Request for access to EORTC data and/or samples for external research

1. Project identification
Title of the research proposal *
Date of request *
Name of requestor *
Institution(s) where the research will be conducted * Please specify all institutions where (parts of) the research will be conducted (including which data and/or human biological material will be shared with other academic institutions and/or subcontractors and for which purpose).

What is the main scope of your research project ? *  
  if other, specify
What kind of data is requested for the research proposal ? *
 
Does your research make use of or intend to develop a software that falls under EU Medical Device Regulation or Artificially Intelligence Regulation ? * (The newly enforced EU MDR and AI Act applies to processing software intended to provide information for:
diagnosis, prevention, monitoring, treatment, or alleviation of a disease. It applies to software that provides a diagnosis or therapy by itself, but also to software that merely provides information intended to inform a medical professional in making the final diagnostic or therapeutic decision.)


 
  If yes, please clarify:
Does your research qualify as non-commercial research ? * Non-commercial research means that the research proposed is:
- initiated and conducted by an academic entity or a not-for-profit organisation; and
- aimed at dissemination of the results to the public/scientific community; and
- not intended for commercial purposes, i.e., no exploitation of the outcome, no financial gain to the requestor (nor any involved third party), no exclusive rights granted to a commercial partner, no further use of the insights of the research, development, production, or manufacture for commercial purposes; and
- not intended to transfer the intellectual property rights in the results of the research to the funding party, and
- aimed at returning financial means to research.


 
  If no, please clarify:
2. Description of the research project
Background and rationale * Including benefit to patients, science and/or public health

Objectives *
Do you intend to combine the EORTC data with data from other sources (concerning the same study subjects) ?
  If yes, please clarify:
3. EORTC studies involved
EORTC study number(s) (alias and title(s)) Please note that transfer of data from a study that has not been published yet will be deferred until the primary analysis of the requested data has been published.

Was the TR project already submitted to an ethical body ? *  
  If yes, please send a copy of the approval letter (including submission date and name of the ethical body) to datasharing@eortc.org

4. Scientific research leader of the project
  Usually, the clinician or researcher responsible for the project.
This person must sign the request form and agree to follow the Terms of Use.


Name and title *
Institution *
E-mail address *
 
  In case a PhD student or trainee performs the research specify his or her contact details

Name and title
Institution
E-mail address
4.1 Responsible person for the analysis and methodology of the project
  This person must sign the request form and agree to follow the Terms of Use.

Name and title *
Institution *
E-mail address *
Abbreviated Curriculum Vitae of the statistician (This is mandatory. If not provided in the form, please send the CV by e-mail to datasharing@eortc.org)

4.2 Other persons involved in the project
  Please provide information about all person/institutions/companies who will be collaborating with the lead investigator.

Name and title
Institution
E-mail address
Role and responsibilities in the project
Name and title
Institution
E-mail address
Role and responsibilities in the project
Name and title
Institution
E-mail address
Role and responsibilities in the project
5. Description of the statistical methods, analysis plan and design
Description of projects methods and analysis * Please provide details on methods used for primary and secondary analyses.

Description of internal and/or external validation plan Please provide details on how the reproducibility of research project’s findings will be assessed: techniques and assumptions used for internal validation (e.g., split sample, bootstrap…), plan for independent validation.
Please provide the primary and secondary endpoints, available reference values for all endpoints, describe markers prevalence, methods of adjustment for multiple testing or comparison planned, statistical tests or regression models used with significance levels.
Please provide sample size justification and/or power calculation for the targeted effect or desired accuracy.
Detail the methodology and statistical design that will be used for the project, including endpoints and methods.



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6. Timelines
Describe time constraints for your project proposal, if applicable (e.g., grant constraints, publication and/or posting plan)
7. Data specifications
Data format By default, the trial data are transferred to you in the format of a SAS-readable set of files.
However, if you are unable to read that format, please specify an alternative format you prefer (Excel, Text, etc.)


Variables to be transferred (a full list of CRFs and variables can be obtained upon request at datasharing@eortc.org)


If your request is approved, you will be asked to complete a more detailed data transfer specification form.
Please note that EORTC will not update the trial database for any specific purpose of your project.
Please note that in case of Translational Research involving access to and use of HBM and/or data from the EORTC, transfer and use of the HBM and/or data will only occur after TRC-approval and after ethical approval(s) are in place (to be provided by the scientific research leader).
8. Privacy Requirements
Since 25 May 2018, the European privacy legislation is in force: the General Data Protection Regulation (GDPR). Compared to previous legislation, it does not change the principles substantially, but makes a number of new emphases.

Under EU law, sensitive data (like health data) can only be processed if a data protection impact assessment is performed. Specifically, since the data you have requested are regulated under EU law (which follows the data), and since you become Data Controller for use of such data in your Research Project, your Data Protection Officer (DPO) needs to be sufficiently involved in the design of your research plan, at least in assuring compliance to privacy and data protection requirements of the personal data processes associated with your Research Project. Concretely, the aim is to find a pragmatic balance, ensuring an acceptably low risk of re-identification whilst retaining data utility.
To that extent, please provide the following acknowledgements.
8.1a Description of the third parties involved in your research (agreements and roles)
   

  Please, provide any additional information or specific details that may be relevant:

8.1b Description of the Data Transfers outside EU
   
 

  Please, provide any additional information or specific details that may be relevant:

8.2 Description of context related Transparency
   

  Please, provide any additional information or specific details that may be relevant:

8.3 Description of measures taken to ensure Purpose Limitation
   

  Please, provide any additional information or specific details that may be relevant:

8.4 Description of measures taken to ensure Data Minimization
   

  Please, provide any additional information or specific details that may be relevant:

8.5 Description of Data Protection Impact Assessment (DPIA)
   

  Please, provide any additional information or specific details that may be relevant:

8.6 Description of Technical and Organizational Measures (TOMs)
   

  Please, provide any additional information or specific details that may be relevant:

9.Translational Research (TR)
9.1 Data sharing
If your request includes genetic data, you acknowledge that you and your institution shall comply with additional safeguards in connection with the processing of such genetic data, as further specified in the Terms of Use.

OMICs data ? *  
  If yes, specify:

What kind of data and type of file are you requesting ? (Example: raw or process data, DNA sequencing, RNA sequencing, Methylation array, PD-L1 staining, etc.).

For sequencing: any specific gene list or commercial panel ? *  
  If yes, please note that in some cases patients may need to be re-consented.
If yes, please specify which type of molecular data (e.g., gene expression) are required


Do you request these data from ?
  If selected, please describe which patients are targeted.

9.2. Biological Material
9.2.1 Nature and estimated quantity of HBM requested
  Number of slides and thickness (if possible), if other specifications needed (such as anticoagulant used to collect plasma), please specify

Fresh frozen tissue *  
  If yes, please encode the estimated quantity :

FFPE tissue blocks *  
  If yes, please encode the estimated quantity :

FFPE tissue slides *  
  If yes, please encode the estimated quantity :

Blood (serum) *  
  If yes, please encode the estimated quantity :

Blood (plasma) *  
  If yes, please encode the estimated quantity :

TMA (tissue microarray) *  
  If yes, please encode the estimated quantity :

RNA *  
  If yes, please encode the estimated quantity :

DNA *  
  If yes, please encode the estimated quantity :

Other
  If yes, please specify :

9.2.2 Share your data with EORTC
Are you willing to share with EORTC the data generated from the requested samples for further use in other research projects by other researchers ?  
  If yes, could you provide a description of data to be shared with EORTC if feasible?

9.2.3 Principal Investigator of the original trial
Is this project already approved by the Disease Oriented Group and the Principal Investigator of the original trial ? *  
  If yes, please send a copy of the written approval to datasharing@eortc.org

9.2.4 Description of TR methods and analysis plan
Please describe the techniques to be used for the project and provide literature references when applicable * (e.g., DNA/RNA microarrays, quantitative PCR, Fluorescent in situ hybridization (FISH), Comparative genomic hybridization (CGH), Western/Northern/Southern blot, Immunohistochemistry (IHC), ELISA, etc.).
Please provide details on methods used for primary and secondary analysis (if a TR project protocol is available, please send it by e-mail to datasharing@eortc.org and indicate here below):


10. Acknowledgements and Signatures
 

By submitting this data sharing request as final, your signature confirms and acknowledges compliance with the EORTC Policy on Data Sharing, Collection and Use of Human biological material (if applicable) and all obligations and legal requirements defined in the Terms of Use (including the payment of the administrative fee and your responsibilities as a Data Controller in the scope of the presented project).
All are available from: Policies - EORTC

From the research institution  
Scientific leader Name  date  
Methodologist Name  date  

 Use this option if you want to further edit the form later on.

 Use this option when your input is final and you wish to officially submit your request to EORTC (no further modification will be possible).
 
11. Private Notice
Privacy Notice for the persons in charge of the research
This Privacy Notice explains how EORTC will process the Personal Data that you provide as a data sharing Requester about yourself and about other persons involved in the research that you will conduct. This Privacy Notice explains how EORTC collects such Personal Data, for which purposes and with whom EORTC may share it.

What Personal Data will EORTC collect ?
EORTC collects and processes Personal Data about you and other persons involved in the research when completing this data sharing request form. The types of Personal Data that EORTC collects may include the following categories: full name, contact information (i.e., telephone number, e-mail address), information contained in the CV and professional affiliation.

How will EORTC use this Personal Data and with who will EORTC disclose it ?
This Personal Data will be processed by EORTC with the purpose of treating your data sharing request. Furthermore, this personal information may be made available to Disease Oriented Groups (DOGs), former Principal Investigators (PIs) and other collaborative groups involved in the studies from which data is requested, to verify that there is no conflict related to the research project proposal nor any legal or contractual constrains.
EORTC may also be obliged to disclose this Personal Data where required by applicable laws, court orders or government regulation.

What information is relevant about cross border data transfers ?
EORTC may transfer this Personal Data to recipients (EORTC executives, members, experts, partners, collaborators, funders, competent/public authorities, and subcontractors), including recipients outside EU, to countries with less stringent privacy legal framework (such as USA) when required by its activities. EORTC will, when necessary and/or applicable, put in place appropriate safeguards (for example in a form of signed agreements and/or specific technical measures) to protect your privacy and the privacy of other persons involved in the research.

What rights can be exercised concerning this Personal Data ?
Processing of this Personal Data by EORTC falls under the EU General Data Protection Regulation (GDPR) and the Belgian Personal Data Protection Act of 8 December 1992 and its subsequent amendments (Belgian Law). In this scope the following rights can be exercised: request to access your Personal Data and/or to have one copy of it free of charge; request to correct your Personal Data; request the deletion of it; request to receive a copy of the Personal Data provided to us for the purpose of transmitting it to other party(ies); and to object / restrict its processing.

How long may this Personal Data be stored ?
Personal Data will be stored at least 10 years after the data sharing is granted (in case of any claims) or longer periods if required by any applicable legislation.

How to contact EORTC ?
Please, do not hesitate to contact the EORTC Data Protection Officer, shall you or other persons involved in the research have any question in relation to your privacy by sending an e-mail to privacy@eortc.org or by regular mail to EORTC Data Protection Officer av Mounier 83/11, 1200 Brussels, Belgium.

Lodging a Complaint with a Regulator
You or other persons involved in the research have also the right to file a complaint about this Personal Data processing with the data protection authority in your country if you believe it is not handled appropriately.