1. Investigator Meeting Meeting The EFIC Regulations EOS PD- The ProTECTIII Trial September, 2014 Deneil Harney MPH, MSW Human Subjects Protection Coordinator University of Michigan

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

3. EOS PD Resources Protectiii.com Investigator tools > Study Closeout

4. EOS PD Resources EFIC tasks

5. EOS PD Resources EFIC tasks cont.

6. EOS PD Activities Conducted for RAMPART EOS PD METHOD% used% reached Examples Online post26%44% Online releases: local radio, tv and newspaper, institution newpaper, YouTube, and other online media sites, e.g., news-medical.net, Sci Guru, Newsedge, BrainTalk Communities, etc. Presentation14%< 1% Grand rounds, community groups, conferences, etc. Email circular12%1% Internal employee & department email groups Newspaper10%44% Local newspapers Mailing10%< 1% Local community groups reached during CC Material distribution7%< 1% E.d waiting rm., outpatient neurology clinic, national conferences, religious organizations Radio announcement5%4% PSA Website article4%<1% NETT, institution & department websites Letter to subjects4%n/a Newsletter3%4% Local epilepsy, TBI, chapter newsletter T.V.2% Local news station Press release2%6% To media outlets Social media1%none given Twitter & fb Billboard<1 %none given Public transit Totaln = 2775,734,475

7. 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 o After the manuscript is published A press release will be made available late fall/winter o 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?