Event Calendar
Chapter Chairperson:

Laura Holtz, BS, CCRP
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Indianapolis

SOCRA Indianopolis Chapter Meeting

You are invited to attend an educational workshop hosted by the SOCRA - Indianapolis Chapter!

 

DATE               Saturday, February 23, 2019

LOCATION       Regenstrief Institute Social Hub
                          1101 W 10th Street, Indianapolis, IN 46202  

Visitor parking spaces are available on the south side of the building as well as in an IUPUI EM parking lot. If spaces are full, the Wilson Street parking garage is across the street from the building for a nominal charge. 

AGENDA

8:30 - 8:45 AM                  Welcome & Announcements

8:45 - 10:00 AM              Session 1: Evaluating the Design of Clinical Trial Eligibility Criteria -
                                                               Are Exclusion Criteria Overly Restrictive?
(1.25 CE)

Abby Staler, PhD, MPH, MA, CCRP (Research Associate, Cleveland Clinic Taussig Cancer Institute)

  1. Describe the consistency of eligibility criteria (hematologic malignancies) with expected toxicities and observed adverse events.
  2. Define reasons leukemia patients are ineligible for SWOG clinical trials and understand how ineligible patients inadvertently enrolled onto clinical trials perform relative to eligible patients.
  3. Discuss the potential health policy implications of overly restrictive eligibility criteria.

10:00 - 11:00 AM     Session 2: Research Subject Recruitment: Beyond the Healthcare Setting (1 CE)

Amy Trullinger (Single IRB Project Manager, Indiana CTSI, Indiana University School of Medicine)

  1. Identify challenges to subject recruitment
  2. Explore recruitment opportunities for research beyond the healthcare setting
  3. Discuss how recruitment fits into an IRB submission

11:00 - 12:15 PM              Session 3: Beyond Informed Consent Regulations: Seeking Consent
                                                                in the REAL World
(1.25 CE)

Laura R. Holtz, MS, CCRP (Senior Research Manager, Regenstrief Institute, IU Center for Aging Research)

  1. Understand 21 CFR 50, General requirements for Informed Consent for human subjects research.
  2. Recognize vulnerable populations for research to utilize the appropriate mechanisms for obtaining informed consent that employs protections for research subjects.
  3. Discuss strategies and processes to seek and obtain informed consent from potential research subjects including those with cognitive impairment.      

 

12:15 - 12:30 PM           SOCRA Opportunities Q&A (national conferences, annual conference poster presentation, etc.)

Please share this invitation with your colleagues. All SOCRA members and nonmembers are welcome to attend this workshop at no charge. Certificates of attendance will be granted for up to 3.5 CEU for SOCRA members only.

The Society of Clinical Research Associates (SOCRA) is a non-profit, charitable and educational membership organization committed to providing education, certification, and networking opportunities to all persons involved in clinical research activities.

For more information, please contact Lyndsi Moser (Co-Chairperson) at lrhabegg@iupui.edu.

To RSVP, please go to: https://www.eventbrite.com/e/socra-indianapolis-chapter-february-2019-workshop-tickets-55428768940

You do not need to print out the EventBrite ticket.

Please share this announcement with your colleagues