External application form - Stakeholders

EUCAIM stakeholders: application for data incorporation use cases

Please read the Background Information before proceeding to questions.
Background Information:

Pre-Requirements (if not done yet):
- Complete the TIERs Maturity Level Questionnaire
- Complete the Expression Of Interest
Definitions of TIER 1, 2 and 3:
- Tier 1: The datasets hosted by the federated node are registered in the central catalogue. Users can explore the metadata of the datasets registered in EUCAIM’s platform.
- Tier 2: The data of the federated node is searchable through its local searching service, which is queried by the federated search system. The users can explore the actual number of studies fulfilling the search criteria defined by the user.
- Tier 3: The federated node has a materialisation component that makes the data available to the federated processing, according to EUCAIM’s model. The user will be able to run processing actions on the actual data, if the access to them is granted.
Onboarding process overview:

More information:
Contact Details

Organization
Organisation's name*
Organisation's Acronym*
PIC*
Organisation type*

HospitalRepositoryUniversityResearch CentrePatients' AssociationSmall or Medium Enterprise (SME)Large CompanyProfessional SocietyInfrastructure (EDIC, ERIC, etc.)Government OrganisationOther
Contact Person (PI)
Title*
Name*

First NameLast Name
ORCID/Other IDs*
Gender*
Phone Number (please include country code):*
Email*
example@example.com
Department*
Address*

Street Address

Street Address Line 2

CityState / Province

Postal / Zip Code
Country*
Other contacts in the Organization
Please indicate the contact person, or the unit represented by a natural person, that has been assigned the appropriate legal representation (name, e-mail address, position):*

0/600
Please provide the details of your Data Protection Officer:
Name

First NameLast Name
Email
example@example.com
Position:
Governing unit/section/body
Scientific background of the applicant
Please provide a short description of your Institute and its main activities, including collaborative networks you are involved in:*
Please list ongoing and completed projects which are related to your use case:*
Please upload a short CV of the PI (max 2 pages) in the “supporting documentation” section (tick for acceptance):*

Accept
Type of contribution and maturity level

Please indicate that you are applying to contribute with data (data holder).
I am applying with the intention to ...*

... contribute with data (Data Holder)
Please specify if data will be shared through the EUCAIM central repository or through a federated node (Data Holders Handbook, section 6.1. "Reference nodes", section 7. "Setting up a Federated Node"):*

Central Repository (UPV reference node)Central Repository (Health-RI reference node)Federated Node
If you are applying to become a federated Node of EUCAIM, and your application is successful, you will be required to provide additional technical information (tick for acceptance)*

Accept
Please indicate the level of compliance with the EUCAIM Data Federation Framework (see Data Holders Handbook, section 5. "Requirements for Tier 1, 2 and 3"):*

data compliant with Tier 1 of EUCAIM Data Federation Frameworkdata compliant with Tier 2 of EUCAIM Data Federation Frameworkdata compliant with Tier 3 of EUCAIM Data Federation Framework
Please indicate the level of compliance with the EUCAIM Data Federation Framework that you plan to reach by the end of the project?*

data compliant with Tier 1 of EUCAIM Data Federation Frameworkdata compliant with Tier 2 of EUCAIM Data Federation Frameworkdata compliant with Tier 3 of EUCAIM Data Federation Framework
Is the dataset you are going to provide created as a closed existing collection or is it still ongoing?*

Dataset already created.Dataset not created yet/ongoing.
Scientific relevance of your participation in EUCAIM as a data holder
General description of the potential use and clinical impact of the shared data (max 600 words)*

0/600
Which types of data can be made available?

Only imaging data and only the minimum clinical information (age at diagnosis or (birth year and year of diagnosis), sex, topography (site), morphology (histology), number of days between the imaging procedure and the tumor incidence) (mandatory)Imaging and other data (e.g. other clinical variables) required for answering the specific use case (please specify which other data)Image Annotations (format, description and labelling) (if available)
If you picked "Imaging and other data" please specify which other data can be made available:

0/300
Please describe your imaging datasets. In case you have data for multiple cancer types (multiple datasets), please provide the information separately for each type.
Dataset 1
Cancer Type*
General Metadata:
Dataset name:*
Please describe the dataset*

0/300
Dataset Collection Method:*
Dataset Type*
Dataset Terms of Use
Dataset Intended Purpose*
Imaging and Clinical (or Other) Metadata:
Imaging Modality:*
Vendor
Imaging body part
Age range*
Sex*
Number of subjects*
Number of DICOM studies (if relevant)
Image size in GB (if available)
De-identification. Please select which of the following statements applies for your dataset.*

Personal data is included in the images. In this case EUCAIM can support you with specific tools and guidance for de-identification once the application is accepted.Personal data is pseudonymisedPersonal data is de-identified (direct identifiers have been removed)Personal data is fully anonymised
Please state whether the data sets you are providing (if applicable):

are held by more than one legal entity or by more than one data holderare from more than one country in the EU
Do you have more datasets to provide?*

Yes, proceed to questions about the next dataset.No.
Dataset 2
Cancer Type
General Metdata
Dataset name:*
Please describe the dataset*

0/300
Dataset Collection Method:*
Dataset Type*
Dataset Terms of Use
Dataset Intended Purpose*
Imaging and Clinical (or Other) Metadata:
Imaging Modality*
Vendor
Imaging body part
Age range*
Sex*
Number of subjects*
Number of DICOM studies (if relevant)
Image size in GB (if available)
De-identification. Please select which of the following statements applies for your dataset.*

Personal data is included in the images. In this case EUCAIM can support you with specific tools and guidance for de-identification once the application is accepted.Personal data is pseudonymisedPersonal data is de-identified (direct identifiers have been removed)Personal data is fully anonymised
Please state whether the data sets you are providing (if applicable):

are held by more than one legal entity or by more than one data holderare from more than one country in the EU
Do you have more datasets to provide?*

Yes, proceed to questions about the next dataset.No.
Dataset 3
Cancer Type
General metadata
Dataset name:*
Please describe the dataset*

0/300
Dataset Collection Method:*
Dataset Type*
Dataset Terms of Use
Dataset Intended Purpose*
Imaging and Clinical (or Other) Metadata:
Imaging Modality*
Vendor
Imaging body part
Age range*
Sex*
Number of subjects*
Number of DICOM studies (if relevant)
Image size in GB (if available)
De-identification. Please select which of the following statements applies for your dataset.*

Personal data is included in the images. In this case EUCAIM can support you with specific tools and guidance for de-identification once the application is accepted.Personal data is pseudonymisedPersonal data is de-identified (direct identifiers have been removed)Personal data is fully anonymised
Please state whether the data sets you are providing (if applicable):

are held by more than one legal entity or by more than one data holderare from more than one country in the EU
Do you have more datasets to provide?*

Yes, proceed to questions about the next dataset.No.
Dataset 4
Cancer Type
General metadata
Dataset name:*
Please describe the dataset*

0/300
Dataset Collection Method:*
Dataset Type*
Dataset Terms of Use
Dataset Intended Purpose*
Imaging and Clinical (or Other) Metadata:
Imaging Modality*
Vendor
Imaging body part
Age range*
Sex*
Number of subjects*
Number of DICOM studies (if relevant)
Image size in GB (if available)
De-identification. Please select which of the following statements applies for your dataset.*

Personal data is included in the images. In this case EUCAIM can support you with specific tools and guidance for de-identification once the application is accepted.Personal data is pseudonymisedPersonal data is de-identified (direct identifiers have been removed)Personal data is fully anonymised
Please state whether the data sets you are providing (if applicable):

are held by more than one legal entity or by more than one data holderare from more than one country in the EU
Do you have more datasets to provide?*

Yes, proceed to questions about the next dataset.No.
Dataset 5
Cancer Type
General metadata
Dataset name:*
Please describe the dataset*

0/300
Dataset Collection Method:*
Dataset Type*
Dataset Terms of Use
Dataset Intended Purpose*
Imaging and Clinical (or Other) Metadata:
Imaging Modality*
Vendor
Imaging body part
Age range*
Sex*
Number of subjects*
Number of DICOM studies (if relevant)
Image size in GB (if available)
De-identification. Please select which of the following statements applies for your dataset.*

Personal data is included in the images. In this case EUCAIM can support you with specific tools and guidance for de-identification once the application is accepted.Personal data is pseudonymisedPersonal data is de-identified (direct identifiers have been removed)Personal data is fully anonymised
Please state whether the data sets you are providing (if applicable):

are held by more than one legal entity or by more than one data holderare from more than one country in the EU
Additional comments:
Ethical and legal requirements
Please select which of the following options applies:*

A certificate of ethics approval by an ethics committee is required for sharing data with EUCAIMNo approval by the ethics committee is required.
If a certificate of ethics approval is required, please select the option that applies:*

You have already applied for an ethics approval from an ethics committeeNo action has been taken yet to obtain an ethics approval from an ethics committee
If you are willing to contribute data to the EUCAIM Infrastructure, please select which of the following options applies:*

You are able to demonstrate the due diligence in complying with the GDPRYou are currently not yet able to demonstrate the due diligence in complying with the GDPR, but are working towards it.You are not able to demonstrate the due diligence in complying with the GDPR and have not started working on it yet.
You are able to demonstrate the due diligence in complying with the GDPR by:*

A certification or statement issued by your Data Protection OfficerA Data Protection Impact Assessment report or independent audit.Membership of codes ofconduct or certification schemes or equivalent documentation.
Indicate whether the dataset(s) you will provide are subject to any restrictions on use defined by the data holder or general legislation.

YesNo
If you answered yes, please describe the restrictions:
If you are providing third party datasets, please describe any documentation you have already available for demonstrating the compliance with GDPR regulation (e.g. Privacy Policy, Data Sharing Agreements)
You understand that your entity will necessarily enter into a data sharing agreement (federated nodes) or a data transfer agreement (datasets located at EUCAIM premises) with the EUCAIM Project by providing appropriate safeguards. (tick for acceptance)*

Accept
Please confirm that you have duly informed and obtained authorization from the person, unit, or body with the legal capacity to decide and represent your institution in this matter. By proceeding, you acknowledge that formalizing these agreements requires you to provide all necessary documentary evidence demonstrating compliance with applicable legal and ethical requirements. (tick for acceptance)*

Accept
Additional comments:
Technical details, capabilities and functionalities
Does your data follow any standard data model? If yes, please specify which data models (e.g. OMOP-CDM)?*

YesNo
If yes, please specify*
Does your data follow the HL7 FHIR standard for exchange purposes?*

YesNo
Have you adopted any standard vocabularies and terminologies to describe your data (e.g. SNOMED-CT, ICD-10 etc.)? If yes, please specify which ones. If no, EUCAIM can support you with specific tools and guidance once the application is accepted.*

YesNo
If yes, please specify:*
Does your organization store any type of image data annotations (i.e., image segmentations)?*

YesNo
If yes, please indicate the format (i.e. NIFTI, DICOM-SEG…):
What is your estimated time needed to finalise dataset preparation for data imaging extraction and clinical data (see Data Holders Handbook, section 5.1 "Data Preparation")?

0-3 weeks1-2 months3-4 months>4 months
Where do you anticipate the main challenges or bottlenecks in terms of technical implementation, and why? e.g. dataset preparation
Will you need some support from EUCAIM on data preparation (anonymisation, quality checking, data modeling, metadata definition, etc. - see Data Holders Handbook, section 5.1 "Data Preparation")?

YesNo
If yes, please specify in which areas do you expect to need the most support from EUCAIM?
Do you have in-house technical staff available to dedicate to dataset preparation? Please provide more details about the staff available and dedicated time per week.
What is your availability for regular follow-ups?

WeeklyBiweeklyMonthlyOther
Additional comments
Supporting documentation

Please upload the following documentation:
CV of the PI*

Cancelof
Certificate of ethics approval issued by an ethics committee if already available

Cancelof
Documents demonstrating the due diligence in complying with the GDPR if already available. This may be evidenced by Data protection Impact Assessment reports, independent audits, membership of codes of conduct or certification schemes or equivalent documentation

Cancelof
Completed ownership control assessment questionnaire (please find a link to download the questionnaire at the bottom of this form)*

Cancelof
Any other documentation you deem useful for the evaluation of your application

Cancelof
Any documents which may be required and which are not available at the time of completion of this form must be provided at the time your application is successful or at such other time as may be required under applicable law.
Estimated timeline for completing the missing legal documentation (see Legal Handbook):*

0-2 months2-4 months4-6 months>6 months
Do you foresee any major obstacles to completing the missing legal documentation? Please include an example if available, based on your experience in other similar projects:
Download the ownership control assessment questionnaire here: https://ec.europa.eu/info/funding-tenders/opportunities/docs/2021-2027/common/temp-form/af/ownership-control-declaration_en.docx
The information disclosed by the applicants will be kept confidential, shall be used exclusively for participation in the Call (e.g. for the evaluation by the Access Committee),and will remain the sole property of the Participants. Intellectual Property developed by the Participants is exclusively owned by the Participants and any development resulting from participation in the Call that may be (or not) protected by IPR (meaning the "Results") will be owned solely by the Participants.*

Accept
Consent*

By submitting this form, I agree that my personal data will be electronically processed for the purpose of the EUCAIM internal call for use-cases. I agree that my contact details will be shared with cooperating partners if necessary for additional updates about the project.
EIBIR, as managing partner, will process your data in order to evaluate your application. To exercise your data protection rights and to know the full terms and conditions of the processing, please see our terms and conditions and our privacy notice.

By completing this form, you are providing consent for us to process your information for the EUCAIM data incorporation use cases. Your data will be used exclusively to assess your application and send you relevant updates. You can opt-out at any time. You have the right to access, rectify, object to, and erase your personal data at any time. To exercise these rights or to obtain more information on how we handle your data, you can contact the project coordinator EIBIR at contact@cancerimage.eu.
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EUCAIM stakeholders: application for data incorporation use cases

Background Information:

Pre-Requirements (if not done yet):

Definitions of TIER 1, 2 and 3:

Onboarding process overview:

More information:

Contact Details

Scientific background of the applicant

Type of contribution and maturity level

Scientific relevance of your participation in EUCAIM as a data holder

Dataset 1

Dataset 2

Dataset 3

Dataset 4

Dataset 5

Ethical and legal requirements

Technical details, capabilities and functionalities

Supporting documentation