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

Project Roster This is where you can communicate to the CCC about your Study Team This is where you can communicate to the CCC about your Study Team Please visit the Project Roster to 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. 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. REMINDER: Each study team member needs to be accounted for in the Project Roster to be included in WebDCU.

WebDCU TM Each Hub is responsible for: 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 This includes regulatory documents for ALL –Spokes –EMS Entities –Team Members

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

Required Regulatory Documents Spoke Level 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

Required Regulatory Documents EMS Level 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

People Level Documents Regulatory Documents valid across Studies 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 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 CVs must be signed and dated Valid for 1 year for PIs Valid for 1 year for PIs Valid for 2 years for all other study team members Valid for 2 years for all other study team members –HIPAA and Human Subjects Protection Certification Certification required for Investigators and Coordinators Certification required for Investigators and Coordinators The standard requirement at your institution for expiration is acceptable 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 Current copies are required of all PIs, Co-Is and Pharmacists, and as applicable, Study Coordinators Upload a copy of the current license Upload a copy of the current license Copies of online verifications are valid, unless a disclaimer is noted Copies of online verifications are valid, unless a disclaimer is noted

People Level Documents RAMPART 1572 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 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 You do not need to list all participating EMS departments –The 1572 should identify: Anyone performing unique research functions Anyone performing unique research functions A representative of the EMS Leadership A representative of the EMS Leadership Paramedics do NOT need to be listed on the 1572 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.

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

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

Spoke Level Documents IRB Approved Documents IRB Approved Documents –EFIC CC and PD Plan Written documentation of IRB conditional approval with the full plan Written documentation of IRB conditional approval with the full plan –CC Schedule, PD Schedule Upload separate lists of CC and PD schedules 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 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 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 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). 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 Upload Informed Consent Form and IRB letter of approval to WebDCU

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

EMS Level Documents IRB Federalwide Assurance IRB Federalwide Assurance –Each Spoke and EMS Entity must provide documentation of IRB Federalwide Assurance IRB Approved Documents IRB Approved Documents –EFIC CC and PD Plan Written documentation of IRB conditional approval with the full plan Written documentation of IRB conditional approval with the full plan –CC Schedule, PD Schedule Upload separate lists of CC and PD schedules 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 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 Upload full IRB application and IRB letter of approval to WebDCU

EMS Level Documents 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 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 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 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 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 Upload full pharmacy control plan approved by Kay Vonderschmidt to WebDCU

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

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

PDF Files Scan – Create – Reduce File Size

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

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

Creating PDF Files without Acrobat Print to file and save Print to file and save Upload postscript (.prn or.ps) file to PS2PDF site Upload postscript (.prn or.ps) file to PS2PDF site

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