Events
A Virtual Chapter Meeting with Online Webinar
Meeting HIPAA & FDA Requirements for Case Histories
| Date: |
July 27, 2010 |
| Time: |
7:00- 9:00pm
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| Location: |
Your PC – it's VIRTUAL
|
| Questions: |
Chapter Contact Person: Jeff Berg
Contact Person’s Email: jberg1@tampabay.rr.com
Contact Person’s Phone: (727) 344-7602 ext. 288 |
| Cost: |
Member: $0 for attendance ($10 for 2.5 CEUs); Non-Member: NA must be member
|
| Contact Hours: |
PURCHASE CONTACT HOURS
Registrations are accepted through August 3rd.
|
| Speaker: |
Sandra "SAM" Sather, MS, BSN, CCRC, CCRA - SAM has over 25 years of clinical training and research experience.
She is the vice-president of Clinical Pathways, a consulting team out of North Carolina that provides training, monitoring,
auditing and other services for clients in the clinical research drug and device industry. SAM is dual certified by ACRP and is
the chair for CCRA Exam Committee. She has a BSN and her Master’s of Science in Education with a specialization in Human Performance Improvement. SAM is a frequent speaker at industry events and has authored over 50 courses for clinical
research training programs. |
| Program Description: |
We will be using "GoToMeeting" technology. Members will be shown how to participate and contribute to future chapter events using new eTools. As part of the chapter meeting, "SAM" will present in a webinar format our program as follows, the HIPAA Privacy Rule has been in effect for some time, but still the FDA clinical investigator’s and Privacy Rule covered entities requirements in many cases are not easily harmonized, supporting adequate original source documentation and monitoring (no matter the media, i.e. paper or electronic) and individual subject’s privacy protections. This session presents solutions to common misunderstandings regarding the roles and responsibilities of clinical research sponsors, sites, and IRBs regarding HIPAA & clinical trials source documentation. |
| Objectives: |
- Participants will learn how to access Chapter eForum, download the required session hand-outs and evaluation form.
- Participants will gain an understanding of how to become more involved in local chapter activities using eToolsReview the required characteristics for source documents in any form (i.e. paper or electronic).
- Apply the source document characteristics to electronic medical records at research sites.
- Discuss frequently misunderstood components of the Privacy Rule relating to source documentation disclosure.
- Contingency planning for electronic source document verification that meets both HIPAA and FDA requirements.
|
| Agenda: |
Prior to event: Access Chapter eForum to download hand-outs (15 min)
7:00pm-7:30 Virtual chapter meeting (30 min)
7:30-8:30 Webinar- Sam Sather (60 min)
8:30-8:45 Follow-up questions (15 min)
8:45-9:00pm Explanation of evaluation process/online tools
After event: Submit comments based on webinar which will be used to write a summary paper (15 min) |
| Target Audience: |
CRCs, CRAs, Site Managers, Sponsor/CRO Trainers , Research Site Trainers, QA personnel |
Contacts
Chapter Email Address
suncoastchapterACRP@gmail.com
President
Jeffrey Berg, B.Sc., CCRA
Tel. (813) 885-5137
Fax (727) 345-5323
jberg1@tampabay.rr.com
Vice-President
Yvonne Gorham, CIM
Tel. (727) 467-9393 x.209
Fax: (727) 443-2385
yvonne@ccicheart.com
Secretary
Charlene McCarthy, MPH, CCRC
Tel. (727) 398-6661 x.7630
Fax: (727) 398-9554
wilma.mccarthy@va.gov
Treasurer
Frank Persechino, RN, BSN
Tel: (727) 631-0779
Fax: (727) 461-5664
frank@researchalliance.net
Members at Large
Diane Martinez, CIM, CRCP
Tel. (727) 244-2219
dianemartinez@earthlink.net
Jane Marie Johnson, CCRA
wjohns3@tampabay.rr.com
Committee Volunteers
Conne Parks
Marla Davis
Kathy Bauer
Jane Marie Johnson