E-QUALITY TERMS AND CONDITIONS FOR UR-CARE USERS
E-QUALITY TERMS AND CONDITIONS
BY AND BETWEEN:
ECCO as initiator of the project (with IBDIM as research unit of ECCO being contracted as IT service provider/supplier due to established UR-CARE platform), having its place of business at Ungargasse 6/13, 1030 Vienna, Austria, Austrian Association Registry Nr. 468755685, hereinafter referred to as “ECCO“
the undersigning Individual Participant Centre, who is bound by the electronic confirmation of these terms and conditions by its representative confirming the set-up of this account hereinafter referred to as “Individual Participant Centre”
both hereinafter, jointly or individually, referred to as “Parties” or “Party”
relating to the Project entitled: E-QUALITY
Point 1: Purpose
The purpose of the E-QUALITY project is to identify gaps between quality standards as defined by ECCO and current practice in daily clinical care by asking Individual Participant Center to answer questions and to provide statistical data to enable ECCO to conduct statistical analyses.
The E-QUALITY project will be structured in two or more phases. In the first phase, the Individual Participant Center will be asked by ECCO to answer questions on the structure of the Individual Participant Center itself. In the second phase, the Individual Participant Center will be aksed by Ecco to answer questions on patient care and to provide anonymous statistical institutional data on patient care.
The answers and anonymous statistical institutional data in the project phases will be entered by Individual Participant Centres into a secure digital platform offered by a qualified e-Health IT company, contracted by IBDIM in it’s role as IT-Provider and Sub-Processor of IBDIM.
Point 2: Preliminary Conditions for the E-QUALITY Account
Any Individual Participant Centre in the UR-CARE Platform can request that the E-QUALITY project is added to the UR-CARE administrator account of the respective institute.
By requesting such an addition of the E-QUALITY project to the UR-CARE account, the Individual Participant Centre agrees with these terms and conditions based on their careful review.
On behalf of the Individual Participant Centre the System administrator can introduce / nominate other team members to have access to the platform.
• The E-QUALITY User has access to the platform in compliance with all confidentiality regulations.
• User data which is part of the individual user profile used to create an access to the E-QUALITY account includes name, email address, institute and institute address of the E-QUALITY Account User. The personal data is needed for the management and fulfilment of the contractual relationship between the registered user and ECCO.
Each Party keeps its contact details on the E-QUALITY platform up-to-date, including all user profiles.
The user can exercise their rights of access, rectification, erasure, limitation of processing, portability and revocation of consent in relation to the personal data obtained from the broader UR-CARE platform by contacting ECCO.
Point 3: Institutional Data shared with E-QUALITY Project
ECCO is conducting a long-term project to identify the gaps between the quality standard of care proposed in our recent position paper and the actual situation in different countries affiliated to ECCO.
It is a principle of sovereign decision that an Individual Participant Centre can choose in which project and project phase it would like to participate.
A E-QUALITY Individual Participant Centre will not be able to see the institutional data of another E-QUALITY Individual Participant Centre – except aggregated statistical reports.
3.1. Data entry
In the course of the project, participant centres will be invited to share their institutional data in reply to specific survey questions on the management of IBD (structure, processes, outcome measures as listed in the ECCO Quality of Care Position Statement)
a) Stucture : institutional survey answers
b) Processes and outcome: statistical answers on domains of investigation
The current project will be an umbrella of statistical data collection rounds aimed to investigate particular aspects of some general domains. These domains will be:
• Diagnostics and Monitoring of IBD
• Assessment and Treatment of IBD
• Nutrition and Surgery in IBD
3.2. Controllership of data submitted to the project
By submitting answers to the E-QUALITY quality, the Individual Participant Centre gives permission that these answers can be assessed, analysed, summarised and published in the framework of the project.
a) Structure : institutional survey answers → the Individual Participant Centre will be acknowledged in the respective website report and in the appendix of the publication.
b) Processes and outcome: statistical answers on domains of investigation → Any acknowledgement in addition to the respective website report and in the appendix of the publication will be announced in the respective invitation for respective statistical questionnaire.
3.3. Compliance (for data transfer, collection and management)
Data entry of institutional data and institutional statistical answers for the E-QUALITY Project is based on the agreement to these terms and conditions in the set-up process of the project account on behalf of the institute.
Each Party shall ensure that its participation in the E-QUALITY complies fully with all applicable local, national and international laws, regulations and guidelines. In particular, the Individual Participant Centre will provide only fully anonymized patient care data and will take care that any patient care data uploaded to the digital platform does not contain any personal or personal identifiable patient data.
In the event that any part of these terms and conditions is determined to violate applicable laws and regulations, ECCO will aim to update these terms to bring them entirely into compliance.
3.4. System ownership
The Sub-processor of IBDIM providing the digital platform is the owner of the ClinicaaL® system and of all the system modules, applications, platforms and database structures, and this is expressly recognized by the Individual Participant Centre.
Point 4: Interactions with Industry
ECCO reserves the right to ask its Corporate Partners for project funding via unrestricted grants – which do secure scientific independence and no request for content of involvement beyond a preview of preliminary reports, which are scheduled for publication.
Point 5: Financial provisions
ECCO is funding the project and the institutional accounts are offered for free.
In turn, no financial obligations of ECCO to E-QUALITY Individual Participant Centre will be established in return for E-QUALITY project participation.
Point 6: Project duration and termination
Duration and termination: to enable several phases in the E-Quality project and to compare information provided over time, all answers to questions and statistical data provided by the Individual Participant Center will be stored for a period of 7 years.
Point 7: Responsibilities of Parties / Obligations
7.1. General principles
Each Party undertakes to cooperate, perform and fulfil, promptly and on time, all of its obligations according to this Contract.
Each Party undertakes to notify the other Party promptly about any significant information, problem or delay.
Each Party is responsible for the validity, accuracy and confidentiality of the data transferred to the other Party / Parties and in case of gross negligence or wilful acts shall be liable towards the other Party / Parties for damages resulting from a breach of this provision.
7.2. Data protection & Non-disclosure of information
ECCO and its processor IBDIM will commission (sub-)processors for the E-QUALITY procect, in particular IBDIM will commission the following sub-processors:
1. Name: Persei Vivarium
Address: Gran Vía, 62, 28013 - Madrid (Spain)
Contact person’s name, position and contact details: Miguel Cabañas, CTO and DPO,
Description of the processing (including a clear delimitation of responsibilities in case several sub-processors are authorised): IT Service Provider
2.Name: Rapid Mail
Address: rapidmail GmbH, Wentzingerstraße 21, 79106 Freiburg im Breisgau, Germany
Point 8: Liability towards each other
8.1. Authorization and Notification
Each Party represents and warrants that it has full right and authority to enter into this Contract under any law, regulation or policy applicable to it.
8.2. Breach of contract
If a Party breaches the Contract, it is liable for the consequences.
In case of incorrect data entry by Individual Participant Centre, ECCO cannot be held liable. The Individual Participant Centre assumes full responsibility for its data entry.
8.3. Force Majeure
No Party shall be considered in breach of this Contract if it is prevented from fulfilling its obligations under this Contract due to a force majeure event.
Each Party will notify the other parties of any force majeure without undue delay. If the consequences of force majeure for the subject matter of this Contract are not overcome within 6 weeks after such notification, the transfer of tasks - if any - shall be decided by the Parties.
Point 9: Miscellaneous
9.1. Inconsistencies and severability
Should any provision of these terms and conditions become invalid, illegal or unenforceable, it shall not affect the validity of the remaining provisions. In such a case, the Parties concerned shall be entitled to request that a valid and practicable provision be negotiated which fulfils the purpose of the original provision.
9.2. No representation, partnership or agency
No Party shall be entitled to act or to make legally binding declarations on behalf of any other Party. Nothing in this Contract shall be deemed to constitute a joint venture, agency, partnership, interest grouping or any other kind of formal business grouping or entity between the Parties.
9.3. Applicable law
The applicable law is Austrian law.
9.4. Settlement of disputes
The Parties shall endeavour to settle their disputes amicably.
As a last resort, the dispute shall be finally settled under the Rules of Arbitration of the International Chamber of Commerce by one arbitrator appointed in accordance with the said Rules. The Emergency Arbitrator Provisions shall not apply. The place of arbitration shall be Vienna, Austria. The language of the arbitration shall be English.