Data Sharing / Access to HBM or Images Request form

Project identification
Project title
Date of request
Name of requestor
Institution where the research is conducted
What is the main scope of your project
  if other, specify
1 Description of the research project
Background/rationale of the project
Objectives of the project
2 EORTC trials involved
EORTC study numbers (or titles)
3 Persons in charge of the research outside the EORTC Headquarters
3.1 Scientific leader of the project
 

Usually the clinician or researcher responsible for the project,
This person must sign the request form

Name and title
Institution
e-mail address  
  In case the research is performed by a PhD student or trainee specify his contact details
Name and title
Institution
e-mail address
3.2 Responsible person for the data analysis and methodology of the project
  This person must sign the request form
Name and title
Institution
e-mail address
Abbreviated Curriculum Vitae of the statistician (or send CV by e-mail to datasharing@eortc.be)
3.3 Other persons involved 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
Name and title
Institution
e-mail address
Role and responsibilities in the project
4 Persons involved in the project at the EORTC Headquarters (if applicable)
Name and title
Responsibilities
Time required and degree of involvement
Name and title
Responsibilities
Time required and degree of involvement
5 Statistical methods and analysis plan
  Detail here the methodology that will be used for the project, including endpoints and methods (if a project protocol is available, please send it by e-mail to datasharing@eortc.be and indicate herebelow)
 
6 Practical details of the project
6.1 Timelines
  Indicate expected timelines of the project.
Data analysis
First publication of results
Expected completion date
6.2 Financing
  If applicable specify any financial resources that are available to cover the project costs
 
6.3 Data specifications
 

By default, the trial data are transferred to you in the form 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..)

Specify here which variables you need. Indicate “all data” if you need the complete database
(If specific coding is required, please send specifications by e-mail to datasharing@eortc.be )

Please note that the EORTC will not update the trial database for any specific purpose of your project

Please note that in case of TR project, transfer of clinical data will occur only after TRAC and ethical approvals for access to and use of HBM are in place

Format of transfer file,
if different from SAS
Variables to be transferred
6.4 Other conditions on the data transfer, if the request includes trials the final results of which are not yet published
  If applicable, specify here if data is requested for trials that have not yet been published. In this case, the data transfer of these trials will  be deferred until the trial results are published.
 
7 Translational research (TR)
7.1 Human biological material
Was the TR project planned in the trial protocol
Has this project been approved
by the steering committee of the original trial and the EORTC group ?
  if yes, please send a copy of the written approval to  datasharing@eortc.be
 

e.g. FFPE tissue blocks or slides, frozen tissue, plasma, serum, etc.

Nature of material requested
Amount of material needed (or available if known)
Is the material already centralized
  if yes, please specify name and location of central lab:
7.2 Experimental techniques
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.):
7.3.1 Description of TR statistical design
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:
7.3.2 Description of TR methods and analysis plan
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.be and indicate here below):
7.3.1 Description of internal and/or external validation plan
Please provide details on how the reproducibility of TR project findings will be assessed: techniques and assumptions used for internal validation (e.g. split sample, bootstrap…), plan for independent validation (follow-up trial…):
7.4 Ethics
Was the TR project already submitted to an ethical body?

if yes, please send a copy of the approval letter to datasharing@eortc.be
Date of submission
Name of the ethical body
7.4 Third party
Please indicate if there is any third party involved in this project (company, collaborating group, etc.)
8 Publications
8.1 Expected publications resulting from the research project
 

Indicate the number of publications that you anticipate and for each of them, the subject of the publication

Number of publications anticipated
Subject of the publications (list)
8.2 Authorship for EORTC representatives
  By default, the EORTC does not claim authorship positions on papers resulting from your research. However, if one or several positions should be attributed to EORTC members, please indicate them below.
 
8.3 Approval of Terms of Use

Please approve the Terms of Use

   
9. Signatures
9.1 Agreement from the requestor and methodologist
 

The undersigned approves the present project and release of the EORTC data under the conditions set in EORTC Policy 008 “Release of data from EORTC studies for use in External Research Projects”

and EORTC POL 014 "Translational Research Advisory Committee (TRAC)" and EORTC POL 020 "Human Biological material collection storage and use
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 (no further modification will be possible)