Completion↦Data Handling↦Data Export↦Data Transfer Agreement
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?
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
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
Basel, Departement Klinische Forschung, CTU, dkf.unibas.ch
Lugano, Clinical Trials Unit, CTU-EOC, www.ctueoc.ch
Bern, Clinical Trials Unit, CTU, www.ctu.unibe.ch
Geneva, Clinical Research Center, CRC, crc.hug.ch
Lausanne, Clinical Research Center, CRC, www.chuv.ch
St. Gallen, Clinical Trials Unit, CTU, www.kssg.ch
Zürich, Clinical Trials Center, CTC, www.usz.ch
ICH-GCP E6(R2) – see in particular guidelines
- 5.5. Trial management, data handling, and record-keeping