Research Coordinator Bulletin

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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



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


  • 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


November 17th, 2014

From HSIRB: Informed Consent Guide

get help hereThe Health Sciences IRB has released a Guide for Informed Consent Authors and Editors which provides guidance for creating new consent forms or revising approved consent forms.  If you submit HSIRB consent forms that do not comply with these instructions, your submission may be returned without review.

October 15th, 2014

Don’t forget to RSVP for next RC Event!


Topic: Setting Up a Clinical Trial at USC

Speakers: Dr. Randolph Hall & Soheil Jadali

Date: Wednesday October 29 | Noon to 1:30pm

Location: Norris Topping Tower 7409

Lunch will be provided.  To RSVP, click here
Note: continuation of coordinator events depends on attendance and interest. 
If this event is well-attended, our next event will focus on the new USC Clinical Trial Management System (CTMS).
September 26th, 2014

OPRS Fall Greetings – September 2014

fall-seasonImportant developments are underway this year for USC coordinators and researchers, including:

Stay tuned for details.  We look forward to seeing you soon!


September 26th, 2014

Setting Up a Clinical Trial at USC

Education Session

educationJoin us next month to learn the ins-and-outs of setting up a clinical trial at USC, including the role of the Clinical Trials Office, how type of funding affects the process, and the various electronic systems involved.  Featured speakers include:

  • Soheil Jadali – Clinical Trials Office Director
  • Randolph Hall, PhD – Vice President of Research

Event Details

  • Wednesday Oct 29th @ Noon – 1:30pm
  • Norris Topping Tower 7409
  • Lunch will be provided; RSVP is required.

Click here to RSVP

If you RSVP but are later unable to attend, please let us know (email


September 26th, 2014

SOCRA Certification Event

socraThe Office of Research is sponsoring a SOCRA Coordinator Certification Preparation and Exam event this Spring (see below).

Take advantage of this great opportunity.  Become a Certified Research Coordinator!

Prep Course: Feb 5, 2015 @ 8am-4pm

Exam:  Feb 6, 2015 @ 8am-12pm

Location: Aresty Auditorium (HSC)

For detailed information, see this announcement.

Note: to maximize your reimbursement, register early.