What is it? Why is it important?

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 will be be made available (e.g. study protocol)?
  • How are authorships and acknowledgements defined?

More

Sharing data with other parties requires that the SP-INV, data owner and study participants have given their consent to data sharing.

Consent to data sharing is documented by sharing parties signing the DTA. Participants agreement to have their data shared is documented by them signing the ICF which specifies that collected data will be shared.

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

What do I need to do?

  • Define what data to share
  • Ensure all participants to whom the data belongs have consented to data sharing
  • Define respective responsibilities and obligations regarding data sharing
  • Have an institutional lawyer review the DTA
  • Ensure that the DTA is dated and signed by all partied involved

As a DMan:

  • Prepare the shared data in order to ensure compatibility with the target software system
  • In order to prevent that the data recipient identifies participants ensure that all data is correctly coded before data export
  • Ensure any data transfer is done in a secure and protected environment

More

Data sharing between researchers can be very constructive 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 any patenting ofstudy results. In the event this would be case, conditions for sharing would have to be reviewed as they are expected to be much stricter.

Where can I get help?

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
Abbreviations
  • CTU – Clinical Trials Unit
  • DMan – Data Manager
  • DTA - Data Transfer Agreement
  • ICF – Informed Consent Form
  • 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
Basic Biobanking
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Concept Biobanking
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
Development Biobanking
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 Drug or Device
Set-Up Biobanking
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Conduct Biobanking
Completion

Starts with last study visit completed

Ends after study publication and archiving

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

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