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SCORE Study Coordinators’ Organization for Research & Education Wednesday, September 20, 2017 1 3 rd Wednesday of the Month 1-hour meetings + 30 minutes for networking For questions and to subscribe to listserv contact: [email protected]

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Page 1: Click to add title - urmc.rochester.edu GCP E6 R2 –Changes? Yes ... 9. What I liked best: ... Feedback –May 2017 Meeting HIPAA Compliant Electronic Communication with Human Subjects

SCOREStudy Coordinators’ Organization for Research & Education

Wednesday, September 20, 2017

1

3rd Wednesday of the Month

1-hour meetings +

30 minutes for networking

For questions and to subscribe to listserv contact: [email protected]

Page 2: Click to add title - urmc.rochester.edu GCP E6 R2 –Changes? Yes ... 9. What I liked best: ... Feedback –May 2017 Meeting HIPAA Compliant Electronic Communication with Human Subjects

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You are juggling so many things!

SCORE is here to help.

Page 3: Click to add title - urmc.rochester.edu GCP E6 R2 –Changes? Yes ... 9. What I liked best: ... Feedback –May 2017 Meeting HIPAA Compliant Electronic Communication with Human Subjects

OHSP Seminars

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Wed., September 27th, 12:00-1:00 pm; 1W-304

The Times They Are A-Changin’: An Overview of the Final Common

Rule Revisions

Emily Flagg, Sr. Regulatory Specialist, RSRB.

Wed., October 25th, 12:00-1:00 pm; 1W-304

ICH GCP E6 R2 – Changes? Yes. Challenges? Not as Difficult as You

May Fear

Lorrie D. Divers, President, QRCP Solutions, Inc.

Visit the OHSP website

Page 4: Click to add title - urmc.rochester.edu GCP E6 R2 –Changes? Yes ... 9. What I liked best: ... Feedback –May 2017 Meeting HIPAA Compliant Electronic Communication with Human Subjects

Training Opportunities for New Coordinators

• Orientation to Conducting Human Subject Research

• Research Boot Camp

• Core Training

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Visit the OHSP website

Self-enroll in the OHSP training through MyPath

Page 5: Click to add title - urmc.rochester.edu GCP E6 R2 –Changes? Yes ... 9. What I liked best: ... Feedback –May 2017 Meeting HIPAA Compliant Electronic Communication with Human Subjects

• The program is approved for 5 CEUs for SoCRA members

• Certificates of Attendance for non-SoCRA attendees will be provided

• For details, contact SCORE

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NYS SoCRA Chapter

Fall Program

Friday, November 3, 2017

8:00 am – 3:00 pm

Skaneateles Falls, NY

Page 6: Click to add title - urmc.rochester.edu GCP E6 R2 –Changes? Yes ... 9. What I liked best: ... Feedback –May 2017 Meeting HIPAA Compliant Electronic Communication with Human Subjects

First Clinical Research – this online resource provides information

on clinical research best practices to support sponsors, sites and other

agencies operate more effectively and efficiently and contains:

• Journal of Clinical Research Best Practices over 1,200 online

articles

• Searchable database over 600 laws, regulations and guidelines

• Searchable database over 7,000 FDA GCP Q&As

Today’s Resource Tip:

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Page 7: Click to add title - urmc.rochester.edu GCP E6 R2 –Changes? Yes ... 9. What I liked best: ... Feedback –May 2017 Meeting HIPAA Compliant Electronic Communication with Human Subjects

The CTSI Weekly Update and

Calendar are the sources for:

•Events

•Collaboration Opportunities

•Career Development Opportunities

•Funding Opportunities in Clinical

and Translational Science

Look for the newsletter

every Monday.

Do you have an item you would like to publicize in the

CTSI Weekly Update or Calendar?

Contact Katie Crane: [email protected].

CTSI Weekly Update

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Events from Sep 19th

Page 8: Click to add title - urmc.rochester.edu GCP E6 R2 –Changes? Yes ... 9. What I liked best: ... Feedback –May 2017 Meeting HIPAA Compliant Electronic Communication with Human Subjects

• Located on the CTSI “Connections” web page: https://www.urmc.rochester.edu/clinical-

translational-science-institute.aspx

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• Linked on the OHSP home web page

Additional Resources U of R

websites Study Coordinators

Organization for Research &

Education

SCORE Website

Page 9: Click to add title - urmc.rochester.edu GCP E6 R2 –Changes? Yes ... 9. What I liked best: ... Feedback –May 2017 Meeting HIPAA Compliant Electronic Communication with Human Subjects

UR Coordinator Discussion Listserv Titled:

CTSI SCORE Chat

This online forum provides opportunities

to chat with peer coordinators and

to share resources and practices.

To subscribe, email SCORE.

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Page 10: Click to add title - urmc.rochester.edu GCP E6 R2 –Changes? Yes ... 9. What I liked best: ... Feedback –May 2017 Meeting HIPAA Compliant Electronic Communication with Human Subjects

What I liked best:

“Having specific examples to discuss whether email consent was needed was very helpful.”

“Case scenarios were good for discussions; he kept it light-hearted.”

“Excellent presenter, very engaging.”

Feedback – May 2017 Meeting

HIPAA Compliant Electronic Communication

with Human Subjects in Research

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Page 11: Click to add title - urmc.rochester.edu GCP E6 R2 –Changes? Yes ... 9. What I liked best: ... Feedback –May 2017 Meeting HIPAA Compliant Electronic Communication with Human Subjects

Peer Institutions•UNYTE•CTSAs

Government AgenciesContract Research OrganizationsOthers Identified to meet needs

Trial Innovation CentersRecruitment Innovation Center

Research Help Desk

Center for Community HealthCenter for Human Experimental

TherapeuticsClinical Research Center

Center for Research Implementation and TranslationBiomedical Informatics

ClinicalTrials.gov RegistrationEducation and TrainingeRecord for Research

FDA Regulatory ComplianceMentoring

Research EthicsResearch Methods ForumPilot and Incubator Funding

BiostatisticsComparative Effectiveness

EpidemiologyHuman Behavior AssessmentPhysical Exercise Activity

Kinesiology (PEAK) LabURMC Labs

Shared Resource LaboratoriesScientific Writing Services

Research Services and Resources

Support Provided

Through the CTSI:

CTSI-Associated

Centers:

Affiliated

UR Resources:

External

Resources:

[email protected]

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New HIPAA Privacy Officer for Research

Kathleen [email protected]

585-784-6154

Page 13: Click to add title - urmc.rochester.edu GCP E6 R2 –Changes? Yes ... 9. What I liked best: ... Feedback –May 2017 Meeting HIPAA Compliant Electronic Communication with Human Subjects

ResearchMatch.org –

Creating Effective Subject Contact MessagesPresented by:

Nancy A. Needler BS CCRC

CTSI, Manager, Research Coordinator Program

ePARC/Epic –

Changes Affecting Research Coordinators

Facilitated by:

Mike Ritz, ORPA, Research Compliance Officer

Presentation materials will be available on the SCORE website

Today’s Open Discussion

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