Replacing face-to-face study visits with phone calls is acceptable where appropriate. Documentation of the phone call should be kept, as this will constitute source data. This is allowed on a temporary basis, for as long as the outbreak prevents face-to-face visits.
Participants should not be included in a trial unless you can confirm they meet the inclusion and exclusion criteria. Similarly, if the safety of a participant is at risk because they cannot complete key safety checks, you must consider whether to withdraw that participant. Where necessary, urgent safety measures may be implemented first followed by a subsequent substantial amendment, as outlined in question 6. You should also consider whether it is appropriate to temporarily halt recruitment (see question 17), or the study as a whole (see questions 18, 19, 20).
Handling changes to participant visit methods/frequency should be handled as follows.
Non-CTIMPs where the changes will not impact participant safety
Submit a non-substantial amendment to the Research Governance, Ethics & Assurance Team for authorisation and include the amendment tool and tracked and clean copies of all amended documents.
After sponsor authorisation, submit to HRA via their online submission portal and at the same time send the documentation to your sites.
Non-CTIMPs where the changes will impact participant safety
This requires a substantial amendment, which will receive expedited review by the Research Governance, Ethics & Assurance Team and relevant regulators. When you submit to the Research Governance, Ethics & Assurance Team, please note in the subject header that the amendment is COVID-19 related.
Changes to visit methods and/or frequency should be risk assessed, notified to the Research Governance, Ethics & Assurance Team, and documented in the Trial Master File along with a record of any protocol deviations. In the current circumstances, a formal amendment is not required for CTIMPs to implement these changes, and they will not be considered a serious breach of the protocol.