1 / 14

Investigator Meeting Meeting The EFIC Regulations EOS PD- The ProTECTIII Trial September, 2014

Investigator Meeting Meeting The EFIC Regulations EOS PD- The ProTECTIII Trial September, 2014 Deneil Harney MPH, MSW Human Subjects Protection Coordinator University of Michigan. Outline. EOS Public Disclosure R esources – ProTECT website Milestone document 2 of 2

jenas
Download Presentation

Investigator Meeting Meeting The EFIC Regulations EOS PD- The ProTECTIII Trial September, 2014

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Investigator Meeting Meeting The EFIC Regulations EOS PD- The ProTECTIII Trial September, 2014 Deneil Harney MPH, MSWHuman Subjects Protection CoordinatorUniversity of Michigan

  2. Outline • EOS Public Disclosure • Resources – • ProTECT website • Milestone document 2 of 2 • EOS PD activities conducted for RAMPART • Capturing EOS PD events in WebDCU • To the FDA • Talking to the media

  3. EOS PD ResourcesProtectiii.comInvestigator tools > Study Closeout

  4. EOS PD ResourcesEFIC tasks

  5. EOS PD ResourcesEFIC tasks cont.

  6. EOS PD Activities Conducted for RAMPART

  7. Capturing EOS PD events in WebDCU

  8. Capturing EOS PD events in WebDCU

  9. To the FDA Docket!www.regulations.gov/#!docketDetail;D=FDA-1995-S-0036

  10. Press - How to Contact your PR Office now • Learn who your PR person is • Let them know the study results are forthcoming (late fall/early winter) Media resources available at protectiii.com • If a reporter contacts you • Guidelines for support staff • Tips for working with the news media • preparing, during and after the interview • tips for radio and tv interviews

  11. Press: How cont. • Don’t take a direct call from a reporter • Don’t call back a reporter without your PR person’s help in setting up a meeting • Don’t ignore a reporters calls or messages , or delay responding – this only makes them angry Bottom line: If a reporter calls, e-mails, or shows up unannounced, call your PR person. Together, you can decide what to do.

  12. Press: When & Message • After the manuscript is published • A press release will be made available late fall/winter • In the interim • Keep it short • Stay on message (reference messages already available) • Study stop – subject notification letter • ProTECTiii.com • Existing EFIC material Share: “We are working through the academic process and I can’t go any further until the publication is out.”

  13. Press: ProTECT ProTECT specific • Notify Dr. Wright when: • you have given a statement to a reporter • you become aware of any bad press published about ProTECT

  14. Questions?

More Related