Common use of HUS Clause in Contracts

HUS. Dataset Name BREX (for BOUNCE) Owner organization Helsinki University Hospital, Comprehensive Cancer Center Dataset description (informal meta- data) Excel file, Patient (n=573) parameters related to breast cancer biology, treatments, symptoms, patients health, lifestyle, occupation, physical condition and quality of life. The data set is retrospective and it was collected before the BOUNCE project as part of the BREX exercise intervention study. Data is essential for the premodelling of resilience. Whole dataset has longterm value since it describes well a large breast cancer population and it is partly unpublished. Formal Meta-data The description of the dataset and files is included to the dataset Standards No standards were used Origin BREX study group File Maker Pro files Language English and Finnish (numbered scales and questionaries are not translated) Size 3,5 MB Variety semi structured Type text Format sav Velocity static, no plans of updating the file Storage BOUNCE data infrastructure Quality Data is precleaned but some additional cleaning mechanisms are needed Example N/A Availability The data is only available to representatives of ICCS, FORTH and SiLo as described in the data sharing agreements Availability after the end of the project The data is only available to representatives of ICCS, FORTH and SiLo as described in the data sharing agreements during the project and one year after it. Sharing mechanisms Files already shared with relevant partners Within the BOUNCE infrastructure, the data are available through the Data Access API. How the data are going to be used during ▇▇▇▇▇▇’s lifetime Data is used according to data sharing agreements by ICCS, FORTH and SiLo. How the data are going to be used after ▇▇▇▇▇▇’s lifetime The data will be available to representatives of FORTH, ICCS and SiLo for one year as described in the data sharing agreements through the BOUNCE data repository available for further exploitation through new models that might be developed by consortium members and according to the exploitation plan developed within the consortium. Related WPs WP 3,4,5 Access rights Data is used according to data sharing agreements by ICCS, FORTH and SiLo. Anonymisation / Pseudonumisation The data is pseudonymized and all the personal identifiers are removed. The identifiers are not available for BOUNCE group they are owned by the BREX study group and coded for paper only (not electronically available). Collection workflow & methodology Data was collected during the BREX trial to CRFs in Filer Maker Pro. Ethics & GDPR Internal approval from HUS for the usage of data has been received. Since the retrospective nature of the data no consent was not required. Risk self-evaluation according the GDPR has been done. Person in charge ▇▇▇▇▇ ▇▇▇▇▇▇▇▇-▇▇▇▇▇▇▇ Additional Cost No additional cost is foreseen required to access the data or to store them.

HUS. Dataset Name BREX (for BOUNCE) PROSHUS Prospective pilot data set of HUS Owner organization Helsinki University Hospital, Comprehensive Cancer Center Dataset description (informal meta- meta-data) Excel file, Patient (n=573) parameters related BOUNCE prospective pilot data of 250 patients treated in HUS including the information collected to breast cancer biology, treatments, symptoms, patients health, lifestyle, occupation, physical condition the NOONA platform. This information includes psychosocial and quality of life. The life questionnaires and side-effects reported by the patient and medical and treatment data set is retrospective and it was collected before from the BOUNCE project as part of hospital registry by the BREX exercise intervention studytrial nurse. Data type: csv Data will be collected during the project M12-38 Data is essential needed for the premodelling modelling and validation of resilienceresilience predictor. Whole dataset data has longterm long term value since it describes well a large breast cancer population and it is partly unpublished. Formal Meta-data The description of the dataset and files Data dictionary is included to the dataset already available. Standards No standards were specific standard is used Origin BREX study group File Maker Pro files NOONA, HUS Patient record registry Uranus Language Finnish, English and Finnish (numbered scales and questionaries are not translated) Size 3,5 At most 1MB of data Variety semi Fully structured Type text Numeric mostly in CSVs Format sav csv Velocity static, no plans of updating Data are being produced in certain intervals during the file project. Storage BOUNCE data infrastructure Quality Data The quality of the data is precleaned but some additional already high. Additional cleaning mechanisms are needed (e.g. missing values handling) will be implemented by the cleaning mechanism of the BOUNCE data infrastructure. Example N/A Availability The whole dataset available under specific conditions (only for the WPs and partners who have to process the data is only available to representatives of ICCSaccording the study protocol, FORTH and SiLo as described in the data sharing agreements for confidentiality and security according to GDPR)) Availability after the end of the project The data is only whole dataset available under specific conditions (as above) for five years after the end of the project Sharing mechanisms Sent to representatives of ICCS, FORTH and SiLo as described WP3 by uploading the CSV/XLS file in the data sharing agreements during the project and one year after itsecure file repository. Sharing mechanisms Files already shared with relevant partners Within Then stored in the BOUNCE data infrastructure, . Further accessible only through the data are available through the Data Access APIaccess APIs. How the data are going to be used during ▇▇▇▇▇▇’s lifetime Data is used according shared through secured link to partners who are involved in WPs regarded to processing of the data, modelling, model computational implementation and integration and performance evaluation and analysis. The usage of data is described in the data sharing agreements by ICCS, FORTH and SiLoagreements. How the data are going to be used after ▇▇▇▇▇▇’s lifetime The data As will be available to representatives of FORTHagreed Related WPs Data is generated in WP6 and will be used in WP4, ICCS WP5, WP6 and SiLo for one year as WP7. Access rights As described in the data sharing agreements through the BOUNCE data repository available for further exploitation through new models that might be developed by consortium members and according to the exploitation plan developed within the consortium. Related WPs WP 3,4,5 Access rights Data is used according to data sharing agreements by ICCS, FORTH and SiLoagreements. Anonymisation / Pseudonumisation The data is pseudonymized and all the personal identifiers Data are removed. The identifiers are not available for BOUNCE group they are owned by the BREX study group pseudonymised and coded for paper only (not electronically available)before the delivery and the codes will remain in HUS. Collection workflow & methodology Data was will be collected during the BREX trial to CRFs in Filer Maker Pro. BOUNCE prospect pilot 1.11.2017- 1.11.2019 Ethics & GDPR Internal Ethical Committee approval from HUS for was obtained before the usage of data has been received. Since the retrospective nature start of the data no consent was not required. Risk selfcollection Only pseudonymized and coded data without personal IDs is sharable between EU-evaluation according the countries Processes are compliant with GDPR Data sharing agreements has been done. to be approved by HUS lawyer Person in charge ▇▇▇▇▇ ▇▇▇▇▇▇▇▇-▇▇▇▇▇▇▇ Additional Cost No additional cost is foreseen required to access the data or to store them.