For studies that require DSMC monitoring and involve administration of investigational products (IP):
Starting November 1, 2022, signed drug orders for oral IP will be requested as part of the study monitoring.
Starting January 1, 2023, signed drug orders for any IP, regardless of type (oral, topical, intravenous, radiopharmaceutical, other), will be requested as part of the study monitoring.
Of note, if your study utilizes Beacon for investigational drug orders, please indicate that in the monitoring questionnaire. In which case, you do not need to provide the drug orders, if you are able to confirm that the drug orders are available in Beacon.
We ask that all drug orders are provided for the patients selected for monitoring. This change will be reflected in the monitoring requests that are sent out. If you have any questions or concerns, please reach out to our quality monitors at firstname.lastname@example.org