Two SOPs will be effective on 06 November 2023: “Participant Study Drug Shipment and Return” and “Consenting Research Participants and Legally Authorized Representatives”.
Training for these SOPs have been assigned in STARS to relevant staff members. If you received an enrollment email from STARs to complete CCTO-0314 and CCTO-0302, please login to STARs and complete the training module before 19 November 2023. Completion of the training is required within 30 days of assignment. Instructions for completing the training can be found on the enrollment email; please follow the instructions carefully to ensure you progress and completion of the training is saved and documented. If you did not receive an enrollment email, you are excluded from this training requirement.
CCTO-0314: “Participant Study Drug Shipment and Return” is a NEW SOP outlining the procedures necessary for sending study drugs to participants via mail, including approvals required, packaging instructions, and patient materials.
CCTO-0302: “Consenting Research Participants and Legally Authorized Representatives” is the version 3 update of the existing SOP. The update encompasses English consents, non-English consents, and remote consenting.
Should you have any questions regarding the courses please contact: firstname.lastname@example.org.
Please direct all questions regarding issues with STARS to the STARS support team via the link available in the enrollment email.