USC Clinical Trials Office (CTO) Submitting your Studies to CTO For Processing Soheil Jadali Director, Clinical Trial Office

Clinical Trials Office (CTO) CTO is responsible for pre-award portion of administrative management of clinical trials at USC. Transition from Pre-award to Post-award – Billing and Accounting Services Coordinating efforts with other units and departments involved in clinical trial management, including hospital billing and compliance office Study Activation Coverage Analysis Contract Review, Negotiation, and Execution Budget Development and Negotiation

Clinical Trial Initiation In True 2.0 If you have any problems with your True 2.0 access, or need to get a True 2.0 login account, please contact: Nancy Yi, Senior Programmer Phone: (323) PI/Research Coordinator completes smart forms in True 2.0 and submits it to CTO. Based on responses provided, various groups participating in the study will receive automatic notifications (e.g. CTU, Pathology, pharmacy services). CTO will review the submission looking for all mandatory documents – i.e. study protocol, Clinical Trial Agreement, proposed sponsor budget, and informed consent form.

Clinical Trial Initiation In True 2.0 Cont.…

Clinical Trial Initiation In True 2.0 Cont.…. These are your choices, If you are submitting a Sponsor-Initiated study that will be funded by the sponsor.

Clinical Trial Initiation In True 2.0 Cont.…. This is your choice, If you are seeking funding for a PI-initiated study or a Sponsor-Initiated study for which sponsor is not providing the study costs.

Clinical Trial Initiation In True 2.0 Cont.….

This form provides essential information that is needed for CTO processes.

Clinical Trial Initiation In True 2.0 Cont.…. If this is a Device Study….

Clinical Trial Initiation In True 2.0 Cont.….

If you are working with a CRO, this is where you would provide their information:

Clinical Trial Initiation In True 2.0 Cont.….

Primary Contact: Please make sure your Primary Contact is available to any questions or clarification requests related to this study in a timely fashion.

Clinical Trial Initiation In True 2.0 Cont.….

This form is an important part of your submission, because it provides information needed to make sure all costs associated with this study (e.g. CTU, lab services, etc…) are covered In our final study budget. Also, there are automated notifications that will go out at a result of your selections on this page.

Clinical Trial Initiation In True 2.0 Cont.…. Depending on specifics related to the protocol and the study there may be some additional documents needed for CTO processing. These include lab manual, imaging manual, and additional documents that are referenced in the study protocol.

Clinical Trial Initiation In True 2.0 Cont.…. You are not done submitting yet…..

Clinical Trial Initiation In True 2.0 Cont.….

It is very important for your to monitor your True 2.0 “My Inbox” page within the hours from your submission. If/when there are issues with your submission, CTO will send back your submission to “Returned to Presubmission” status in order for you to make the required adjustments. You will receive a notification about this as well.

Clinical Trial Initiation In True 2.0 Cont.….

TRUE 2.0 Notification Subject: Trial Submission accepted by HRA To: Rebecca Simms From: Soheil Jadali Regarding: FP Test_SC9678 Status: Awaiting Contract and Budget Description: Your study submission has been accepted by HRA on 2/7/2014 1:25 PM. If additional documents are needed, you will be notified. Once CTO accepts your submission, you will receive an notification such as the example below.

CTO’s Processes and Study Activation CTO Processes Contract Terms are Negotiated. CA & Budget are completed. Compliance Approvals IRB and other compliance approvals are in place. CTO conducts IRB Consistency Checklist Study Activation Contract Manager will route the CTA for final signatures. Fully executed CTA including the final budget + Final CA + IRB consistency checklist + IRB approval = Study activation

Transition from Pre-award to Post-award  Final executed CTA is sent to Kuali Coeus (KC) entry.  Final Agreement and budget information is entered in IRIS.  Final documents are sent for TRUE: Trial Registration Update Entry – is a database maintained by SPA/Clinical Trials, which contains, study participant information, study calendar, research order form and Medicare coverage for clinical trials.

Special Topics FDA 21 CFR - Part 11 Compliance  This refers to FDA requirement to have technological & procedural controls to protect study data.  Please contact your CTO Contract Manager contact, if you receive a Part 11 compliance request from sponsors. Hospital VAC Form – Value Analysis Committee  It is required for Device Studies.  Research Coordinators are responsible for submitting the VAC form for review and approval.  CTO requires the approved VAC form in order to confirm hospital’s approval for MCA/billing purposes. Study Data Storage & Associated Costs  Budgets should include the cost of study data storage and record retention.  This is especially important, when sponsors ‘ data storage and record retention is longer than FDA mandated periods (i.e. two years after FDA approval or study abandonment).  Please work with your designated Budget Specialist at CTO to include these costs in studies final budgets.

Questions?

CTO Resources For more information please contact CTO at: or Please visit our Website at: