Neurological Emergencies Treatment Trials Network

1. Neurological Emergencies Treatment Trials Network RAMPART This award is funded with support of NINDS, BARDA and the NIH CounterACT program.

2. Project Roster • This is where you can communicate to the CCC about your Study Team • Please visit the Project Roster to • Update incorrect information • Add new study team personnel • Remove study team personnel no longer participating • Study team members need to be included for their roles on each project, at each spoke. • Example: John Doe, Co-I, RAMPART, Site 1 • Example: John Doe, Co-I, RAMPART, Site 4 • REMINDER: Each study team member needs to be accounted for in the Project Roster to be included in WebDCU.

3. WebDCUTM • Each Hub is responsible for: • Ensuring all required documentation is current in WebDCU • Checking WebDCU regularly for expired and rejected documents • This includes regulatory documents for ALL • Spokes • EMS Entities • Team Members

4. Required Regulatory Documents • People Level Documents • Curriculum Vitae • HIPAA Certification • Human Subjects Protection Certification • Medical License • RAMPART Protocol Training • RAMPART Data Training • RAMPART 1572

5. Required Regulatory Documents • Spoke Level Documents • RAMPART EFIC CC & PD Plan • RAMPART CC Schedule • RAMPART PD Schedule • IRB Federalwide Assurance • RAMPART Protocol v2 IRB Approval • RAMPART IRB Approved Informed Consent Form v1d • RAMPART IRB Approved Patient Notification Forms • RAMPART Delegation of Authority Log

6. Required Regulatory Documents • EMS Level Documents • RAMPART EFIC CC & PD Plan • RAMPART CC Schedule • RAMPART PD Schedule • IRB Federalwide Assurance • RAMPART Protocol v2 IRB Approval • RAMPART Regulatory Requirements Schedule • RAMPART EMS Education Schedule • RAMPART EMS Training Log • RAMPART EMS Department Study Approval Letter • RAMPART EMS Pharmacy Control Plan

7. People Level Documents • Regulatory Documents valid across Studies • Curriculum Vitae • Required for all site personnel listed on the 1572, Study Coordinators, EMS Coordinators, and any other personnel directly involved in the study • CVs must be signed and dated • Valid for 1 year for PIs • Valid for 2 years for all other study team members • HIPAA and Human Subjects Protection Certification • Certification required for Investigators and Coordinators • The standard requirement at your institution for expiration is acceptable • Medical License • Current copies are required of all PIs, Co-Is and Pharmacists, and as applicable, Study Coordinators • Upload a copy of the current license • Copies of online verifications are valid, unless a disclaimer is noted

8. People Level Documents • RAMPART 1572 • A 1572 is required for each group of investigators • Thus, multiple Spokes with different IRBs can be listed on the same 1572 as long as the study team is the same • You do not need to list all participating EMS departments • The 1572 should identify: • Anyone performing unique research functions • A representative of the EMS Leadership • Paramedics do NOT need to be listed on the 1572 • Please upload one copy for the PI into WebDCU. Once approved, you can upload the 1572 for the remaining individuals listed on the 1572.

9. People Level Documents • RAMPART Training • RAMPART Data Training • Primary Study Coordinators need to be trained in WebDCU for RAMPART • RAMPART Protocol Training • Training is mandatory for each clinical site PI and Primary Study Coordinator.

10. Spoke Level Documents • Regulatory Documents valid across Studies • IRB Federalwide Assurance • Each Spoke and EMS Entity must provide documentation of IRB Federalwide Assurance • Upload a copy of the FWA to WebDCU • Indicate the effective and expiration dates • Please visit the RAMPART Toolbox for specific instructions on obtaining FWAs for Spokes and EMS Entities

11. Spoke Level Documents • IRB Approved Documents • EFIC CC and PD Plan • Written documentation of IRB conditional approval with the full plan • CC Schedule, PD Schedule • Upload separate lists of CC and PD schedules • RAMPART Protocol v2 IRB Approval • Written documentation of the IRB approval of the protocol with clear documentation of the protocol version and approval date • Upload full IRB application and IRB letter of approval to WebDCU • RAMPART IRB Approved Informed Consent Form v1d • Written documentation of the IRB approval of the consent forms with clear documentation of the IRB approval date • Prior to submitting to your IRB, your Informed Consent Forms and Assent Forms need to be approved by the CCC (please send to Donna Harsh). • Upload Informed Consent Form and IRB letter of approval to WebDCU

12. Spoke Level Documents • Spoke Specific Documents • RAMPART Delegation of Authority Log • Each Spoke needs a Delegation of Authority Log. • Please upload a copy to WebDCU

13. EMS Level Documents • IRB Federalwide Assurance • Each Spoke and EMS Entity must provide documentation of IRB Federalwide Assurance • IRB Approved Documents • EFIC CC and PD Plan • Written documentation of IRB conditional approval with the full plan • CC Schedule, PD Schedule • Upload separate lists of CC and PD schedules • RAMPART Protocol v2 IRB Approval • Written documentation of the IRB approval of the protocol with clear documentation of the protocol version and approval date • Upload full IRB application and IRB letter of approval to WebDCU

14. EMS Level Documents • EMS Level Documents • RAMPART Regulatory Requirements Schedule • Consists of a list of steps taken to obtain EMS regulatory approval to conduct the trial • RAMPART EMS Education Schedule • This is a list of all dates/times/locations for EMS training activities for all medics • RAMPART EMS Training Log • Consists of the sign-in sheets listing attendees and their signatures for each separate training session provided locally • RAMPART EMS Department Study Approval Letter • Upload the letter from the EMS provider to the site PI indicating that they plan to participate in RAMPART • RAMPART EMS Pharmacy Control Plan • Upload full pharmacy control plan approved by Kay Vonderschmidt to WebDCU

15. Requirements for Drug Shipment • All regulatory documents complete in WebDCU • Training of all study team personnel • Completion of RAMPART Milestones

16. RAMPART • Questions? • Please print the RAMPART Regulatory Document Data Dictionary (located in the RAMPART Toolbox) • Thank you for your hard work in getting your Spokes regulatory ready!

17. PDF Files Scan – Create – Reduce File Size

18. Scanning Documents • When to Scan? • Paper documents • Unable to use Print command or PDFMaker • Signature Pages • Recommended Scan Settings • “Document Mode” • Grayscale or black and white • Resolution: 300 dpi or less

19. Creating PDF FilesAdobe Acrobat Standard or Higher • Adobe PDF Print Command • Under Print Properties, change Adobe PDF default setting to “Smallest File Size”

20. Creating PDF Files without Acrobat • Print to file and save • Upload postscript (.prn or .ps) file to PS2PDF site http://ps2pdf.com/convert.htm

21. Reducing File Size Existing PDF Files • Under File click on “Reduce File Size” • Make compatible with Acrobat 5.0 and later • Click Ok • Save file