25.03.2020
To the attention of Contract Research Organizations
Please be advised on the measures established under Order 74527 / 23.03.2020 issued by Dr Raed Arafat, Action Commander, Secretary of State, Head of the Emergency Department, on establishment of measures required to limit spread of the SARS-Cov-2 virus infection to public and private healthcare facilities, which bears significant impact on the approved clinical trial protocols and implicitly on schedules for patients’ visits to clinical research centres at public and private healthcare sites.
In this context, for the term specified in the above Order (14 days starting with 24.03.2020), scheduled visits of subjects enrolled in clinical trials will no longer be allowed, unless deemed an emergency by the doctor (main investigator) on a case-by-case basis, any delay in the respective case likely to affect the subject’s/patient’s safety.
For all other non-emergency situations, the NAMMDR strongly recommends the following:
– visit rescheduling or replacement with telephone consultations;
– finding solutions for medication delivery to patients at home;
– remote monitoring;
– delay initiation of new clinical trials or new research centres.