Was betrifft es? Warum ist das wichtig?

The Data Transfer Agreement (DTA) is a contract between a given data holder and data recipient. The DTA contains details on the accepted use of the data, including applicable legal obligations and restrictions.

 

The DTA defines:

  • What type of data will be shared?
  • When will the data be made available and for how long?
  • Who will be given access to the data and under what conditions?
  • Will additional documents be made available (e.g. study protocol)?
  • How are authorships and acknowledgements defined?

 

Sharing data with other parties requires that the SP-INV, if applicable Site-INV, and study participants have given their consent to data sharing. Consent to data sharing is documented by sharing parties signing the DTA.

 

When sharing data the SP-INV and Site-INV can request different types of compensation such as licence, authorship, and acknowledgement.

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Participant agreement to data sharing is documented in the ICF. Here data sharing is explained to participants who have to agree by signing and dating the document. Participants retain the right to withdraw their consent on data sharing. If applicable, special procedures apply.

 

Was muss ich befolgen?

As a SP-INV

  • Based on data sharing request, agree with recipient on what data to share
  • Ensure all participants to whom the data belongs have consented to data sharing
  • Define and document respective data sharing responsibilities and obligations in the DTA
  • Have an institutional lawyer review the DTA
  • Ensure that the DTA is dated and signed by all partied involved

 

As a study Data Manager:

  • Prepare the data to be shared so as to ensure compatibility with the target software system (e.g. data formatting)
  • Code data accordingly in order to prevent that the data recipient can identify participants 
  • Transfer the data in a secure and protected environment (e.g. make no transfers by e-mail)

 

Safe transfers include special web services that incorporate an encryption algorithm in the data. Secured-file-transfer-protocol hosted by institutional servers. A CDMS with secure uploading and file sharing functionalities.

Mehr

Data sharing between researchers can be highly profitable as:

  • External experts can contribute to the objective analysis and interpretation of study results
  • Study data can be made available to the research community encouraging knowledge sharing
  • Study data becomes efficiently utilised improving the overall cost/benefit ratio of the study
  • Based on ethical principles ensure that no study data remains unused, but is made available for interpretation and subsequently to the public

 

Your legal advisor will determine whether conditions are met regarding the patenting of study results. If so, conditions for sharing must be reviewed as conditions are expected to be much stricter.

Wo kann ich Hilfe anfordern?

Your local CTU can support you with experienced staff regarding this topic

*References

ICH-GCP E6(R2) – see in particular guidelines

  • 5.5. Trial management, data handling, and record-keeping

Swiss Laws

HRA - see in particular article

  • Art. 7 Consent

ClinO - see in particular article

  • Art. 7c Information
Abkürzungen
  • ClinO – Clinical Trials Ordinance
  • CTU – Clinical Trials Unit
  • DTA - Data Transfer Agreement
  • HRA – Human Research Act
  • ICF – Informed Consent Form
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • Site-INV – Site Investigator
  • SP-INV – Sponsor Investigator
Completion ↦ Data Handling ↦ Data Export ↦ Data Transfer Agreement
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Current Path (click to copy): Completion ↦ Data Handling ↦ Data Export ↦ Data Transfer Agreement

Please note: the Easy-GCS tool is currently under construction.