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Statement on decentralized trials

BAREC STATEMENT on decentralized trials

Decentralized elements are trial related actions that are subcontracted by the sponsor to an external party and not offered via the site.

  1. Fully decentralized trials, where there is no contact between the site/PI/treating physician  and the patients included in the trial, are NEVER acceptable.
  2. Decentralization of some trial related actions by sponsors is NOT ACCEPTABLE except in some very specific circumstances whereby the sponsor: 
    1. Submits an explicit motivation with the trial documents why decentralization is needed for some specific parts of this trial
    2. Motivates how patients would benefit from this decentralization (e.g. video calls via a subcontractor to follow-up on the patient’s status …)
    3. Motivates why this decentralization could not be offered by the site
    4. Demonstrates how patient safety (data and physically) is guaranteed
    5. Demonstrates how patient well-being is guaranteed (not being confronted by visits by external people who are not part of the study team)
    6. Demonstrates how GCP standards will be upheld
    7. Guarantees GDPR compliance (and Belgian legislation)

The role of the treating physician, and the patient-physician interaction should be respected.

The participant should always be free in his/her choice to accept the decentralized elements and should be offered equivalent choices. (example, when a patient does not want to be reimbursed for costs via a payment card, they should still be offered the possibility to be reimbursed in via bank transfer). The sponsor should ensure that trial participants and investigators are given the option to have these decentralized elements included. There should be a tick box in the ICF for each decentralized element.

It should be noted by sponsors that would like to offer decentralized elements, that this would require extra effort from the trial site to handle all the options, sufficient financing of the trial should be taken into account. 

The ICF in a trial with decentralized elements should clearly inform the patient about these decentralized elements and offer the participant the option to choose via tick boxes at the end of the ICF. The ICF should also provide all the information on how the subcontractors will handle the personal data of the patient in a clear and understandable way. (for instance: Referring to a link of a privacy policy is not acceptable)

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