Page 181 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q009
SOP Title: Integrify® Data Management System
m. ServiceOrderAgreements(SOA)orStatementofWork(SOW) j. Standard Review
D. WhenallservicesareidentifiedontheINTAKEFORM,thecompletedChecklist/ Workbook is attached, along with any other ancillary forms associated with the services being required (e.g., ePSA, Adult Recruitment form, Advanced Analytics QRG, etc). The INTAKE FORM is then ‘submitted’, and the tracking notifications begin.
E. If an error is made on any information on the INTAKE FORM, the QS will contact the Integrify® Administrator who will delete the form and ‘reset’ the form for QS resubmission.
F. Once the INTAKE FORM is submitted, an Integrify® automated email is sent to the study team to notify them to initiate those services with the appropriate research partners, and a copy of the email is sent to the QS team member responsible for reviewing the study.
G. In the Integrify® system, a ‘Task’ for completion is assigned to the appropriate research partner of the Task for each service identified as required.
H. Oncecompletionnotificationsarereceivedfromthestudyteamorresearchpartner for each service required, the Quality Specialist will log into Integrify® and update the system, as needed, until all identified services and ‘Tasks’ are completed.
I. Once all ‘Tasks’ are completed and noted in Integrify®, performance site approval (PSA) can be requested for the study, and the review process is closed.
7. FREQUENTLY ASKED QUESTIONS
See Frequently Asked Question Document
8. PROCESS MAP
(To be copied from workflow map)
SOP No. 26, 07-14-2021; Update 07-28-21; Update 08-03-21; Final 08-11-21