USC Clinical Trials Office (CTO) Submitting your Studies to CTO For Processing Soheil Jadali...

USC Clinical Trials Office (CTO)

Submitting your Studies to CTO For Processing

Soheil JadaliDirector, 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 ProgrammerPhone: (323)865-7784Email: nancy.yi@med.usc.edu

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.

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.

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

If this is a Device Study….

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

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.

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.

You are not done submitting yet…..

It is very important for your to monitor your True 2.0 “My Inbox” page within the 24-48 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 email about this as well.

TRUE 2.0 Notification

Subject: Trial Submission accepted by HRA

To: Rebecca SimmsFrom: Soheil JadaliRegarding: FP00000853 - Test_SC9678Status: Awaiting Contract and BudgetDescription: 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 email notification such as theexample 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:

323-442-7218 or kalbarcz@usc.edu

Please visit our Website at: https://research.usc.edu/clinical-trials-at-usc/

USC Clinical Trials Office (CTO) Submitting your Studies to CTO For Processing Soheil Jadali...

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