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ForwardRetrospective Data Collection Studies: How to Avoid Compliance Issues
This course provides targeted instruction on the regulatory and procedural requirements for conducting retrospective data collection studies. Learners will gain clarity on IRB approval parameters, HIPAA privacy mandates under a waiver, and the necessity of accounting for disclosures of PHI. By the end of the course, researchers will be equipped to conduct retrospective studies in full compliance with institutional, IRB, and HIPAA standards, enhancing research integrity and minimizing risk.
Target Audience
Medical staff, residents and volunteers involved in human subject research at Baptist Health, working on a retrospective data collection study.
Learning Objectives
- Identify the approval parameters required for conducting a retrospective data collection study.
- Explain the importance of adhering to the IRB-approved protocol throughout the research process.
- Describe the privacy requirements associated with a waiver of HIPAA authorization.
- Summarize the procedural and documentation requirements for accounting for the disclosure of Protected Health Information (PHI) under a waiver of HIPAA Authorization.
Faculty
Conference Director:
Scott J Lipkin, DPM
Vice President for Research | Baptist Health South Florida
Chief Research Officer | Miami Cancer Institute
Author:
Amanda Coltes-Rojas, MPH, CIP, CHRC
Director, Research Integrity
Center for Research
Corporate Office for Research Integrity
Baptist Health South Florida
Amanda Coltes Rojas, MPH, author of this educational activity, has no relevant financial relationships with ineligible companies* to disclose, and has indicated that the presentation or discussion will not include off-label or unapproved product usage.
Scott Lipkin, DPM, conference director of this educational activity, has no relevant financial relationships with ineligible companies* to disclose, and has indicated that the presentation or discussion will not include off-label or unapproved product usage.
Non-faculty contributors and others involved in the planning, development, and editing/review of the content have no relevant financial relationships with ineligible companies* to disclose.
*Ineligible companies - Companies whose primary business is producing, marketing, selling, re-selling, or distributing healthcare products used by or on patients.
Baptist Health South Florida is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. Baptist Health has been re-surveyed by the ACCME and awarded Commendation for 6 years as a provider of CME for physicians.
Baptist Health South Florida designates this enduring material for a maximum of 0.50 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Available Credit
- 0.50 AMA PRA Category 1 Credit™
- 0.50 General certificate of attendance
Required Hardware/Software
PC/Mac Users
This site is supported on the most recent stable releases of the following browsers:
Google Chrome
Microsoft Edge
Safari
Mozilla Firefox
Mobile Users
This site is supported on the following mobile devices:
- Apple iOS mobile devices running iOS 10 or later
- Android mobile devices running Android 4.4 or later, with the latest release of Google Chrome or Mozilla Firefox
Technical Support
If you are experiencing technical difficulties or have received an error message, please send an email to [email protected] and include a print screen of the error message, your browser name and version, username and URL where the error occurred. You can expect a response within 48 hours.