Course Description______________________________
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 individual privacy protections. But both sets of rules can work well with one another, supporting protection for individuals on studies. This session presents common misunderstandings regarding the roles and responsibilities of clinical research sponsors, sites, and IRBs regarding HIPAA & clinical trials. The course also offers sponsors, sites, and IRBs application strategies for improved clinical trial conduct post HIPAA.
Learning Objectives______________________________
- Discuss many of the frequently misunderstood components of the Privacy Rule relating to clinical research source documentation disclosure
- Answer many of the questions regarding frequently misunderstood components of the Privacy Rule relating to clinical research
- Describe the latest guidance and notices relating to the Privacy Rule impacting clinical researc
Who Should Attend_______________________________
- Research Site Trainers
- Sponsor/CRO Trainers
- CRAs
- CRC
- Quality Assurance
- Other site study personnel working with study records
Instructor _______________________________________
Sandra “SAM” Sather, M.S., B.S.N., C.C.R.A., C.C.R.C.
Click here for complete trainer biographies
Course Length and Time___________________________
1.5 hours; 12:30 – 2:00 p.m. Eastern
Course Dates ____________________________________
June 2, 2010
Fee____________________________________________
$595
Includes up to 20 participants at one site. All participants (up to 20) are eligible for “Certificates of Attendance,” and accreditation, provided that accreditation requirements are met. For groups larger than 20 or for additional sites, call 1-800-856-2556 for pricing.
Accreditation___________________________________
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 1.5 hours (0.15 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test, and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE#: 778-000-09-068-L04-P. Released 3/10.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.