Page 62 - eBook Version 8 Book 1 of 2 JUL 2022

STANDARD OPERATING PROCEDURE Research Administration SOP No: R-Reg-004 SOP Title: Study Initiation with Pharmacy
will ensure adherence to this SOP. In some case, a UTSW regulatory team lead may complete the IDS initiation. The CRC/A should confirm with their team lead about who will assume the responsibility of the SEV. The team lead will ensure the appropriate institution is credited the start-up time on the transition sheet of the CTS (see SOP Securing Reimbursement for Research Study). The remainder of this SOP outlines the steps to be taken in the event that a CHST team member will complete the IDS initiation.
4. RESPONSIBILITIES
All investigational drugs are stored and dispensed by the IDS pharmacy located in the Main Hospital – DL400. The IDS pharmacy keeps temperature and drug accountability logs on all investigational drugs stored in the pharmacy. This information may be requested by the sponsor to provide assurance of drug viability throughout the study. It is important that information about the delegation of IP management be written and filed in the appropriate section of the regulatory binder. All CVs, licenses, training and certifications should be maintained in the clinical research essential resource binder (CRER) (see SOP clinical research essential resource binder). The department’s note to file (NTF) regarding maintenance of essentials documents can be found attached at the end of this document. When utilizing the CRER binder, please follow the following steps: Access the RA shared drive and go to 2020 RESESARCH CREDENTIALS to locate the CRER electronic binders. An “Archives” folder will be in each research staff’s folder to store expired documents:
T:\CCS_RESEARCH\2020 RESESARCH CREDENTIALS
Investigational Drug Service (IDS)
The IDS will assume responsibility for the following:
• Receipt of Investigational Product (IP)
• IP Storage
• IP accountability – uses VESTIGO electronic accountability system unless another system has been discussed and approved by IDS and Sponsor
• Randomization, when applicable
• Blinding and maintaining the blind, when applicable
• Temperature Logs
5. SPECIFIC PROCEDURE
5.1 Notification of New Study
Once CHST has been approved as a site for a research study, inform IDS of the study as soon as possible, in order to have IDS determine the cost and resources needed for pharmacy services.
• Email the IDSRx the following items (IDSRx@childrens.com) o Protocol
o InvestigatorBrochure
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