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

Neurological Neurological Emergencies Emergencies Treatment Trials Treatment Trials NetworkNetwork

RAMPARTRAMPART

This award is funded with support of NINDS, BARDA This award is funded with support of NINDS, BARDA and the NIH CounterACT program.and the NIH CounterACT program.

Project RosterProject Roster

This is where you can communicate to the This is where you can communicate to the CCC about your Study TeamCCC about your Study Team

Please visit the Project Roster toPlease visit the Project Roster to– Update incorrect informationUpdate incorrect information– Add new study team personnel Add new study team personnel – Remove study team personnel no longer Remove study team personnel no longer

participatingparticipating Study team members need to be included for Study team members need to be included for

their roles on each project, at each spoke. their roles on each project, at each spoke. – Example: John Doe, Co-I, RAMPART, Site 1Example: John Doe, Co-I, RAMPART, Site 1– Example: John Doe, Co-I, RAMPART, Site 4Example: John Doe, Co-I, RAMPART, Site 4

REMINDER:REMINDER: Each study team member needs Each study team member needs to be accounted for in the Project Roster to be to be accounted for in the Project Roster to be included in WebDCU.included in WebDCU.

WebDCUWebDCUTMTM

Each Hub is responsible for:Each Hub is responsible for:– Ensuring all required documentation is Ensuring all required documentation is

current in WebDCU current in WebDCU – Checking WebDCU regularly for expired Checking WebDCU regularly for expired

and rejected documents and rejected documents This includes regulatory documents for This includes regulatory documents for

ALLALL– SpokesSpokes– EMS Entities EMS Entities – Team MembersTeam Members

Required Required Regulatory DocumentsRegulatory Documents People Level DocumentsPeople Level Documents

– Curriculum VitaeCurriculum Vitae– HIPAA CertificationHIPAA Certification– Human Subjects Protection CertificationHuman Subjects Protection Certification– Medical LicenseMedical License– RAMPART Protocol TrainingRAMPART Protocol Training– RAMPART Data Training RAMPART Data Training – RAMPART 1572 RAMPART 1572

Required Required Regulatory DocumentsRegulatory Documents Spoke Level DocumentsSpoke Level Documents

– RAMPART EFIC CC & PD PlanRAMPART EFIC CC & PD Plan– RAMPART CC ScheduleRAMPART CC Schedule– RAMPART PD ScheduleRAMPART PD Schedule– IRB Federalwide AssuranceIRB Federalwide Assurance– RAMPART Protocol v2 IRB Approval RAMPART Protocol v2 IRB Approval – RAMPART IRB Approved Informed Consent Form RAMPART IRB Approved Informed Consent Form

v1dv1d– RAMPART IRB Approved Patient Notification FormsRAMPART IRB Approved Patient Notification Forms– RAMPART Delegation of Authority LogRAMPART Delegation of Authority Log

Required Required Regulatory DocumentsRegulatory Documents EMS Level DocumentsEMS Level Documents

– RAMPART EFIC CC & PD PlanRAMPART EFIC CC & PD Plan– RAMPART CC ScheduleRAMPART CC Schedule– RAMPART PD ScheduleRAMPART PD Schedule– IRB Federalwide AssuranceIRB Federalwide Assurance– RAMPART Protocol v2 IRB Approval RAMPART Protocol v2 IRB Approval – RAMPART Regulatory Requirements ScheduleRAMPART Regulatory Requirements Schedule– RAMPART EMS Education ScheduleRAMPART EMS Education Schedule– RAMPART EMS Training Log RAMPART EMS Training Log – RAMPART EMS Department Study Approval LetterRAMPART EMS Department Study Approval Letter– RAMPART EMS Pharmacy Control PlanRAMPART EMS Pharmacy Control Plan

People Level People Level DocumentsDocuments Regulatory Documents valid across StudiesRegulatory Documents valid across Studies

– Curriculum VitaeCurriculum Vitae Required for all site personnel listed on the 1572, Study Required for all site personnel listed on the 1572, Study

Coordinators, EMS Coordinators, and any other personnel Coordinators, EMS Coordinators, and any other personnel directly involved in the study directly involved in the study

CVs must be signed and dated CVs must be signed and dated Valid for 1 year for PIsValid for 1 year for PIs Valid for 2 years for all other study team membersValid for 2 years for all other study team members

– HIPAA and Human Subjects Protection CertificationHIPAA 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 The standard requirement at your institution for expiration is

acceptableacceptable– Medical LicenseMedical License

Current copies are required of all PIs, Co-Is and Pharmacists, Current copies are required of all PIs, Co-Is and Pharmacists, and as applicable, Study Coordinatorsand as applicable, Study Coordinators

Upload a copy of the current licenseUpload a copy of the current license Copies of online verifications are valid, unless a disclaimer is Copies of online verifications are valid, unless a disclaimer is

noted noted

People Level People Level DocumentsDocuments

RAMPART 1572RAMPART 1572– A 1572 is required for each group of A 1572 is required for each group of

investigators investigators Thus, multiple Spokes with different IRBs can be Thus, multiple Spokes with different IRBs can be

listed on the same 1572 as long as the study team listed on the same 1572 as long as the study team is the sameis the same

You do not need to list all participating EMS You do not need to list all participating EMS departmentsdepartments

– The 1572 should identify:The 1572 should identify: Anyone performing unique research functionsAnyone 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 1572Paramedics do NOT need to be listed on the 1572

– Please upload one copy for the PI into Please upload one copy for the PI into WebDCU. Once approved, you can upload WebDCU. Once approved, you can upload the 1572 for the remaining individuals listed the 1572 for the remaining individuals listed on the 1572. on the 1572.

People Level People Level DocumentsDocuments RAMPART TrainingRAMPART Training

– RAMPART Data TrainingRAMPART Data Training Primary Study Coordinators need to be Primary Study Coordinators need to be

trained in WebDCU for RAMPARTtrained in WebDCU for RAMPART– RAMPART Protocol TrainingRAMPART Protocol Training

Training is mandatory for each clinical Training is mandatory for each clinical site PI and Primary Study Coordinator. site PI and Primary Study Coordinator.

Spoke Level Spoke Level DocumentsDocuments

Regulatory Documents valid across Regulatory Documents valid across StudiesStudies– IRB Federalwide AssuranceIRB Federalwide Assurance

Each Spoke and EMS Entity must provide Each Spoke and EMS Entity must provide documentation of IRB Federalwide Assurancedocumentation of IRB Federalwide Assurance

Upload a copy of the FWA to WebDCUUpload 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 Please visit the RAMPART Toolbox for specific instructions on obtaining FWAs for specific instructions on obtaining FWAs for Spokes and EMS Entities Spokes and EMS Entities


IRB Approved Documents IRB Approved Documents – EFIC CC and PD PlanEFIC CC and PD Plan

Written documentation of IRB conditional approval with the full Written documentation of IRB conditional approval with the full planplan

– CC Schedule, PD ScheduleCC Schedule, PD Schedule Upload separate lists of CC and PD schedules Upload separate lists of CC and PD schedules

– RAMPART Protocol v2 IRB ApprovalRAMPART Protocol v2 IRB Approval Written documentation of the IRB approval of the protocol with Written documentation of the IRB approval of the protocol with

clear documentation of the protocol version and approval dateclear documentation of the protocol version and approval date Upload full IRB application and IRB letter of approval to WebDCUUpload full IRB application and IRB letter of approval to WebDCU

– RAMPART IRB Approved Informed Consent Form v1dRAMPART IRB Approved Informed Consent Form v1d Written documentation of the IRB approval of the consent forms Written documentation of the IRB approval of the consent forms

with clear documentation of the IRB approval datewith clear documentation of the IRB approval date Prior to submitting to your IRB, your Informed Consent Forms and Prior to submitting to your IRB, your Informed Consent Forms and

Assent Forms need to be approved by the CCC (please send to Assent Forms need to be approved by the CCC (please send to Donna Harsh).Donna Harsh).

Upload Informed Consent Form and IRB letter of approval to Upload Informed Consent Form and IRB letter of approval to WebDCUWebDCU


Spoke Specific Documents Spoke Specific Documents – RAMPART Delegation of Authority LogRAMPART Delegation of Authority Log

Each Spoke needs a Delegation of Authority Each Spoke needs a Delegation of Authority Log.Log.

Please upload a copy to WebDCUPlease upload a copy to WebDCU

EMS Level DocumentsEMS Level Documents

IRB Federalwide AssuranceIRB Federalwide Assurance– Each Spoke and EMS Entity must provide Each Spoke and EMS Entity must provide

documentation of IRB Federalwide Assurancedocumentation of IRB Federalwide Assurance IRB Approved Documents IRB Approved Documents

– EFIC CC and PD PlanEFIC CC and PD Plan Written documentation of IRB conditional approval with Written documentation of IRB conditional approval with

the full planthe full plan– CC Schedule, PD ScheduleCC Schedule, PD Schedule

Upload separate lists of CC and PD schedules Upload separate lists of CC and PD schedules – RAMPART Protocol v2 IRB ApprovalRAMPART Protocol v2 IRB Approval

Written documentation of the IRB approval of the Written documentation of the IRB approval of the protocol with clear documentation of the protocol protocol with clear documentation of the protocol version and approval dateversion and approval date

Upload full IRB application and IRB letter of approval to Upload full IRB application and IRB letter of approval to WebDCUWebDCU

EMS Level Documents EMS Level Documents

EMS Level DocumentsEMS Level Documents– RAMPART Regulatory Requirements ScheduleRAMPART Regulatory Requirements Schedule

Consists of a list of steps taken to obtain EMS regulatory Consists of a list of steps taken to obtain EMS regulatory approval to conduct the trial approval to conduct the trial

– RAMPART EMS Education ScheduleRAMPART EMS Education Schedule This is a list of all dates/times/locations for EMS training This is a list of all dates/times/locations for EMS training

activities for all medicsactivities for all medics– RAMPART EMS Training LogRAMPART EMS Training Log

Consists of the sign-in sheets listing attendees and their Consists of the sign-in sheets listing attendees and their signatures for each separate training session provided locally signatures for each separate training session provided locally

– RAMPART EMS Department Study Approval LetterRAMPART EMS Department Study Approval Letter Upload the letter from the EMS provider to the site PI Upload the letter from the EMS provider to the site PI

indicating that they plan to participate in RAMPARTindicating that they plan to participate in RAMPART– RAMPART EMS Pharmacy Control PlanRAMPART EMS Pharmacy Control Plan

Upload full pharmacy control plan approved by Kay Upload full pharmacy control plan approved by Kay Vonderschmidt to WebDCUVonderschmidt to WebDCU

Requirements for Drug Requirements for Drug ShipmentShipment All regulatory documents All regulatory documents

complete in WebDCU complete in WebDCU Training of all study team Training of all study team

personnelpersonnel Completion of RAMPART Completion of RAMPART

Milestones Milestones

RAMPARTRAMPART

Questions? Questions? Please print the RAMPART Please print the RAMPART

Regulatory Document Data Regulatory Document Data Dictionary (located in the Dictionary (located in the RAMPART Toolbox) RAMPART Toolbox)

Thank you for your hard work in Thank you for your hard work in getting your Spokes regulatory getting your Spokes regulatory ready!ready!

PDF FilesPDF FilesScan – Create – Reduce File SizeScan – Create – Reduce File Size

Scanning DocumentsScanning Documents

When to Scan?When to Scan?– Paper Paper

documentsdocuments

– Unable to use Unable to use Print command Print command or PDFMakeror PDFMaker

– Signature Signature PagesPages

RecommendeRecommended Scan d Scan SettingsSettings– ““Document Document

Mode”Mode”

– Grayscale or Grayscale or black and whiteblack and white

– Resolution: 300 Resolution: 300 dpi or lessdpi or less

Creating PDF FilesCreating PDF Files Adobe Acrobat Standard or HigherAdobe Acrobat Standard or Higher

Adobe PDF Print Adobe PDF Print CommandCommand

Under Print Under Print Properties, change Properties, change Adobe PDF default Adobe PDF default setting to setting to “Smallest File “Smallest File Size”Size”

Creating PDF Files Creating PDF Files without Acrobatwithout Acrobat

Print to file and Print to file and savesave

Upload postscript Upload postscript (.prn or .ps) file (.prn or .ps) file to PS2PDF siteto PS2PDF site

http://ps2pdf.com/convert.htm

Reducing File Size Reducing File Size Existing PDF FilesExisting PDF Files

Under File click Under File click on “Reduce File on “Reduce File Size”Size”

Make compatible Make compatible with Acrobat 5.0 with Acrobat 5.0 and laterand later

Click OkClick Ok Save file Save file