D1.5 Report on Audit of Data Management Adherence

Transcription

1 WP1 D1.5 Report on Audit of Data Management Adherence Leading Author(s): René Schippers, Nadia Nardi Status -Version: Version 1.0 Contractual Date: 30 th November 2016 M22 Actual Submission Date: 30 th November 2016 Code: D1.5 Report on Audit of Data Management Adherence.docx 1 30/11/2016

2 Disclaimer This document contains material, which is the copyright of certain PATHway contractors, and may not be reproduced or copied without permission. All PATHway consortium partners have agreed to the full publication of this document. The commercial use of any information contained in this document may require a license from the proprietor of that information. The PATHway Consortium consists of the following members: Participant no. Participant Name Short Name Country 1 Dublin City University DCU Ireland 2 CERTH Information Technologies Institute & Institute of Applied Bioscience CERTH/ITI & CERTH/INAB Greece 3 University of Ulster UU UK 4 Electronic Record Services BV ERS Netherlands 5 Nurogames GMBH NG Germany 6 ENGINEERING-Ingegneria Informatica SPA ENG Italy 7 Katholieke Universiteit Leuven KU Leuven Belgium 8 University of Glasgow UGL UK The information in this document is provided as is and no guarantee or warranty is given that the information is fit for any particular purpose. The user thereof uses the information at its sole risk and liability. 2 30/11/2016

3 Contributors Name René Schippers Nadia Nardi Paolo Zampognaro Roselien Buys Paul de Clercq Company ERS ENG ENG KU Leuven ERS Internal Reviewers Name Company Internal Approval Date Petros Daras CERTH 16 th November 2016 Roselien Buys KU Leuven 23 rd November 2016 Andrew Pomazanskyi, Jens Piesk NG 28 th November 2016 Kieran Moran DCU 30 th November /11/2016

4 Document Revision History Date Issue Author/Editor/Contributor Summary of main changes 10/10/ René Schippers Initial contents 10/10/ Nadia Nardi Initial contents 10/10/ Paolo Zampognaro Initial contents 14/10/ Roselien Buys Contribution from KUL to Dataset Description Template 18/10/ René Schippers Extension of Categories of Data-sets 23/11/ René Schippers Wrap up of text extensions 23/11/ Roselien Buys Edits, text changes and comments 24/11/ Fabio Melillo Updates on source references 24/11/ René Schippers Edits, text changes, updates implemented and text extensions made 27/11/ René Schippers Edits, text changes, updates implemented and text extensions made 29/11/ René Schippers All feedback reviewers addressed 4 30/11/2016

5 Table of Contents Disclaimer... 2 Contributors... 3 Internal Reviewers... 3 Document Revision History... 4 Abbreviations (alphabetically)... 6 Table of Tables... 7 Executive Summary Introduction Inventory of Datasets: Audit Form Detailed data set description definition: Audit Form Auditing process Data set assessment Audit Report on Data Sets Open Access Audit Report on Open Access Corrective Actions Annex A /11/2016

6 Abbreviations (alphabetically) API CR CVD DMP EHR GA Application Programming Interface Cardiac Rehabilitation Cardiovascular Disease Data Management Plan Electronic Health Record Grant Agreement HDMS Health Data Management System ID RCT Identifier Randomized Controlled Trial 6 30/11/2016

7 Table of Tables Table 1: Inventory of Data Sets (Audit Form 1 in Annex A) Table 2: EU Commission Data Management Plan Template Table 3: Extensions to EU Commission Data Management Plan Template Table 4: Form 2 of Data Set PatientPhysicalProgress Table 5: Table 2 of Data Set PatientBehaviouralChangeProgress Table 6: Form 2 of Data Set PatientPhysicalProgramme Table 7: Form 2 of Data Set BehaviouralChangeProgramme Table 8: Form 2 of Data Set patientlifestypeassessment Table 9: Form 2 of Data Set PatientClinicalData Table 10: Form 2 of Data Set PatientPersonalInfo Table 11: Form 2 of Data Set EducationAndTraining Table 12: Form 2 of Data Set UserRequirementsAssessment Table 13: Form 2 of Data Set EvaluationCampaigns Table 14: Form 2 of Data Set ProjectOutputDeliverables Table 15: Form 2 of Data Set ProjectOutputDissemination Table 16: Form 2 of Data Set RandomisedControlledTrialData Table 17: Form 2 of Data Set HealthEconomicsData Table 18: Form 2 of Data Set ProjectOutputScientificPapers Table 19 Guide for the datasets produced in the PATHway project. 7 30/11/2016

8 Executive Summary PATHway will provide individualized rehabilitation programs that use regular, socially inclusive exercise sessions as the basis upon which to provide a personalized comprehensive lifestyle intervention program [exercise/physical activity (PA), smoking, healthy eating, stress, alcohol, and medication adherence] to enable patients to both better understand and deal with their own condition and to lead a healthier lifestyle in general. Using IT-systems, sensors, gaming, and patient interactions with these systems the rehabilitation process is supported. Within Task 1.2 (Data Management) the data management plan (D1.3) comprises two parts: firstly identifying from the start of the project, relevant legal, regulatory and ethical requirements for managing patient and clinical data; and secondly recording the technical and standard requirements for adhering to H2020 goals of open data access where permitted (GA Part A page 10). This document (D1.5) is the self-audit (D1.5) component of Task 1.2; to check the compliance with the Data Management Plan (D1.3) with regards to the identification of legal, regulatory, ethical, security requirements and updates on those requirements, and the definition of the self-audit process. This self-audit is done at a moment during the project in which a first release of the software has been done and the RCT phase still needs to start (Deployment of PATHway in the hospital in M28 May 2017; Deployment of PATHway in the patients homes in M30 July 2017). It is the scope of the self-audit to prescribe corrective actions (if necessary) and outline any changes or updates to the data management plan. It is foremost the scope of this deliverable to execute the self-audit process and document what kind of categories of data are produced during the lifecycle of the project, how the data is used during the project, preserved after project closure and becomes available under EU Open Access policy. 8 30/11/2016

9 The Data Management Plan (D1.3) was updated because text related to the possible deployment of the HDMS inside hospitals was ruled out (due to issues from the hospitals in directly accessing personal records) and a subsequent change in technology of PATHway system component HDMS. The HDMS is used to document all PATHway system usage by patients, supporting the sound working of all individual components which the PATHway system comprises of, using an extensive Application Programming Interface (API) to feed those other components with data stored in the HDMS, and data entry functionality to allow program generation and individualization. This document describes the actual Self-Audit Process outcomes of the Data Management Plan Adherence as part of the PATHway Data Management T1.2. Relevant deliverables for this document are Data Management Plan (D1.3), Human intervention study design and ethical analysis (D5.1), PATHway Unified Data Model and system architecture specification v2 (D4.3) and Use-cases and function requirements definition v2 (D2.5), because those deliverables need to be synchronized with the self-audit (D1.5) outcomes. The before-mentioned deliverables are fully synchronized with D1.5. This deliverable (D1.5) is reviewed or contributed to by all Lead Beneficiaries of all Work Packages of PATHway project. In Chapter 2 the detailed data set categories used in PATHway are identified (Form 1 as mentioned in Annex A). In Chapter 3 the EU commission Data Management Plan Template, as introduced in DMP D1.3, is enriched with some extra attributes (Form 2 as mentioned in Annex A) in order to indicate the position of the datasets within PATHway and describe their envisioned use towards the project objectives. In Chapter 4 the auditing process is described using a data set assessment (Form 2 as mentioned in Annex A) per identified data set (Chapter 3) and conclusions are listed. In Chapter 5 the compliance with EU Open Access policies is assessed using the EU- Commission Open Data Template. 9 30/11/2016

10 In Chapter 6 corrective actions are listed due to the assessments executed in Chapters 4 and 5. The intended audiences of this deliverable are the project partners that are active in: Wp 2 - Requirements, user needs analysis and exercise programme design, and Wp 4 - PATHway platform specification, implementation and validation. Wp 5 Evaluation of PATHway /11/2016

11 1 Introduction For a sound understanding of the self-audit process outcomes, the check on DMP adherence and corrective actions needed or taken, it is important to know that important decisions were taken during the Amsterdam PATHway Technical Meeting on February 16 th and 17 th 2016, after D1.3 (Data Management Plan) was published in May These decisions are presented in the context of statements made (quote s in italic) in the PATHway Grant Agreement related to T1.2 Data Management. Quote 1: The PATHway project has actively considered the importance of data management, particularly with respect to the responsibilities of support for open access to publicly funded research data, while also adhering to legal and ethical guidance for handling personally identifying data and linking to patient records. (GA Part B page 44) The linking to patients records in use of hospitals enrolling patients for the RCT, also based on local deployment inside hospital IT domain, was investigated and considered not feasible. Decision 1: In the PATHway project the PATHway system component containing the data (HDMS) is not linked to EHR and PAS systems used in PATHway trial participating institutions. The PATHway system services are centrally deployed, in conformance with the statement made in the GA Part B page 33. Quote 2: Three general types of data have been identified as part of the project: (i) accessed personal and clinical data, (ii) captured and tracked sensor data (including audio/visual, motion and physiological readings) and user provided responses (e.g., smoking, diet, stress management), and (iii) created data (such as the exercise definitions) as content within PATHway or the secondary output from data analytics performed on the primary sensor data. (GA Part B page 44) 11 30/11/2016

12 Decision 2: (As a consequence of decision 1) the (i) accessed personal and clinical data needed in the HDMS for PATHway solution to work was evaluated, because no longer the HDMS is used to document data for patient enrolment in the Randomized Clinical Trial (RCT) using systems integration with locally deployed Laboratory and Drug/Medication systems. Only the HDMS component (ERS) as part of PATHway system stores data. This centrally stored data is used by the other components of the PATHway system like: - Usage & Reporting Front-End Application (ENG); - PATHway Decision support system for individualised exercise programmes (CERTH-INAB); - Notification Service (DCU) and - Exercising Application (NG). ENG, CERTH-INAB, DCU and NG components do not store data in their components that is already stored in the HDMS except that in the Exercise Application a backup copy of the ExerClass Exercise Description is stored in order to allow the patient to have a Practice Individual Exercise (H_UC23) also in the case connection with the HDMS is down. Other components produce data that is stored centrally: - Devices producing sensor data like ECG data producing Zensor (UU) and heart rate (MS- Band); - Human motion capturing, exercise recognition & evaluation, Human Motion Analysis (CERTH-ITI) and - Ability to detect emotion while exercising using facial recognition (DCU), are used to smarten the PATHway system and make it more interactive and individualised in its use /11/2016

13 The Clinical & Research FE Application of the HDMS, using an extensive set of Application programming Interfaces (API s), allows the components and patient to get the data of the underlying database of the HDMS and also to write\store data in the underlying database of the HDMS. The Pathway self-audit as part of the Data Management Plan (DMP) has as objective to assess whether or not the DMP is adhered to fully, or if corrective actions need to be taken. The above mentioned decision 2 is an example of a corrective action. 2 Inventory of Datasets: Audit Form 1 The current chapter is aiming to provide a detailed description of all the foreseen PATHway datasets. Such data sets have been identified by a deep analysis of results from mainly WP2, WP3, WP5 and WP6. It summarises all actions listed in Annex A starting from number 1.1 to 2.5. In Annex A the process flow chart of the self-audit, as introduced in D1.3, is added for a better understanding of the self-audit process. The following table 1 represents Form 1 in the self-audit flow chart and summarises the PATHway datasets identified. Prefixes are given to the categories, alongside a short description of the nature of the specified datasets. No Naming Prefix Description 01 DS_PatientPhysicalProgress Dataset related to the progress of the patient, from a physical point of view, while advancing during the rehabilitation steps. 02 DS_PatientBehaviouralChangeProgress Dataset related to the progress of the patient, from a behavioural change point of view, while advancing during the rehabilitation steps. 03 DS_PatientPysicalProgramme Dataset related to the prescription of physical programmes prescribed by doctors and eventually updated by the system 13 30/11/2016

14 04 DS_BehaviouralChangeProgramme Dataset related to the behavioural change goals associated to the patient (among those available in the platform). 05 DS_PatientLifestyleAssessment Dataset containing data related to patient answers to lifestyle assessment questionnaires 06 DS_PatientClinicalData Dataset containing data related to patient clinical information 07 DS_PatientPersonalInfo Dataset containing the personal details about patients like for instance: personal info, demographic info, data related to devices\sensors used by the patient during rehab. 08 DS_EducationAndTraining Datasets of Educational and Training Content to support patient in behavioural change effort. 09 DS_UserRequirementsAssessment Datasets containing outcomes and information related to the assessment/feedback on user requirements provided by final users organized in working groups. 10 DS_EvaluationCampaigns Other Datasets collected during the Test Campaigns of the project categorized with regards to the collection site 11 DS_ProjectOutputDeliverables Datasets of deliverables produced by the PATHway project 12 DS_ProjectOutputDissemination Datasets of dissemination material produced by the PATHway project 14 30/11/2016

15 13 DS_RandomisedControlledTrialData Datasets collected during clinical trial execution and related to research questions regarding exercise physiology, behavioural change and cardiovascular health. 14 DS_HealthEconomicsData Datasets collected during clinical trial executing and related to health economics/efficacy study research questions 15 DS_ProjectOutputScientificPapers Datasets of scientific papers produced by the PATHway project Table 1 Inventory of Data Sets (Audit Form 1 in Annex A) 15 30/11/2016

16 3 Detailed data set description definition: Audit Form 2 Such descriptions will be carried out through the use of the template of DMP established by the European Commission for Horizon 2020 already reported in D1.3 (Table 2). Meta-data Description Comment Data reference name Set and Identifier for the data set to be produced Standards metadata and Reference to existing suitable standards of the discipline. If these do not exist, an outline on how and what metadata will be created. Data Sharing Description of how data will be shared, including access procedures, embargo periods (if any), outlines of technical mechanisms for dissemination and necessary software and other tools for enabling re-use, and definition of whether access will be widely open or restricted to specific groups. Identification of the repository where data will be stored, if already existing and identified, indicating in particular the type of repository (institutional, standard repository for the discipline, etc.). In case the dataset cannot be shared, the reasons for this should be mentioned (e.g. ethical, rules of personal data, intellectual property, commercial, privacy-related, security-related) /11/2016

17 Meta-data Description Comment Archiving and preservation (including storage and backup) Description of the procedures that will be put in place for long-term preservation of the data. Indication of how long the data should be preserved, what is its approximated end volume, what the associated costs are and how these are planned to be covered? Table 2 - EU Commission Data Management Plan Template The definition of all the related aspects of dataset categories, reported in the template, indicates the importance of long-term preservation of data and the requirement for the widest possible sharing of the knowledge created by EU projects. In order to indicate the position of the datasets within PATHway and describe their envisioned use towards the project objectives, a number of fields were added to the above template as reported below: Field Relation to the PATHway objectives Related workpackages Ethical issues and requirements Description This aspect is introduced in order to provide a summary on how the specific dataset is going to be used within the project and how it is expected to contribute for the successful delivery of the project objectives. List of all the related tasks and work packages of the project s description of work that are related to the specific type of data Description of any ethical requirements and suggestions for mitigation strategies in the case of identified risks /11/2016

18 Table 3 Extensions to EU Commission Data Management Plan Template 4 Auditing process 4.1 Data set assessment For each dataset reported in chapter 2 in the self-audit Form 1, an evaluation activity has been executed coherently with the self-audit process described in D1.3 using an enriched self-audit Form 2 as described in chapter 3 table 2 and table 3. Dataset Description 01 This dataset is related to the progress of the patient, from a physical point of view, while advancing during the rehabilitation steps. It consists in detail of exercise session information being each session an ExerClass an ExerGame or an ActiveLifestyle. Details about the informational content of such entities are in D4.3 - figure 17 Naming Prefix: Generated/Collected: Origin(s): Nature: DS_PatientPhysicalProgress Generated N/A Database record Scale: Potential use: Scientific publication: The general use is to allow the PATHway solution validation. In particular this dataset will be used to evaluate adherence to PATHway and as such support the interpretation of the outcomes from the PATHway RCT and other study protocols for clinical research in the field of CR. The usage of this dataset underpins the possibility of scientific publications: scientific papers have been and/or will be 18 30/11/2016

19 Position within PATHway project published by leveraging this dataset. Relation to the project objective: Related work packages: PATHway is aiming to develop a novel approach for CR for patients with stable cardiovascular disease. It is therefore considered of fundamental importance to maintain the dataset of patient sessions which will be used also as needed data for trial final evaluation. WP3, WP4, WP5 Data and Metadata Standard Data and metadata representation standards: This data are made available via an export by the PATHway open data access platform (HDMS application) by following the standard CSV and/or Excel and/or XML suitable for import in SAS statistical software package and merged with the data collected during the RCT and managed via OpenClinica. OpenClinica data will be exported to Excel or CSV. Dataset Sharing Access Procedure: Embargo period: The user has to be authorised by the system to have access to the data, thus access rights have been defined and are actually supported by the open data access platform (HDMS application) No specific embargo period for data stored in HDMS: the data have been made 19 30/11/2016

20 available, based on the appropriate access roles, as they were produced through the open data access platform (HDMS application) user interface. The exported data in Excel or CSV will be made available in open access after one year embargo period. Dissemination mechanism: Software and tools for reuse: Access right By use of the HDMS during RCT phase for those (1) granted access rights by the Research Data Manager for RCT execution, by use of the research database, holding anonymized data exported from HDMS, for those (2) granted access rights by the Research Data Manager, e.g. to validate conclusions based on the data collected for publications in scientific papers, via in CSV or Excel format data holding files and (3) general public via scientific publications. No specific type of software required. Required characteristics include reading capabilities of CSV and/or SPSS and/or XML and/or Excel In this stage of the project the data set is available to the Research Data Manager for the evaluation through the open data access platform (HDMS application). The CR Program Supervisors of project partners only have access to data of the patients they treat, as needed for the trial 20 30/11/2016

21 execution. Repository where data will be stored: The dataset will be accommodated at the open data access platform (HDMS application) during RCT phase and as anonymized data at the HDMS Research database. Dataset archive and preservation For how long should the data be preserved? Approximated end volume of data: Indicative associated costs for data archiving and preservation: This dataset will be preserved online for as long as there are regular downloads within the online platform of the PATHway system. After that, when data is exported for (statistical) analysis related to study protocol research questions, it will be made accessible by the Research Data Manager (KUL) on request. Data will be preserved for 10 years to address legal and good medical practice requirements and for possible re-use of data for similar clinical studies. Unknown at this stage. The final volume will depend on several variables (e.g. achieving to recruit the target number of patients, individual exercise prescriptions, average number of sessions executed etc.). There are no extra costs associated with its preservation of the data. Ethical issues and requirements 21 30/11/2016

22 The data collected have been carefully anonymized, when exported out of the HDMS application for statistical analysis of the data, for the preservation of the privacy of the participants. The (re)-use of the data collected is ruled by the Informed Consent Form (Annex B). Table 4 Form 2 of Data Set PatientPhysicalProgress Dataset Description 02 This dataset is related to the progress of the patient, from a behavioural change point of view, while advancing during the rehabilitation steps. Details about the informational content of such entities are in D4.3 - figure 13. Naming Prefix: Generated/Collected: Origin(s): Nature: DS_PatientBehaviouralChangeProgress Generated N/A Database record Scale: Potential use: Scientific publication: The general use is to allow the PATHway solution validation. In particular this dataset will be used to evaluate adherence to PATHway and as such support the interpretation of the outcomes from the PATHway RCT and other study protocols for clinical research in the field of CR. The usage of this dataset underpins the possibility of scientific publications: scientific papers have been and/or will be published by leveraging this dataset. Position within PATHway project 22 30/11/2016

23 Relation to the project objective: Related work packages: PATHway is aiming to develop a novel approach for CR for patients with stable cardiovascular disease. It is therefore considered of fundamental importance to maintain the dataset of patient sessions which will be used also as needed data for trial final evaluation. WP3,WP4,WP5 Data and Metadata Standard Data and metadata representation standards: This data are made available via an export by the PATHway open data access platform (HDMS application) by following the standard CSV and/or Excel and/or XML suitable for import in SAS statistical software package and merged with the data collected during the RCT and managed via OpenClinica. OpenClinica data will be exported to Excel or CSV. Dataset Sharing Access Procedure: Embargo period: The user has to be authorised by the system to have access to the data, thus access rights have been defined and are actually supported by the open data access platform (HDMS application) No specific embargo period for data stored in HDMS: the data have been made available, based on the appropriate access roles, as they were produced through the open data access platform (HDMS 23 30/11/2016

24 application) user interface. The exported data in Excel or CSV will be made available in open access after one year embargo period. Dissemination mechanism: Software and tools for reuse: Access right Repository where data will be stored: By use of the HDMS during RCT phase for those (1) granted access rights by the Research Data Manager for RCT execution, by use of the research database, holding anonymized data exported from HDMS, for those (2) granted access rights by the Research Data Manager, e.g. to validate conclusions based on the data collected for publications in scientific papers, via in CSV or Excel format data holding files and (3) general public via scientific publications. No specific type of software required. Required characteristics include reading capabilities of CSV and/or SPSS and/or XML and/or Excel In this stage of the project the data set is available to the Research Data Manager for the evaluation through the open data access platform (HDMS application). The CR Program Supervisors of project partners only have access to data of the patients they treat, as needed for the trial execution The dataset will be accommodated at the open data access platform (HDMS application) during RCT phase and as 24 30/11/2016

25 Dataset archive and preservation anonymized data at the HDMS Research database. For how long should the data be preserved? Approximated end volume of data: Indicative associated costs for data archiving and preservation: This dataset will be preserved online for as long as there are regular downloads within the online platform of the PATHway system. After that, when data is exported for (statistical) analysis related to study protocol research questions, it will be made accessible by Research Data Manager (KUL) on request. Data will be preserved for 10 years to address legal and good medical practice requirements and for possible re-use of data for similar clinical studies. Unknown at this stage. The final volume will depend on several variables (e.g. achieving to recruit the target number of patients, individual exercise prescriptions, average number of sessions executed etc.). There are no extra costs associated with its preservation of the data. Ethical issues and requirements The data collected have been carefully anonymized, when exported out of the HDMS application for statistical analysis of the data, for the preservation of the privacy of the participants. The (re)-use of the data collected is ruled by the Informed Consent Form. Table 5 Table 2 of Data Set PatientBehaviouralChangeProgress 25 30/11/2016

26 Dataset Description 03 This dataset is related to the prescription of physical programmes prescribed by doctors and eventually updated by the system. Details about the informational content of such entities is in D4.3 - figure 11 Naming Prefix: Generated/Collected: Origin(s): Nature: DS_PatientPhysicalProgramme Collected Generated N/A Database record Scale: Potential use: Scientific publication: The general use is to allow the PATHway solution validation. In particular this dataset will be used to evaluate adherence to PATHway and as such support the interpretation of the outcomes from the PATHway RCT and other study protocols for clinical research in the field of CR. The usage of this dataset underpins the possibility of scientific publications: scientific papers have been and/or will be published by leveraging this dataset. Position within PATHway project Relation to the project objective: PATHway is aiming to develop a novel approach for CR for patients with stable cardiovascular disease. It is therefore considered of fundamental importance to maintain the dataset of patient sessions which will be used also as needed data for 26 30/11/2016

27 trial final evaluation. Related work packages: WP3,WP4,WP5 Data and Metadata Standard Data and metadata representation standards: This data are made available via an export by the PATHway open data access platform (HDMS application) by following the standard CSV and/or Excel and/or XML suitable for import in SAS statistical software package and merged with the data collected during the RCT and managed via OpenClinica. OpenClinica data will be exported to Excel or CSV. Dataset Sharing Access Procedure: Embargo period: The user has to be authorised by the system to have access to the data, thus access rights have been defined and are actually supported by the open data access platform (HDMS application) No specific embargo period for data stored in HDMS: the data have been made available, based on the appropriate access roles, as they were produced through the open data access platform (HDMS application) user interface. The exported data in Excel or CSV will be made available in open access after one year embargo period /11/2016

28 Dissemination mechanism: Software and tools for reuse: Access right Repository where data will be stored: By use of the HDMS during RCT phase for those (1) granted access rights by the Research Data Manager for RCT execution, by use of the research database, holding anonymized data exported from HDMS, for those (2) granted access rights by the Research Data Manager, e.g. to validate conclusions based on the data collected for publications in scientific papers, via in CSV or Excel format data holding files and (3) general public via scientific publications. No specific type of software required. Required characteristics include reading capabilities of CSV and/or SPSS and/or XML and/or Excel In this stage of the project the data set is available to the Research Data Manager for the evaluation through the open data access platform (HDMS application). The CR Program Supervisors of project partners only have access to data of the patients they treat, as needed for the trial execution. The dataset will be accommodated at the open data access platform (HDMS application) during RCT phase and as anonymized data at the HDMS Research database. Dataset archive and preservation 28 30/11/2016

29 For how long should the data be preserved? Approximated end volume of data: Indicative associated costs for data archiving and preservation: This dataset will be preserved online for as long as there are regular downloads within the online platform of the PATHway system. After that, when data is exported for (statistical) analysis related to study protocol research questions, it will be made accessible by Research Data Manager (KUL) on request. Data will be preserved for 10 years to address legal and good medical practice requirements and for possible re-use of data for similar clinical studies. Unknown at this stage. The final volume will depend on several variables (e.g. achieving to recruit the target number of patients, individual exercise prescriptions, average number of sessions executed etc.). There are no extra costs associated with its preservation of the data. Ethical issues and requirements The data collected have been carefully anonymized, when exported out of the HDMS application for statistical analysis of the data, for the preservation of the privacy of the participants. The (re)-use of the data collected is ruled by the Informed Consent Form. Table 6 Form 2 of Data Set PatientPhysicalProgramme Dataset Description 04 This dataset is related to the behavioural change goals associated to the patient (among those available in the platform). Details about the informational content of such entities is 29 30/11/2016

30 in D4.3 - figure 9 Naming Prefix: Generated/Collected: Origin(s): Nature: DS_BehaviouralChangeProgramme Collected N/A Database record Scale: Potential use: Scientific publication: The general use is to allow the PATHway solution validation. In particular this dataset will be used to evaluate adherence to PATHway and as such support the interpretation of the outcomes from the PATHway RCT and other study protocols for clinical research in the field of CR. The usage of this dataset underpins the possibility of scientific publications: scientific papers have been and/or will be published by leveraging this dataset. Position within PATHway project Relation to the project objective: Related work packages: PATHway is aiming to develop a novel approach for CR for patients with stable cardiovascular disease. It is therefore considered of fundamental importance to maintain the dataset of patient sessions which will be used also as needed data for trial final evaluation. WP3, WP4, WP /11/2016

31 Data and Metadata Standard Data and metadata representation standards: This data are made available via an export by the PATHway open data access platform (HDMS application) by following the standard CSV and/or Excel and/or XML suitable for import in SAS statistical software package and merged with the data collected during the RCT and managed via OpenClinica. OpenClinica data will be exported to Excel or CSV. Dataset Sharing Access Procedure: Embargo period: Dissemination mechanism: The user has to be authorised by the system to have access to the data, thus access rights have been defined and are actually supported by the open data access platform (HDMS application) No specific embargo period for data stored in HDMS: the data have been made available, based on the appropriate access roles, as they were produced through the open data access platform (HDMS application) user interface. The exported data in Excel or CSV will be made available in open access after one year embargo period. By use of the HDMS during RCT phase for those (1) granted access rights by the Research Data Manager for RCT execution, by use of the research database, holding 31 30/11/2016

32 anonymized data exported from HDMS, for those (2) granted access rights by the Research Data Manager, e.g. to validate conclusions based on the data collected for publications in scientific papers, via in CSV or Excel format data holding files and (3) general public via scientific publications. Software and tools for reuse: Access right Repository where data will be stored: No specific type of software required. Required characteristics include reading capabilities of CSV and/or SPSS and/or XML and/or Excel In this stage of the project the data set is available to the Research Data Manager for the evaluation through the open data access platform (HDMS application). The CR Program Supervisors of project partners only have access to data of the patients they treat, as needed for the trial execution. The dataset will be accommodated at the open data access platform (HDMS application) during RCT phase and as anonymized data at the HDMS Research database. Dataset archive and preservation For how long should the data be preserved? This dataset will be preserved online for as long as there are regular downloads within the online platform of the PATHway system. After that, when data is exported 32 30/11/2016

33 for (statistical) analysis related to study protocol research questions, it will be made accessible by Research Data Manager (KUL) on request. Data will be preserved for 10 years to address legal and good medical practice requirements and for possible re-use of data for similar clinical studies. Approximated end volume of data: Indicative associated costs for data archiving and preservation: Unknown at this stage. The final volume will depend on several variables (e.g. achieving to recruit the target number of patients, individual exercise prescriptions, average number of sessions executed etc..). There are no extra costs associated with its preservation of the data. Ethical issues and requirements The data collected have been carefully anonymized, when exported out of the HDMS application for statistical analysis of the data, for the preservation of the privacy of the participants. The (re)-use of the data collected is ruled by the Informed Consent Form. Table 7 Form 2 of Data Set BehaviouralChangeProgramme Dataset Description 05 This dataset is related to the patient answers to lifestyle assessment questionnaires. Details about the informational content of such entities is in D4.3 - figure 13 Naming Prefix: Generated/Collected: DS_PatientLifestypeAssessment Collected 33 30/11/2016

34 Origin(s): Nature: N/A Database record Scale: Potential use: Scientific publication: The general use is to allow the PATHway solution validation. In particular this dataset will be used to evaluate adherence to PATHway and as such support the interpretation of the outcomes from the PATHway RCT and other study protocols for clinical research in the field of CR. The usage of this dataset underpins the possibility of scientific publications: scientific papers have been and/or will be published by leveraging this dataset. Position within PATHway project Relation to the project objective: Related work packages: PATHway is aiming to develop a novel approach for CR for patients with stable cardiovascular disease. It is therefore considered of fundamental importance to maintain the dataset of patient sessions which will be used also as needed data for trial final evaluation. WP3, WP4, WP5 Data and Metadata Standard Data and metadata representation standards: This data are made available via an export by the PATHway open data access platform (HDMS application) by following the standard CSV and/or Excel and/or XML 34 30/11/2016

35 suitable for import in SAS statistical software package and merged with the data collected during the RCT and managed via OpenClinica. OpenClinica data will be exported to Excel or CSV. Dataset Sharing Access Procedure: Embargo period: Dissemination mechanism: The user has to be authorised by the system to have access to the data, thus access rights have been defined and are actually supported by the open data access platform (HDMS application) No specific embargo period for data stored in HDMS: the data have been made available, based on the appropriate access roles, as they were produced through the open data access platform (HDMS application) user interface. The exported data in Excel or CSV will be made available in open access after one year embargo period. By use of the HDMS during RCT phase for those (1) granted access rights by the Research Data Manager for RCT execution, by use of the research database, holding anonymized data exported from HDMS, for those (2) granted access rights by the Research Data Manager, e.g. to validate conclusions based on the data collected for publications in scientific papers, via in CSV 35 30/11/2016

36 or Excel format data holding files and (3) general public via scientific publications. Software and tools for reuse: Access right Repository where data will be stored: No specific type of software required. Required characteristics include reading capabilities of CSV and/or SPSS and/or XML and/or Excel In this stage of the project the data set is available to the Research Data Manager for the evaluation through the open data access platform (HDMS application). The CR Program Supervisors of project partners only have access to data of the patients they treat, as needed for the trial execution. The dataset will be accommodated at the open data access platform (HDMS application) during RCT phase and as anonymized data at the HDMS Research database. Dataset archive and preservation For how long should the data be preserved? This dataset will be preserved online for as long as there are regular downloads within the online platform of the PATHway system. After that, when data is exported for (statistical) analysis related to study protocol research questions, it will be made accessible by Research Data Manager (KUL) on request. Data will be preserved for 10 years to address legal and good 36 30/11/2016

37 medical practice requirements and for possible re-use of data for similar clinical studies. Approximated end volume of data: Indicative associated costs for data archiving and preservation: Unknown at this stage. The final volume will depend on several variables (e.g. achieving to recruit the target number of patients, individual exercise prescriptions, average number of sessions executed etc..). There are no extra costs associated with its preservation of the data. Ethical issues and requirements The data collected have been carefully anonymized, when exported out of the HDMS application for statistical analysis of the data, for the preservation of the privacy of the participants. The (re)-use of the data collected is ruled by the Informed Consent Form. Table 8 Form 2 of Data Set patientlifestypeassessment Dataset Description 06 This dataset contains data related to the patient clinical information and measurements collected by devices. Details about the informational content of such entities is in D4.3 - figure 8 Naming Prefix: Generated/Collected: Origin(s): Nature: DS_PatientClinicalData Generated N/A Database record Scale: 37 30/11/2016

38 Potential use: Scientific publication: The general use is to allow the PATHway solution validation. In particular this dataset will be used to evaluate adherence to PATHway and as such support the interpretation of the outcomes from the PATHway RCT and other study protocols for clinical research in the field of CR. The usage of this dataset underpins the possibility of scientific publications: scientific papers have been and/or will be published by leveraging this dataset. Position within PATHway project Relation to the project objective: Related work packages: PATHway is aiming to develop a novel approach for CR for patients with stable cardiovascular disease. It is therefore considered of fundamental importance to maintain the dataset of patient sessions which will be used also as needed data for trial final evaluation. WP3, WP4, WP5 Data and Metadata Standard Data and metadata representation standards: This data are made available via an export by the PATHway open data access platform (HDMS application) by following the standard CSV and/or Excel and/or XML suitable for import in SAS statistical software package and merged with the data collected during the RCT and managed via OpenClinica. OpenClinica data will be 38 30/11/2016

39 Dataset Sharing exported to Excel or CSV. Access Procedure: Embargo period: Dissemination mechanism: Software and tools for reuse: The user has to be authorised by the system to have access to the data, thus access rights have been defined and are actually supported by the open data access platform (HDMS application) No specific embargo period for data stored in HDMS: the data have been made available, based on the appropriate access roles, as they were produced through the open data access platform (HDMS application) user interface. The exported data in Excel or CSV will be made available in open access after one year embargo period. By use of the HDMS during RCT phase for those (1) granted access rights by the Research Data Manager for RCT execution, by use of the research database, holding anonymized data exported from HDMS, for those (2) granted access rights by the Research Data Manager, e.g. to validate conclusions based on the data collected for publications in scientific papers, via in CSV or Excel format data holding files and (3) general public via scientific publications. No specific type of software required. Required characteristics include reading 39 30/11/2016

40 capabilities of CSV and/or SPSS and/or XML and/or Excel Access right Repository where data will be stored: In this stage of the project the data set is available to the Research Data Manager for the evaluation through the open data access platform (HDMS application). The CR Program Supervisors of project partners only have access to data of the patients they treat, as needed for the trial execution. The dataset will be accommodated at the open data access platform (HDMS application) during RCT phase and as anonymized data at the HDMS Research database. Dataset archive and preservation For how long should the data be preserved? This dataset will be preserved online for as long as there are regular downloads within the online platform of the PATHway system. After that, when data is exported for (statistical) analysis related to study protocol research questions, it will be made accessible by Research Data Manager (KUL) on request. Data will be preserved for 10 years to address legal and good medical practice requirements and for possible re-use of data for similar clinical studies /11/2016

41 Approximated end volume of data: Indicative associated costs for data archiving and preservation: Unknown at this stage. The final volume will depend on several variables (e.g. achieving to recruit the target number of patients, individual exercise prescriptions, average number of sessions executed etc..). There are no extra costs associated with its preservation of the data. Ethical issues and requirements The data collected have been carefully anonymized, when exported out of the HDMS application for statistical analysis of the data, for the preservation of the privacy of the participants. The (re)-use of the data collected is ruled by the Informed Consent Form. Table 9 Form 2 of Data Set PatientClinicalData Dataset Description 07 This dataset contains the personal details about patients like for instance: personal info, demographic info, data related to devices/sensors used by the patient during rehabilitation. Details about the informational content of such entities is in D4.3 - figure 8 Naming Prefix: Generated/Collected: Origin(s): Nature: DS_PatientPersonalInfo Generated N/A Database record Scale: Potential use: The general use is to allow the PATHway solution validation. In particular this dataset will be used to link data produced using the PATHway solution to the correct 41 30/11/2016

42 patient record and Patient Identification Code (PIC) as used in RCT Scientific publication: N/A Position within PATHway project Relation to the project objective: Related work packages: PATHway is aiming to develop a novel approach for CR for patients with stable cardiovascular disease. It is therefore considered of fundamental importance to maintain the dataset of patient sessions which will be used also as needed data for trial final evaluation. WP3, WP4, WP5 Data and Metadata Standard Data and metadata representation standards: This data are made available via an export by the PATHway open data access platform (HDMS application) by following the standard CSV and/or Excel and/or XML suitable for import in SAS statistical software package preserving PIC, Age and Gender data and merged with the data collected during the RCT and managed via OpenClinica. OpenClinica data will be exported to Excel or CSV. Dataset Sharing Access Procedure: The user has to be authorised by the system to have access to the data, thus access rights have been defined and are actually supported by the open data access 42 30/11/2016

43 platform (HDMS application) Embargo period: No specific embargo period: the data have been made available, based on the appropriate access roles, as they were produced through the open data access platform (HDMS application) user interface Dissemination mechanism: No specific dissemination mechanism adopted for this data set: this data set is made available through the open data access platform (HDMS application) user interface and will be used in RCT anonymized Software and tools for reuse: Access right Repository where data will be stored: No specific type of software required. Required characteristics include reading capabilities of CSV and/or SPSS and/or XML and/or Excel In this stage of the project the data set is available to CR Program Supervisors of project partners, Administrator and Research Data Manager only for the trial execution and evaluation through the open data access platform (HDMS application) The dataset will be accommodated at the open data access platform (HDMS application). Dataset archive and preservation For how long should the data be preserved? This dataset will be preserved online for as long as there are regular downloads within 43 30/11/2016

44 the online platform of the PATHway system. After that, when data is exported for (statistical) analysis related to study protocol research questions, it will be made accessible by Research Data Manager (KUL) on request. Data will be preserved for 10 years to address legal and good medical practice requirements and for possible re-use of data for similar clinical studies. Approximated end volume of data: Indicative associated costs for data archiving and preservation: Unknown at this stage, but very limited in volume. There are no extra costs associated with its preservation of the data. Ethical issues and requirements The data collected have been carefully anonymized, when exported out of the HDMS application for statistical analysis of the data, for the preservation of the privacy of the participants. The (re)-use of the data collected is ruled by the Informed Consent Form. Table 10 Form 2 of Data Set PatientPersonalInfo Dataset Description 08 These datasets contain educational and training content to support the patient in behavioural change effort. Details about user requirements are is in D2.5. Naming Prefix: Generated/Collected: Origin(s): Nature: DS_EducationAndTraining Generated N/A File 44 30/11/2016

45 Scale: Potential use: Scientific publication: The general use is to allow the PATHway solution to be used effectively by patients. N/A Position within PATHway project Relation to the project objective: Related work packages: PATHway is aiming to develop a novel approach for CR for patients with stable cardiovascular disease. It is therefore essential that patients use the PATHway solution in a comparative way WP3, WP4, WP5, WP6 Data and Metadata Standard Data and metadata representation standards: N/A Dataset Sharing Access Procedure: Embargo period: Dissemination mechanism: Software and tools for reuse: Access right The user has to be authorised by the system to have access to the data, thus access rights have been defined and are actually supported by the open data access platform (HDMS application) No specific embargo period User experience in Home environment N/A In this stage of the project the data set is available to CR Program Supervisors, Research Data Manager, Administrator and 45 30/11/2016

46 patients Repository where data will be stored: The dataset will be accommodated at the open data access platform (HDMS application). Dataset archive and preservation For how long should the data be preserved? Approximated end volume of data: Indicative associated costs for data archiving and preservation: This dataset will be preserved online for as long as there are regular downloads within the online platform of the PATHway system. After that the dataset stay s part of full PATHway solution description as filed Unknown at this stage. There are no extra costs associated with its preservation of the data. Ethical issues and requirements The data collected have been carefully anonymized, when exported out of the HDMS application for statistical analysis of the data, for the preservation of the privacy of the participants. The (re)-use of the data collected is ruled by the Informed Consent Form. Table 11 Form 2 of Data Set EducationAndTraining Dataset Description 09 These datasets contain outcomes and information related to the assessment/feedback on user requirements provided by final users organized in working groups. Details about user requirements are is in D2.5. Naming Prefix: Generated/Collected: DS_UserRequirementsAssessment Collected 46 30/11/2016

47 Origin(s): Nature: N/A Database record Scale: Potential use: Scientific publication: The general use is to allow the PATHway solution validation. In particular this dataset will be used to evaluate adherence to PATHway and as such support the interpretation of the outcomes from the PATHway RCT and other study protocols for clinical research in the field of CR. The usage of this dataset underpins the possibility of scientific publications: scientific papers have been and/or will be published by leveraging this dataset. Position within PATHway project Relation to the project objective: Related work packages: PATHway is aiming to develop a novel approach for CR for patients with stable cardiovascular disease. It is therefore considered of fundamental importance to maintain the dataset of patient sessions which will be used also as needed data for trial final evaluation. WP3, WP4, WP5 Data and Metadata Standard Data and metadata representation standards: This data are made available via an export by the PATHway open data access platform (HDMS application) by following the standard CSV and/or Excel and/or XML 47 30/11/2016

48 suitable for import in SAS statistical software package and merged with the data collected during the RCT and managed via OpenClinica. OpenClinica data will be exported to Excel or CSV. Dataset Sharing Access Procedure: Embargo period: Dissemination mechanism: The user has to be authorised by the system to have access to the data, thus access rights have been defined and are actually supported by the open data access platform (HDMS application) No specific embargo period for data stored in HDMS: the data have been made available, based on the appropriate access roles, as they were produced through the open data access platform (HDMS application) user interface. The exported data in Excel or CSV will be made available in open access after one year embargo period. By use of the HDMS during RCT phase for those (1) granted access rights by the Research Data Manager for RCT execution, by use of the research database, holding anonymized data exported from HDMS, for those (2) granted access rights by the Research Data Manager, e.g. to validate conclusions based on the data collected for publications in scientific papers, via in CSV 48 30/11/2016

49 or Excel format data holding files and (3) general public via scientific publications. Software and tools for reuse: Access right Repository where data will be stored: No specific type of software required. Required characteristics include reading capabilities of CSV and/or SPSS and/or XML and/or Excel In this stage of the project the data set is available to the Research Data Manager for the evaluation through the open data access platform (HDMS application). The CR Program Supervisors of project partners only have access to data of the patients they treat, as needed for the trial execution. The dataset will be accommodated at the open data access platform (HDMS application) during RCT phase and as anonymized data at the HDMS Research database. Dataset archive and preservation For how long should the data be preserved? This dataset will be preserved online for as long as there are regular downloads within the online platform of the PATHway system. After that, when data is exported for (statistical) analysis related to study protocol research questions, it will be made accessible by Research Data Manager (KUL) on request. Data will be preserved for 10 years to address legal and good 49 30/11/2016

50 medical practice requirements and for possible re-use of data for similar clinical studies. Approximated end volume of data: Indicative associated costs for data archiving and preservation: Unknown at this stage. The final volume will depend on several variables (e.g. achieving to recruit the target number of patients, individual exercise prescriptions, average number of sessions executed etc..). There are no extra costs associated with its preservation of the data. Ethical issues and requirements The data collected have been carefully anonymized, when exported out of the HDMS application for statistical analysis of the data, for the preservation of the privacy of the participants. The (re)-use of the data collected is ruled by the Informed Consent Form. Table 12 Form 2 of Data Set UserRequirementsAssessment Dataset Description 10 These datasets are collected during the test campaigns of the project categorized with regards to the collection site. Details about these datasets are in D4.2 and D4.8. Naming Prefix: Generated/Collected: Origin(s): Nature: DS_EvaluationCampaigns Generated N/A Database record Scale: Potential use: The general use is to allow the PATHway 50 30/11/2016

51 solution validation. In particular this dataset will be used to evaluate adherence to PATHway and as such support the interpretation of the outcomes from the PATHway RCT and other study protocols for clinical research in the field of CR. Scientific publication: The usage of this dataset underpins the possibility of scientific publications: scientific papers have been and/or will be published by leveraging this dataset. Position within PATHway project Relation to the project objective: Related work packages: PATHway is aiming to develop a novel approach for CR for patients with stable cardiovascular disease. It is therefore considered of fundamental importance to maintain the dataset of patient sessions which will be used also as needed data for trial final evaluation. WP3, WP4, WP5 Data and Metadata Standard Data and metadata representation standards: This data are made available via an export by the PATHway open data access platform (HDMS application) by following the standard CSV and/or Excel and/or XML suitable for import in SAS statistical software package and merged with the data collected during the RCT and managed via OpenClinica. OpenClinica data will be 51 30/11/2016

52 Dataset Sharing exported to Excel or CSV. Access Procedure: Embargo period: Dissemination mechanism: Software and tools for reuse: The user has to be authorised by the system to have access to the data, thus access rights have been defined and are actually supported by the open data access platform (HDMS application) No specific embargo period for data stored in HDMS: the data have been made available, based on the appropriate access roles, as they were produced through the open data access platform (HDMS application) user interface. The exported data in Excel or CSV will be made available in open access after one year embargo period. By use of the HDMS during RCT phase for those (1) granted access rights by the Research Data Manager for RCT execution, by use of the research database, holding anonymized data exported from HDMS, for those (2) granted access rights by the Research Data Manager, e.g. to validate conclusions based on the data collected for publications in scientific papers, via in CSV or Excel format data holding files and (3) general public via scientific publications. No specific type of software required. Required characteristics include reading 52 30/11/2016

53 capabilities of CSV and/or SPSS and/or XML and/or Excel Access right Repository where data will be stored: In this stage of the project the data set is available to the Research Data Manager for the evaluation through the open data access platform (HDMS application). The CR Program Supervisors of project partners only have access to data of the patients they treat, as needed for the trial execution. The dataset will be accommodated at the open data access platform (HDMS application). Dataset archive and preservation For how long should the data be preserved? Approximated end volume of data: This dataset will be preserved online for as long as there are regular downloads within the online platform of the PATHway system. After that, when data is exported for (statistical) analysis related to study protocol research questions, it will be made accessible by Research Data Manager (KUL) on request. Data will be preserved for 10 years to address legal and good medical practice requirements and for possible re-use of data for similar clinical studies. Unknown at this stage. The final volume will depend on several variables (e.g. achieving to recruit the target number of 53 30/11/2016

54 patients, individual exercise prescriptions, average number of sessions executed etc..). Indicative associated costs for data archiving and preservation: There are no extra costs associated with its preservation of the data. Ethical issues and requirements The data collected have been carefully anonymized, when exported out of the HDMS application for statistical analysis of the data, for the preservation of the privacy of the participants. The (re)-use of the data collected is ruled by the Informed Consent Form. Table 13 Form 2 of Data Set EvaluationCampaigns Dataset Description 11 These datasets consist of deliverables produced by the PATHway project. Details about the deliverables are in the Grant Agreement. Naming Prefix: Generated/Collected: Origin(s): Nature: DS_ProjectOutputDeliverables Generated N/A File Scale: Potential use: Scientific publication: The general use is to allow the PATHway solution implementation, validation, promotion and (eventually) commercialisation. N/A Position within PATHway project 54 30/11/2016

55 Relation to the project objective: Related work packages: PATHway is aiming to develop a novel approach for CR for patients with stable cardiovascular disease. WP1, WP2, WP3, WP4, WP5, WP6 Data and Metadata Standard Data and metadata representation standards: N/A Dataset Sharing Access Procedure: Embargo period: Dissemination mechanism: Software and tools for reuse: Access right Repository where data will be stored: According to Grant Agreement According to Grant Agreement According to Grant Agreement MS Office tools, PDF Reader N/A for public deliverables Project website Dataset archive and preservation For how long should the data be preserved? Approximated end volume of data: Indicative associated costs for data archiving and preservation: Till project closure as a minimum Unknown at this stage. There are no extra costs associated with its preservation of the data. Ethical issues and requirements N/A Table 14 Form 2 of Data Set ProjectOutputDeliverables 55 30/11/2016

56 Dataset Description 12 These datasets consist of dissemination material produced by the PATHway project. Details about dissemination are in D6.4, D6.1, D6.2 and D6.8, on and progress reports. Naming Prefix: Generated/Collected: Origin(s): Nature: DS_ProjectOutputDissemination Generated N/A File Scale: Potential use: Scientific publication: Dissemination of outcomes Part of dissemination of outcomes Position within PATHway project Relation to the project objective: Related work packages: PATHway is aiming to develop a novel approach for CR for patients with stable cardiovascular disease. WP6 Data and Metadata Standard Data and metadata representation standards: N/A Dataset Sharing Access Procedure: Embargo period: Dissemination mechanism: N/A No specific embargo period Project website, scientific journals, paper 56 30/11/2016

57 based and electronic media Software and tools for reuse: Access right N/A N/A Repository where data will be stored: Website repository Dataset archive and preservation For how long should the data be preserved? Approximated end volume of data: Indicative associated costs for data archiving and preservation: This dataset will be preserved online on project website for project duration and depending of the dissemination mechanism as long as scientific journals and electronic media keep materials online. Unknown at this stage. There are no extra costs associated with its preservation of the data. Ethical issues and requirements N/A Table 15 Form 2 of Data Set ProjectOutputDissemination Dataset Description 13 These datasets consist of existing validated questionnaires related to behavioural change research questions used by the PATHway project. Details about the behavioural change research questions are in D5.1 and D5.2 and scientific publications Naming Prefix: Generated/Collected: Origin(s): DS_RandomisedControlledTrialData Generated N/A 57 30/11/2016

58 Nature: Database record Scale: Potential use: Scientific publication: The general use is to allow the PATHway solution validation. In particular this dataset will be used to evaluate adherence to PATHway and as such support the interpretation of the outcomes from the PATHway RCT and other study protocols for clinical research in the field of CR. The usage of this dataset underpins the possibility of scientific publications: scientific papers have been and/or will be published by leveraging this dataset. Position within PATHway project Relation to the project objective: Related work packages: PATHway is aiming to develop a novel approach for CR for patients with stable cardiovascular disease. It is therefore considered of fundamental importance to maintain the dataset of patient sessions which will be used also as needed data for trial final evaluation. WP3, WP4, WP5 Data and Metadata Standard Data and metadata representation standards: This data are made available via an export by the PATHway open data access platform (HDMS application) by following the standard CSV and/or Excel and/or XML suitable for import in SAS statistical 58 30/11/2016

59 software package and merged with the data collected during the RCT and managed via OpenClinica. OpenClinica data will be exported to Excel or CSV. Dataset Sharing Access Procedure: Embargo period: Dissemination mechanism: The user has to be authorised by the system to have access to the data, thus access rights have been defined and are actually supported by the open data access platform (HDMS application) No specific embargo period for data stored in HDMS: the data have been made available, based on the appropriate access roles, as they were produced through the open data access platform (HDMS application) user interface. The exported data in Excel or CSV will be made available in open access after one year embargo period. By use of the HDMS during RCT phase for those (1) granted access rights by the Research Data Manager for RCT execution, by use of the research database, holding anonymized data exported from HDMS, for those (2) granted access rights by the Research Data Manager, e.g. to validate conclusions based on the data collected for publications in scientific papers, via in CSV or Excel format data holding files and (3) 59 30/11/2016

60 general public via scientific publications. Software and tools for reuse: Access right Repository where data will be stored: No specific type of software required. Required characteristics include reading capabilities of CSV and/or SPSS and/or XML and/or Excel In this stage of the project the data set is available to the Research Data Manager for the evaluation through the open data access platform (HDMS application). The CR Program Supervisors of project partners only have access to data of the patients they treat, as needed for the trial execution. The dataset will be accommodated at the OpenClinica platform (KUL). Dataset archive and preservation For how long should the data be preserved? This dataset will be preserved online for as long as there are regular downloads within the online platform of the PATHway system. After that, when data is exported for (statistical) analysis related to study protocol research questions, it will be made accessible by Research Data Manager (KUL) on request. Data will be preserved for 10 years to address legal and good medical practice requirements and for possible re-use of data for similar clinical studies /11/2016

61 Approximated end volume of data: Unknown at this stage. The final volume will depend on several variables (e.g. achieving to recruit the target number of patients, individual exercise prescriptions, average number of sessions executed etc..). Ethical issues and requirements The data collected have been carefully anonymized, when exported out of the HDMS application for statistical analysis of the data, for the preservation of the privacy of the participants. The (re)-use of the data collected is ruled by the Informed Consent Form. Table 16 Form 2 of Data Set RandomisedControlledTrialData Dataset Description 14 These dataset consist of a validated questionnaire related to health economics research questions used by the PATHway project. Details about the health economics research questions are in D5.3 and scientific publications Naming Prefix: Generated/Collected: Origin(s): Nature: DS_HealthEconomicsData Generated N/A Database record Scale: Potential use: The general use is to allow the PATHway solution validation. In particular this dataset will be used to evaluate adherence to PATHway and as such support the interpretation of the outcomes from the 61 30/11/2016

62 PATHway RCT and other study protocols for clinical research in the field of CR. Scientific publication: The usage of this dataset underpins the possibility of scientific publications: scientific papers have been and/or will be published by leveraging this dataset. Position within PATHway project Relation to the project objective: Related work packages: PATHway is aiming to develop a novel approach for CR for patients with stable cardiovascular disease. It is therefore considered of fundamental importance to maintain the dataset of patient sessions that will be used also as needed data for trial final evaluation. WP3, WP4, WP5 Data and Metadata Standard Data and metadata representation standards: This data are made available via an export by the PATHway open data access platform (HDMS application) by following the standard CSV and/or Excel and/or XML suitable for import in SAS statistical software package and merged with the data collected during the RCT and managed via OpenClinica. OpenClinica data will be exported to Excel or CSV. Dataset Sharing Access Procedure: The user has to be authorised by the system to have access to the data, thus 62 30/11/2016

63 access rights have been defined and are actually supported by the open data access platform (HDMS application) Embargo period: Dissemination mechanism: Software and tools for reuse: Access right No specific embargo period for data stored in HDMS: the data have been made available, based on the appropriate access roles, as they were produced through the open data access platform (HDMS application) user interface. The exported data in Excel or CSV will be made available in open access after one-year embargo period. By use of the HDMS during RCT phase for those (1) granted access rights by the Research Data Manager for RCT execution, by use of the research database, holding anonymized data exported from HDMS, for those (2) granted access rights by the Research Data Manager, e.g. to validate conclusions based on the data collected for publications in scientific papers, via in CSV or Excel format data holding files and (3) general public via scientific publications. No specific type of software required. Required characteristics include reading capabilities of CSV and/or SPSS and/or XML and/or Excel In this stage of the project the data set is available to the Research Data Manager for 63 30/11/2016

64 the evaluation through the open data access platform (HDMS application). The CR Program Supervisors of project partners only have access to data of the patients they treat, as needed for the trial execution. Repository where data will be stored: The dataset will be accommodated at the OpenClinica platform (KUL). Dataset archive and preservation For how long should the data be preserved? Approximated end volume of data: This dataset will be preserved online for as long as there are regular downloads within the online platform of the PATHway system. After that, when data is exported for (statistical) analysis related to study protocol research questions, it will be made accessible by Research Data Manager (KUL) on request. Data will be preserved for 10 years to address legal and good medical practice requirements and for possible re-use of data for similar clinical studies. Unknown at this stage. The final volume will depend on several variables (e.g. achieving to recruit the target number of patients, individual exercise prescriptions, average number of sessions executed etc.). Ethical issues and requirements The data collected have been carefully anonymized, when exported out of the HDMS application for statistical analysis of the data, for the preservation of the privacy of the 64 30/11/2016

65 participants. The (re)-use of the data collected is ruled by the Informed Consent Form. Table 17 Form 2 of Data Set HealthEconomicsData Dataset Description 15 These datasets consist of scientific papers produces by the PATHway project. A detailed overview can be found on Naming Prefix: Generated/Collected: Origin(s): Nature: DS_ProjectOutputScientificPapers Generated N/A File Scale: Potential use: Scientific publication: Dissemination of outcomes 5 to 7 publications are expected about PATHway study design and RCT outcomes in the field of CR, Health Economics related to the efficacy of the PATHway CR approach and Technical Innovations deployed in PATHway solution. Position within PATHway project Relation to the project objective: Related work packages: PATHway is aiming to develop a novel approach for CR for patients with stable cardiovascular disease. WP3, WP4, WP5 and WP6 Data and Metadata Standard Data and metadata representation N/A 65 30/11/2016

66 standards: Dataset Sharing Access Procedure: According to EU-Open Access policy Embargo period: No specific embargo period for the scientific publications. Supportive data in Excel or CSV generated by RCT and Health Economics studies will be made available anonymized in open access after one year embargo period. Dissemination mechanism: Software and tools for reuse: Access right Scientific journals, congresses, website, etc. N/A N/A Repository where data will be stored: The decision on which data sharing services such as OpenData (opendata.europa.eu/en/data/) or EUDAT ( for open access will be used by PATHway still has to be taken Dataset archive and preservation For how long should the data be preserved? Approximated end volume of data: Indicative associated costs for data archiving and preservation: N/A Unknown at this stage, but will be limited in volume N/A Ethical issues and requirements 66 30/11/2016

67 The data collected have been carefully anonymized, when exported out of the HDMS application for statistical analysis of the data, for the preservation of the privacy of the participants. The (re)-use of the data collected is ruled by the Informed Consent Form. Table 18 Form 2 of Data Set ProjectOutputScientificPapers 67 30/11/2016

68 4.2 Audit Report on Data Sets No compliance issues have been identified at this moment, because corrective actions, due to a more concise use of the HDMS, already are being executed. The corrective actions identified are listed in Chapter 7. There is an ongoing need to monitor the compliance to the DMP until the end of the project as Task 1.3 is itself ongoing until the end of the project. Besides this formal reason the present state of affairs is that the PATHway solution (Release 1) is still being tested and will have a new release (R2) and not all (security) requirements identified in D2.5 and D4.3 are yet in place. Phrased differently: There are to do s to execute /11/2016

69 5 Open Access With respect to Open data and research, additional items need to be specified. This can be applied to any project that produces, collects or processes research data, and is included here as reference for elaborating DMPs in Horizon 2020 projects. This guide is structured as a series of questions that should be ideally clarified for all datasets produced in the project. Scientific research data should be easily: discoverable, accessible, assessable, usable, and interoperable. The EU-Commission Open Data Template is used as already being referenced in DMP D1.3. Aspect Question Comment Discoverable DMP question: are the data and associated software produced and/or used in the project discoverable (and readily located), identifiable by means of a standard identification mechanism (e.g. Digital Object Identifier)? Not at present. Only after scientific publications, all are complying with Open Access policy, in which the data and software produced will be referred to. During and after the RCT execution the data is governed according the Informed Consent Form and therefore not discoverable in the HDMS and OpenClinica solutions, used to generate and collect the research data, by others persons than the CR Program Supervisors and Research Data Manager. Accessible DMP question: are the data and associated software produced and/or used in the project accessible and in Commercial exploitation of the PATHway solution, using both the software produced 69 30/11/2016

70 Aspect Question Comment what modalities, scope, licenses (e.g. licensing framework for research and education, embargo periods, commercial exploitation, etc.)? and the software used holding background ip of PATHway partners, is strived for. This makes the software produced accessible. The PATHway solution comprises of seven distinct components, delivered by seven consortium partners, for which a licensing and support framework needs to be developed. Assessable and intelligible DMP question: are the data and associated software produced and/or used in the project assessable for and intelligible to third parties in contexts such as scientific scrutiny and peer review (e.g. are the minimal datasets handled together with scientific papers for the purpose of peer review, are data is provided in a way that judgments can be made about their reliability and the competence of those who created them)? Yes. Data in the datasets categories and 13 and 14 will be assessable for 10 years after project closure in CSV or Excel format suitable for import into SAS and/or SPSS statistical analysis software. Usable beyond the original DMP question: are the data and associated software produced and/or used in the project useable by third The possibility to publish anonymized data, after an embargo period, for (third) 70 30/11/2016

71 Aspect Question Comment purpose for which it was collected parties even long time after the collection of the data (e.g. is the data safely stored in certified repositories for long term preservation and curation; is it stored together with the minimum software, metadata and documentation to make it useful; is the data useful for the wider public needs and usable for the likely purposes of non-specialists)? party use is available. It is not expected that the data will be of interest to non-specialists. The software produced only will work appropriately in the context of a fully operational PATHway solution with most of all of the seven comprising components integrated. Interoperabl e to specific quality standards DMP question: are the data and associated software produced and/or used in the project useable by third parties even long time after the collection of the data (e.g. is the data safely stored in certified repositories for long term preservation and curation; is it stored together with the minimum software, metadata and documentation to make it useful; is the data useful for the wider public needs and usable for the likely purposes of non-specialists)? The data formats used make it possible to import the data into SAS and/or SPSS statistical analysis software. Technology used for ERS HDMS and Research database is a such that both can be generated on request after project closure for as long the present release of the software is supported. To this end the HDMS configuration as used in RCT phase will be preserved. Table 19: Guide for the datasets produced in the PATHway project /11/2016

72 5.1 Audit Report on Open Access The overall conclusion is that the EU-Open Access policy is adhered to the maximum level possible due to legislation on good medical practice as executed in PATHway RCT Informed Consent Form. However there is still one pending decision to be taken. The decision on which data sharing services such as OpenData (opendata.europa.eu/en/data/) or EUDAT ( for open access will be used by PATHway still has to be taken. This decision needs to be taken before second review period is concluded (Month 30) /11/2016

73 6 Corrective Actions A decision on the deployment and subsequent technology of PATHway system component HDMS emerged after publication of Data Management Plan (D1.3) at the end of May The possibility to deploy the HDMS locally at hospital sites inside their IT domain was explored and turned out not to be feasible. Therefor it was decided to deploy the HDMS as a central service, using the internet. As a consequence of this the Electronic Health Record (EHR) and Patent Administration System (PAS) features were removed, because no longer the HDMS is used to document data for patient enrolment in the Randomized Clinical Trial (RCT) and systems integration with locally deployed Laboratory and Drug/Medication systems. Instead the HDMS is used solely to document all PATHway system usage by patients, supporting the sound working of all individual components which the PATHway system comprises of, using an extensive Application Programming Interface (API) to feed those other components with data stored in the HDMS, and data entry functionality to allow program generation and individualization. RCT data and Health Economics/Efficacy Study data is locally managed, out of PATHway system, by KUL using OpenClinica and SAS as software solutions. Corrective actions due to data set assessment: Minimise the data items to be collected under the clinical and personal (demographic) section of the HDMS to the bare minimum needed for the PATHway system to work; Encrypted storing of demographics data in HDMS and Update Data Management Plan (D1.3) accordingly. Corrective action due to open access assessment: Decide (before M30) which data sharing services such as OpenData (opendata.europa.eu/en/data/) or EUDAT ( for open access will be used by PATHway 73 30/11/2016

74 In addition, we will monitor the PATHway solution implementation to ensure compliance with the PATHway Unified Data Model and System Architecture Specification v2 (D4.3) and Use-cases and Function Requirements Definition v2 (D2.5), and that they are fully in adherence with Data Management Plan (D1.3) and the self-audit of DMP (D1.5) with respect to technical and security aspects. The compliance of this will be checked (M24) before the RCT starts /11/2016

75 Annex A 75 30/11/2016