need o become implemen ed in o ou ine clinical ca e as well as in s anda d ollow-up, and changes also need o be implemen ed in o epo ing p o ocols o cance egis ies. 3.1.4 PROMs as a special ca ego y o da a collec ion In heal hca e, he collec ion and u iliza ion o Pa ien Repo ed Ou come Measu es i.e. PROMs is an e e inc easingly impo an sou ce o da a abou quali y o li e, impac s on ac i i ies ela ed o daily li ing and pe cep ions o he u ili y o ca e. Howe e , sys ema ic collec ion o PROMs among he STRONG-AYA pa ne s is p esen ly highly he e ogenous, and only some i ems a e being eco ded sys ema ically and in all places. The collec ion and u iliza ion o PROMs shall be an impo an aspec o STRONG-AYA. Some pa ne s ha e digi al PROMs acquisi ion sys ems ha con ac he pa ien and solici elec onic esponses o PROMs-based quan i a i e su eys. Some pa ne s do no ha e any PROMs acquisi ion sys ems a all, and o he pa ne s ely on pape o ms which hen ha e o be collec ed o digi iza ion. Fu he mo e, pa ien engagemen will be c ucial, as he AYA pa ien communi y will end up being he d i e s o he design o PROMs collec ion and PROMs u iliza ion. The STRONG-AYA p ojec is commi ed o ha moniza ion o elec onic PROMs da a collec ion and i s in eg a ion wi h as many exis ing sys ems as possible, bu he exac echnical design o such an in as uc u e hinges upon he selec ion o key u iliza ion cases which hus equi es ex ensi e pa ien engagemen ; his is he p incipal wo k o Wo k Package 4. The PROMs u iliza ion design shall no iola e he o e all p inciples laid ou in he STRONG-AYA ision, bu de ailed da a managemen planning pe aining speci ically o PROMs emains impossible a he p esen ime. A comple e PROMs u iliza ion plan will be included in he de ini i e e sion o his DMP o be deli e ed a end o p ojec . 3.1.5 Da a sou ces Re ospec i ely collec ed and eal-wo ld da a Clinical case mix ac o s, ea men /in e en ion in o ma ion, diagnoses, physiological ou comes, clinical ollow-up and mo ali y will p edominan ly be sou ced om elec onic medical heal h eco ds main ained by he pa icipa ing ins i u ion and/o by ex ac ion om al eady-closed clinical ials. Social de e minan s o ca e, quali y o li e, impac s on ac i i ies o daily li ing and heal h sys em u iliza ion a e in ended o be ex ac ed om cance egis y da abases and supplemen ed by ex ac ion om al eady- closed clinical ials. STRONG-AYA – No. 101057482 – D3.1 P ospec i ely collec ed da a Fo u u e, expanded and mo e de ini i e e sions o COS da a ields, he abo emen ioned ins i u ional elec onic heal h eco ds and cance egis ies need o be expanded and upda ed. This is an ope a ional ques ion ha is impossible o answe a he e y ou se he p ojec , howe e discussions a e ongoing wi h pa ne ins i u ions o ind ou wha will be easible o u u e da a collec ion. Gene al and speci ic conside a ions o he da a The Decla a ion o Helsinki de ines “ ulne able g oups and indi iduals“ as hose ha ing an inc eased likelihood o being w onged o o incu ing addi ional ha m – in he con ex o medical esea ch. Gene ally speaking, ulne able indi iduals o popula ions a e hose whose decision making capaci y and abili y o exe cise and p o ec hei igh s is es ic ed due o hei men al, social, economic o e hnical s a us, age o heal h condi ion o , in o he wo ds, hose who in one o mo e ways a e a isk o being ha med h ough he conduc o esea ch. The a ge popula ion o STRONG-AYA o e laps wi h subjec s ha would be commonly deemed as “ ulne able indi iduals”, speci ically pe sons wi h incu able diseases, pe sons who a e unemployed o impo e ished, pe sons om e hnic mino i y g oups, and mino s. The inclusion o such subjec s’ da a equi es ca e ul conside a ions in e ms o he esea ch ac i i y being ca ied ou as well as p o ec ion o iden i iable pe sonal cha ac e is ics. The in-dep h de elopmen o go e nance p inciples o STRONG AYA will be comple ed by he end o he i s yea o he p ojec . This is one o he p incipal ou pu s esul ing om Wo k Package 2. An in en o y o ele an exis ing e hical and go e nance codes and guidelines al eady p esen in he a ious pa ne ins i u ions will esul in he de elopmen o he p ojec ’s e hical and legal guidelines and amewo k, and his shall align p inciples om he di e en STRONG AYA pa ne s as well as ele an EU go e nance and e hics p inciples (such as he ‘Eu opean E hical P inciples o Digi al Heal h’ 2022), and wi h he key p inciples laid ou in he Gene al Da a P o ec ion Regula ions (GDPR) wi h i s ele an amendmen s. The ollowing is based on ex om he STRONG-AYA (go e nance, legal and ope a ional) ecosys em epo – Deli e able 2.1. The a o emen ioned p inciples shall include bu a e no s ic ly limi ed o: - law ulness, ai ness and anspa ency: da a shall be p ocessed law ully, ai ly and in a anspa en manne in ela ion o he da a subjec ; - limi a ion o pu pose: da a shall be collec ed o he speci ied, explici and legi ima e pu poses and no be u he p ocessed in a manne ha is incompa ible wi h hose pu poses; u he p ocessing o a chi ing pu poses in he public in e es , scien i ic o his o ical esea ch pu poses o s a is ical pu poses shall, in acco dance wi h A icle 89(1), no be conside ed o be incompa ible wi h he ini ial pu poses; - da a minimisa ion: da a shall be adequa e, ele an and limi ed o wha is necessa y in ela ion o he pu poses o which hey a e p ocessed; - accu acy: da a shall be accu a e and, whe e necessa y, kep up o da e; e e y easonable s ep mus be aken o ensu e ha pe sonal da a ha a e inaccu a e, ha ing ega d o he pu poses o which hey a e p ocessed, a e e ased o ec i ied wi hou delay; - limi a ion on s o age: da a shall be kep in a o m which pe mi s iden i ica ion o da a subjec s o no longe han is necessa y o he pu poses o which he pe sonal da a a e p ocessed; pe sonal da a may be s o ed o longe pe iods inso a as he pe sonal da a will be p ocessed solely o a chi ing pu poses in he public in e es , scien i ic o his o ical esea ch pu poses o s a is ical pu poses in acco dance wi h A icle 89(1) subjec o implemen a ion o he app op ia e echnical and o ganisa ional measu es equi ed by his Regula ion in o de o sa egua d he igh s and eedoms o he da a subjec ; STRONG-AYA – No. 101057482 – D3.1 • So wa e ools (e.g., FAIRi ca ion ools, syn he ic da a examples, ede a ed in as uc u e and ede a ed analysis/lea ning algo i hms) will become an in eg al pa o an es ablished and well- managed open-sou ce se o p oduc s, so as o maximise e-usabili y. R1.2. (Me a)da a a e associa ed wi h de ailed p o enance • All elemen s associa ed wi h a URL o URI a e e sion con olled. • Da a p o enance is moni o ed by he da a-owning ins i u ions. Inso a as possible, ins i u ional da a wo k lows a e sc ip ed and au oma ed and documen ed in a u u e pa ne -speci ic da a wo k lows epo . • O e all esponsibili y o da a li ecycle managemen (e.g., s o age, back-ups, dele ions and in eg i y o unde lying da a sou ces) lies wi h he da a p o ide s, and FAIR-speci ic ooling o upda e, add and dep eca e da a will be p o ided o pa ne s. R1.3. (Me a)da a mee domain- ele an communi y s anda ds • Implemen a ion o RDF and Seman ic Web mee s domain-speci ic s anda ds whe e e hese al eady exis , pa icula ly o da a. • All easonable s eps a e aken o be as FAIR as possible whosoe e es ablished communi y s anda ds do no exis . 3.5.5 Da a Loss Mi iga ion Pa ne ins i u ions ha hos da a, in he ede a ed analysis/ ede a ed lea ning pa adigm, keep hei own da a “on p emise” i.e., he COS da a i ems a e placed in a secu ed esea ch and compu a ional en i onmen con olled by he pa ne ins i u ion hemsel es. The e will be no ans e o pa ien -le el da a (in any o m) om one STRONG-AYA pa ne o ano he , o he pu pose o he kinds o analyses pe mi ed in he STRONG-AYA amewo k. The echnical bluep in documen – see Deli e able 3.3 – equi es ha on-p emise COS da a shall be pseudonymized (no na i e ins i u ional iden i ie s o equi alen s o social secu i y numbe s a e allowed), minimized (supe luous in o ma ion ha is no needed di ec ly o analysis such as bi hda es and pos codes a e no allowed) and ou inely backed-up as pe he ins i u ion’s own s anda d ope a ing p ocedu e pe aining o in o ma ion echnology de ices. In e en o ca as ophic loss o he COS da a and i s back-up copy, o wha e e eason, i mus be no ed ha he o iginal da a exis s in he p ima y sou ce sys ems such as elec onic hospi al eco ds, clinical ials a chi es and he cance egis ies. Al hough ex emely incon enien , he COS da a ex ac ion p ocedu es pu in place by he pa ne ins i u ions ha ead om he p ima y da a sou ces would be au oma ed o he maximum ex en possible, he e o e i may be e-done om sc a ch i uly necessa y. The likelihood o all sys ems ailing a he same ime would be e y low, and would sugges a highe p io i y c isis a he immedia e hand han he issue o eco e ing p ojec da a. The COS da a will be p ese ed on-p emise by he ins i u ions, o a leas he du a ion o he STRONG-AYA p ojec , as well as beyond he e m o he STRONG-AYA p ojec as de ined in he legal, go e nance and business ope a ions amewo k. 3.5.6 FAIR so wa e STRONG-AYA will ake all easonable s eps o make he so wa e in he p ojec o be as OPEN and FAIR as possible. The so wa e esul ing om he execu ion o his p ojec includes : STRONG-AYA – No. 101057482 – D3.1 - Fu u e e sions o Van age6 in as uc u e o ede a ed analysis and ede a ed lea ning - Code o pe o ming ede a ed da a analysis and ede a ed epidemiological modelling - So wa e ools o making s uc u ed clinical da a FAIR - In e ac i e dashboa ds o isualiza ion o summa y s a is ics - Web-based applica ions o de eloping and alida ing epidemiological models in a ede a ed ecosys em Making his so wa e FAIR shall include (bu no exclusi ely limi ed o) he ollowing : - P og amming code will be open sou ce and open access ia a widely-used public so wa e eposi o y such as Gi Hub, along wi h ich desc ip i e ex in o ming he in ended use how he so wa e shall be ins alled and ope a ed; - Pe sis en uni e sal esou ce loca o links (URLs) o he so wa e eposi o ies will always be gi en in publica ions and dissemina ions pe aining o i s use in STRONG-AYA esul s; - The esea ch esul s ha ci e he so wa e eposi o y URLs will hemsel es ha e pe sis en Digi al Objec Iden i ie s (DOIs) ha will be publicly sea chable and indable, and he esea ch esul s ( o he maximum ex en possible) will be published as open access documen s; - The p og amming code shall p incipally be in a widely-unde s ood compu e language such as Py hon, Ja a o C, o a ma hema ical sc ip ing language such as R, and u he mo e each eposi o y shall con ain links o so wa e lib a y dependencies (such as a equi emen s. x ile in Py hon) o assis ep oducibili y and e-usabili y; - Re-use o he so wa e will be widely encou aged using licensing condi ions such as C ea i e Commons By A ibu ion (wi h o wi hou Sha e-Alike op ion), he GNU Public so wa e license, and o he such simila licenses ha a e widely used by he open-sou ce so wa e communi y. In addi ion o he abo e s eps, any epidemiological models de eloped and alida ed in he STRONG-AYA p ojec shall be documen ed (along wi h i s pe sis en iden i ie s and URLs) wi h he AIME (A i icial In elligence in bioMEdical esea ch) egis y o added anspa ency - h ps://aime- egis y.o g/. The models esul ing om STRONG-AYA will also be con ibu ed o he newly s a ed FAIRmodels p ojec (h ps:// ai models.o g/) which shall hold ich me ada a on he ype o da a on which he model has been ained on, how he model was de eloped and he an icipa ed limi a ions o he model’s scope o use. 3.5.7 FAIR se ices In ou case, “se ices” e e o he ope a ional know-how o c ea ing a conso ium a ound a ede a ed da a ecosys em pa adigm, which includes: - A o mal conso ium ag eemen ha de ines he gene al igh s, oles and du ies pe aining o conso ium membe ship; - A go e nance and ope a ions amewo k ha de ines he wo k o he conso ium, including i s p ocess o legal e iew and e hical e iew o wha he conso ium may (and may no ) do wi h he collec ed da a, as well as he humanis ic alues (e.g. p inciples o pa ien empowe men ) guiding i s conduc ; - A echnology bluep in de ining he ha dwa e and so wa e equi emen s ha cons i u e he echnical pa s o he ede a ed in as uc u e; - A se o legal mechanisms, such as a join da a con olle ship ag eemen and an in as uc u e use ag eemen wi h hi d-pa y se ice p o ide s, ha a e necessa y o allow ede a ed lea ning/ ede a ed analysis o be pe o med. - An in o ma ion model (schema) including a axonomy/lexicon/ e minology de ining o he STRONG- AYA COS i ems, bu wi hou he da a i sel . STRONG-AYA – No. 101057482 – D3.1 STRONG-AYA makes he abo e se ices open ( o he maximum ex en possible) and FAIR in he ollowing manne : - Whe e app op ia e, he a o emen ioned ins umen s shall ha e names, add esses and ins i u ions and o he po en ially iden i iable and/o con iden ial in o ma ion edac ed, such ha he esul ing documen will be made openly accessible (wi h publicly accessible URL) as a empla e o u u e collabo a ions; - Each o he abo emen ioned documen s will be egis e ed wi h a pe sis en DOI, and he en i e package o documen s comp ising he STRONG-AYA se ices will be lis ed on a publicly-sea chable FAIR objec s ca alogue (such as Zenodo); - The FAIR ca alogue en y shall include ich desc ip ions abou hese se ices, and hese desc ip ions shall emain in he FAIR eposi o y e en i he documen s hemsel es a e aken o line; - Re-use o he se ices as empla es will be co e ed by a pe missi e open access license o be selec ed by he conso ium a he end o he p ojec . 3.5.8 Pos -P ojec Da a Sus ainabili y Da a in he COS p ojec is made FAIR as a condi ion o i s use du ing he p ojec , so he e a e no special cos s o make da a FAIR a e he end o he p ojec . As s a ed abo e, one o he in en ions in STRONG-AYA is o enable c ea ion, ex ension and sus ainabili y o ins i u ional wo k lows o collec high quali y COS da a well in o he o eseeable u u e and his necessa ily implies ools o making he da a FAIR on-p emises. Since he da a s ays wi hin he ins i u ion ha con ibu es he da a, STRONG-AYA me hodology mus in eg a e wi h exis ing da a managemen p ocedu es as well as da a managemen esponsibili ies ha al eady exis wi hin pa ne ins i u ions. As he p ojec , STRONG-AYA is esponsibili y o he go e nance, ope a ion and pa ien igh s p o ec ion wi hin he ede a ion in as uc u e. Cos s o long e m ope a ion and p ese a ion o he ede a ion in as uc u e is pa o he go e nance and business ope a ion plan o he en i e conso ium. Cos s o long- e m ope a ion and p ese a ion o he COS da a wi hin he pa icipa ing ins i u ions will be bo ne di ec ly by ha ins i u ion i sel . Cos s o he ongoing deli e y o he AI echnology will ha e o be bo ne by he conso ium as a whole, as hese echnologies pe mea e u he in o ou ine applica ion. Howe e , desc ibing he means by which hese o ganisa ions migh inance o o he wise sha e cos s wi h he conso ium o he main enance o hei COS da a will be a alid opic o he go e nance and business ope a ion plan. 4 Conclusion This deli e able epo consis s o an in e im Da a Managemen Plan ha is adequa ely de ailed o ac as a empo a y oadmap o u he de elopmen and e olu ion o he STRONG-AYA p ojec . I will be expec ed ha ongoing consul a ions be ween wo k packages and wi h s akeholde s will p o ide deepe de ail in ce ain sec ions o his epo , as he p ojec i sel akes inc easingly conc e e shape o e he coming yea s. This Da a Managemen Plan cap u es he cu en design and implemen a ion plan o he echnology and si ua ion-speci ic equi emen s o he p ojec , whe esoe e i in e sec s wi h da a p i acy needs o indi iduals. A inalized Da a Managemen Plan has been p omised as a u he deli e able nea he end o he p ojec . Reposi o y o p ima y da a (annex) No Applicable.