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Reply to: Direct to PatientMarch 27, 2020 at 4:10 pm
An item to consider, although the regulators are putting in place some allowances for DtP shipments, the sponsor does retain the accountability for ensuring that the protocol they are considering using it for are able to be managed by the patient without medical oversight or that they’ve put in place the required support. Protocol amendments may be needed and any lab works – particularly if it is related to safety/ levels of meds, would still need to be carried out. Although some of our study teams are celebrating at news of the temporarily relaxed regulations, there are still lots of items to manage by the sponsor prior to implementing in order to ensure the quality of product and safety of patients.