Research Coordinator Bulletin

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August 13th, 2015

Everything You Want to Know (…or Not) About HIPAA!

sign up hereThere’s still time!  Sign up for the 8/21 HIPAA education session.

Laura La Corte (Office of Compliance) will explain documentation of subject authorization, review of subjects’ medical records…and answer all your questions.

Detailslunchandlearn

  • When: Friday Aug 21st @ Noon – 1pm
  • Where: NRT LG 503/4 – Harlyne Tower
  • RSVP is required; lunch provided

Click here to RSVP

If you RSVP but are later unable to attend, please let us know (email research.coordinator@usc.edu).

August 3rd, 2015

Coordinator Update: August 2015

Greetings Coordinators! This edition includes the following updates:

If you have suggestions or questions, please email us at .

Hope to see you soon!

OPRS

 

August 3rd, 2015

Coming Soon: Education Sessions

calendarSummer Session

Fall Sessions

  • New CTSI Clinical Research Support Office
    Learn about the new Clinical Research Support Office and the services and resources available to researchers conducting Investigator-Initiated Trials.
  • Clinical Trials Billing (2 day event)
    The Clinical Trials Office and SPA will offer a 2 day workshop on pre- and post-award research billing.  Join us to learn billing basics and process updates.

Stay tuned for Fall Session details.

August 3rd, 2015

“HIPAA and Clinical Trials” Session

educationSign up for the next coordinator lunch to learn how the Privacy Rule impacts clinical research.

Discussion will include HIPAA waivers, “preparatory to research” activities, documentation of HIPAA authorization, subject confidentiality and more!

Speaker: Laura La Corte, JD (Office of Compliance)

Details

  • Friday August 21st @ Noon – 1pm
  • Location: Norris Topping Tower LG 503/4 – Harlyne Tower
  • RSVP is required; lunch provided

Click here to RSVP

If you RSVP but are later unable to attend, please let us know (email research.coordinator@usc.edu).

August 3rd, 2015

Is Your Data Coded, Identifiable, or Anonymous?

headscratchA common finding from OPRS not-for-cause audits is that IRB applications state that data is coded when, in fact, data is identifiable. If your subject files contain subject names, medical record numbers, date of birth, etc., data is identifiable. See definitions below.

Coded: labeled with a code that researchers can link to personal identifying information

Identifiable: directly labeled with personal identifying information such as name, date of birth, medical record #

Anonymous: not labeled with personal identifying information nor a code that researchers can link to personal identifying information


 

lightbulbTip: Double-check your IRB application (iStar question #26.2) to ensure it accurately reflects study practice. 

 

August 3rd, 2015

CTSI Job Openings

SC CTSI logoThe CTSI Clinical Research Support (CRS) group will support investigators in the conduct of clinical trials and translational research projects by providing assistance with study design, enrollment goals, study workflow, data analysis and reporting and regulatory requirements.

Currently, two positions are available:

Research Coordinator Supervisor
Research Navigator

For additional information, please contact CTSI Deputy Director Julie Statzel.

August 3rd, 2015

USC Clinical Research Resources Needed!

hear-from-youHelp us customize the USC-specific module for the CITI Coordinator Course.  Tell us if your department has:

  • specific clinical research resources such as forms, website, training
  • research services or procedures provided by your department such as tests, assessments
  • other valuable resources that can help USC researchers

We would love your help…all contributions are welcome! Email us at .

OPRS

 

August 3rd, 2015

Updates to the CITI GCP Course

The Good Clinical Practice (GCP) course has been updated:CITI

  • GCP courses are now available as two separate tracks:
    • Clinical Trials with Investigational Drugs and Biologics
    • Clinical Trials with Investigational Medical Devices
  • A refresher course is available for the Drugs and Biologics track; the refresher course for Medical Devices will be available within the next few months. Stay tuned.
  • The refresher course is accessible six months from completion of the Basic Course in case *early access to GCP training is necessary

*Note: Completion of the GCP course is required for Principal Investigators and research staff conducting expedited and full board clinical trials. The course is only required once even though the certificate includes an expiration date.

May 8th, 2015

Coordinator Update: May 2015

newsandeventsGreetings Coordinators! This edition includes the following updates:

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

May 8th, 2015

Last Call: LAC+USC Agreement Session

rsvp2Don’t forget to sign-up for the coordinator lunch focused on the LAC+USC Agreement.  Speakers include:

  • Dr. Tom Buchanan: Overview and Implications of New Agreement
  • Dr. Darcy Spicer: Operational “Nuts and Bolts”
  • Phillip Moore: Effect, Impact and Difference on County Research Process

Details

  • Friday May 15th @ Noon – 1:30pm
  • Location: Hastings Auditorium (HMR 100)

Click here to RSVP

If you RSVP but are unable to attend, please email us.