Page 180 - CHST Research Adminstration eBook 2 of 2 (Q4 2021)

STANDARD OPERATING PROCEDURE Research Administration SOP No: Q009
SOP Title: Integrify® Data Management System
4. SCOPE
This SOP applies to all departments conducting research at Children’s Health.
5. RESPONSIBILITIES
When a new study submitted notification for a full board / expedited / exempt / non- regulated project naming Children’s Health as a performance site is received from any reviewing IRB, the designated Quality Specialist (QS) assigned to review full board studies / expedited studies / exempt studies / non-regulated projects will initiate the study in Integrify®.
6. PROCESS
A. When the research project is submitted to any reviewing Institutional Review Board (IRB) by a study team, a notification will be received in the Research Administration (RA) mailbox from the reviewing IRB and/or study team or Children’s RA Leadership.
B. INITIALIZATION FORM: Upon receipt of the study submitted notification that a study is seeking performance site review/approval at Children’s Health, the Quality Specialist (or designee) assigned to that category of review will log into Integrify® and complete the STUDY INITIALIZATION FORM. The INITIALIZATION FORM identifies the study’s Principal Investigator (PI), the Primary Research Coordinator (PRC), their contact information, the IRB name and study number associated with the study, and the study title.
C. INTAKEFORM:NexttheINTAKEFORMiscompleted.Onlythosespecificresearch services required for the study will be identified on this form. Depending on the project type and services required, the QS reviewer will only select the ancillary services that are appropriate to the study being reviewed. Research service partners or services needed include, but are not limited to:
a. Performance Site Review and Approval request
b. Adult Recruitment approval
c. Advanced Analytics data services
d. Biostatistician services
e. Children’s REDCap data storage
f. CMC Investigational Drug Services (IDS)
g. Credentialing / training requirements
h. Data Use Agreement
i. Facility Use Agreements (for industry-sponsored studies only)
j. Lab/Pathology services
k. Radiology/Imaging services
l. Other Ancillary services (Sleep study, Ophthalmology, etc.)
SOP No. 26, 07-14-2021; Update 07-28-21; Update 08-03-21; Final 08-11-21