Page 126 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q001
SOP Title: Research Department Mailbox Process
The email notifications will then be moved into the Study Approved share folder under Research_Department Inbox.
• CMC – Study Approved (Refer to SOP No: 8 Study Approved – CMC as a Clinical Site for more details) - Member of the Quality Specialists team will continually track logged studies listing Children’s as a Performance Site and will follow-up with those investigators who have not requested a Performance Site Review in Velos.
• Children’s Medical Center Site Approval (PSA) Request (Refer to SOP No: 3 Performance Site Approvals Process for more details) – Quality Specialists will process the requests for site approval. Upon PSA approval by Children’s Medical Director, the email notifications will be moved into the PSA Notifications share folder under Research_Department Inbox.
• CMC – Notice of Study Lapse (Refer to SOP No: 2 Lapsed IRB Study Process for more details) - A member of the Quality Specialists team will verify if continuing review has been submitted and approved by IRB. For projects in which the researcher has not initiated a continuing review request in the eIRB, a lapsed letter notification will be emailed to the researcher within 3 business days of CMC Research Administration being notified of the study lapse in the Research Mailbox.
• CMC–ModificationSubmitted–“MODSubmitted”notificationswillbereviewed in real time. Quality Specialist team members or designee will only log and track MOD submitted type that involve updates to the protocol. Depending on the change, service order agreement (SOA) may also need to be amended. Quality Specialist team members or designee will notify the researcher and CMC key stakeholdersregardinganupdatetotheSOA. ForallotherMODsubmitted notificationtypes(personnel,consent/HIPAA,recruitment,other),Quality Specialist team members or designee will delete these e-mail notifications from the eIRB.
• Annual Updates & Continuing Review – CMC Review - At the end of each business day, these emails will be deleted.
• Annual Updates & Continuing Review – Acknowledgment Notices – At the end of each business day, these emails will be saved under the folder titled “Annual Updates & CR Approval E-Mails
• Data Analytics Correspondence – Data Analytics requests are now being housed in their own general e-mail box called “Research-Data Requests”.
• Reportable Event Notifications – Review and file all HRPPO RE notifications. Forward HRPPO RE notifications (if an SAE occurred at Children’s) to RA Administration for acknowledgement.
• Study Closure – Once a notice of closeout is received, QS will forward notice to assigned RA finance team member (base on alpha list) to ensure that all billing has been completed.
SOP No. 5, Date: 4/13/16; 10/13/16; 03/19/2019; 02/20/2020