Research Coordinator Bulletin

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December 11th, 2014

Season’s Greetings Coordinators!

happy holidayBefore heading out for the Winter Recess, check out the following updates:

Happy Holidays,

OPRS

December 11th, 2014

Next RC session: SPAs and Hospital Billing

billingBased on your votes, the next education topic will feature representatives from Sponsored Projects Accounting (SPA) and Hospital Billing.

If you’d like to participate in our panel, please let us know at research.coordinator@usc.edu.

Stay tuned for event date (tentatively late January) and location details.

December 11th, 2014

Important Update: SOCRA Reimbursement

If you did not previously register for the SOCRA opportunity because you thought you were ineligible, note the following:

Note: applicants must register with SOCRA by 12/26/14.

December 11th, 2014

IRB Policies Updated (Dec 2014)

pnpsThe 2014 Human Subjects Protection Policies (HSPP) are now available.  Updates reflect new regulations, best practices and format changes.  Click here for a quick overview of policy changes.

To ensure access to the latest version of the Policies, always check the HSPP webpage.

December 11th, 2014

Office of Research Service Commitment

service commitmentCheck out the Service Commitment from units under the Office of Research umbrella, including:

  • Office of Research Central Office
  • Animal Resources/IACUC
  • Contracts and Grants/Clinical Trials Office
  • DC Research Advancement
  • Office for the Protection of Research Subjects/IRB
  • USC Stevens Center for Innovation
November 17th, 2014

Coordinator Update – November 2014

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Greetings coordinators!  This edition includes the following updates:

If you have suggestions or questions, please email us at research.coordinator@usc.edu.

 

 

November 17th, 2014

October Education Session…a Success!

we did itLast month’s “Setting Up a Clinical Trial at USC” session was a hit!  The lively discussion was a result of engaged coordinators and great turnout.  Thank you to all those who attended.  See meeting highlights in next article.

If we keep these numbers up, we’ll continue these events.  However, we rely on you for topic ideas.  Cast your vote for the next event below.

November 17th, 2014

Highlights from October Lunch

Presenters were Dr. Randy Hall (Office of Research) and Soheil Jadali (Clinical Trials Office).

Items coordinators requested follow-up on were:

  • adequate coverage for IDS Pharmacy
  • study amendments that do not involve budget changes
  • clarification between SPAs.

Below are notable highlights from the education session.


IDS Pharmacy

  • IDS Pharmacy hours are 8am to 4pmmortar_pestle; no after hours coverage is available
  • Coordinators are unable to obtain investigational drugs for study subjects outside regular hours of operation; arrangements can be made with Keck Hospital pharmacy but this causes delays for studies conducted outside of Keck
  • Limited hours of operation are an impediment to research, results in low enrollment, inability to conduct certain studies and protocol deviations
  • Dr. Hall will look into this situation

Study Amendments: IRB, CTO and budget implications

  • Coordinators report that amendments that do not involve budget changes cause unnecessary delays in IRB and CTO approval and question if CTO review is necessary when a procedure is not billable to the sponsor.  Soheil clarified that amendments involving new procedures that are not billable to the sponsor may still require CTO to update the Medicare Coverage Analysis.
  • contractAdditionally, the process to bill research staff time for amendments (e.g., IRB submission, coordinator time) was unclear.  Per Soheil, these costs should be built-in to the contract agreement with the sponsor at the beginning of the study and coordinators can follow-up with SPA to request these payments from the sponsor.
  • Coordinators requested additional guidance for post-award billing, including clarification between roles of Clinical Trials Sponsored Projects Accounting (SPA) and “general” SPA.

OnCore Clinical Trials Management System (CTMS) QuestionsOnCore

  • OnCore CTMS will be used for clinical trial management at USC and CHLA; working group sessions are currently underway
  • Visit the Office of Research webpage for information about OnCore
  • For CTMS questions, contact Dr. Joshua Lee (Chief Information Officer)

Remember ClinCard Set-Up at Study Start-Up

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  • Subject reimbursement must be built-in to the study budget/award at the beginning of the study to avoid problems setting up a ClinCard account.
  • Remember to include subject reimbursement in study budgets, especially for non-industry studies, as budget details are handled at the department level.
November 17th, 2014

Message from Dr. Randolph Hall

Research Coordinators,message

Here is the complete presentation from the October RC lunch entitled “Clinical Research Update and CTO Processes”.  Thanks to those of you who could attend.

Randolph Hall

Vice President, Research

November 17th, 2014

New NIH Definition of “Clinical Trial”

nihUSC has adopted the NIH revised definition of “clinical trial”.  The new definition makes clearer the difference between clinical trials and clinical research studies and includes socio-behavioral clinical trials.  No changes have been made to the NIH definition of a “Phase III clinical trial.”

The definition is effective for competing NIH grant applications and contracts proposals on January 25, 2015.

Read the NIH Notice