ProTECT III Regulatory & Project Management

Project Spoke Table This is where information about your Spokes is maintained This is where information about your Spokes is maintained To ADD a Spoke for ProTECT: To ADD a Spoke for ProTECT: –Contact Cassidy Conner and Erin Bengelink with the Hub name, Spoke name, and Project To EDIT information for a Spoke: To EDIT information for a Spoke: –Please visit NETT WebDCU Regulatory Database –Select Project Management, Project Spoke Edit and add information for existing Spoke entries Edit and add information for existing Spoke entries Deactivate Spokes no longer participating Deactivate Spokes no longer participating NOTE: Drug shipping locations and recipients (lines ), and BioProTECT shipping information (lines 7-12) should be included here NOTE: Drug shipping locations and recipients (lines ), and BioProTECT shipping information (lines 7-12) should be included here Spokes are listed separately for each Project Spokes are listed separately for each Project –Example: Emory, Grady Memorial, ProTECT –Example: Emory, The Med, ProTECT

Project Spoke Team Member Table This is where you can communicate to the CCC about your Study Team Members This is where you can communicate to the CCC about your Study Team Members Please visit NETT WebDCU Regulatory Database Please visit NETT WebDCU Regulatory Database –Select Project Management, Project Spoke Team Member Add new study team personnel to ProTECT Add new study team personnel to ProTECT Edit existing entries Edit existing entries Deactivate study team personnel no longer participating Deactivate study team personnel no longer participating NOTE: Study team members must first be added to the People Table, but this only needs to occur once NOTE: Study team members must first be added to the People Table, but this only needs to occur once 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, ProTECT, Grady Memorial –Example: John Doe, Co-I, ProTECT, The Med

Project Management Reminder Each Spoke needs to be accounted for in WebDCU for each Project Each Spoke needs to be accounted for in WebDCU for each Project The role of each study team member for each Project at each Spoke needs to be accounted for in WebDCU The role of each study team member for each Project at each Spoke needs to be accounted for in WebDCU  When new team members and/or new Spokes are added, regulatory requirements will populate  Remember to update 1572s and Delegation of Authority Logs per the changes  Notify local IRB of change in study team personnel and/or Spokes and upload documentation in WebDCU  Reconcile all other training and regulatory requirements for the new personnel/Spokes  Participation in trials cannot begin until these requirements are met

NETT Regulatory Compliance Each Hub is responsible for: Each Hub is responsible for: –Ensuring all required regulatory documentation is current in WebDCU –Checking WebDCU regularly for rejected documents and documents nearing expiration –Regulatory documents should not be allowed to expire in WebDCU This includes regulatory documents for ALL This includes regulatory documents for ALL –Spokes –Study Team Members

Required Regulatory Documents People Level Documents People Level Documents Project Specific ProTECT 1572ProTECT 1572 ProTECT Protocol TrainingProTECT Protocol Training ProTECT Data Training CertificationProTECT Data Training Certification ProTECT Site Pharmacy Data Training CertificationProTECT Site Pharmacy Data Training Certification ProTECT NP Outcomes TrainingProTECT NP Outcomes Training ProTECT PI Attestation of Study Team Education and Training (one per Spoke)ProTECT PI Attestation of Study Team Education and Training (one per Spoke) Non Project Specific DRS Certification GOAT Certification GOSE Certification NIHSS Certification NOS-TBI Certification Human Subjects Protection Certification HIPAA Training Certification Medical License CV Sample Handling and Shipping Certification

Required Regulatory Documents Spoke Level Documents Spoke Level Documents Documentation of IRB submission of EFIC PlanDocumentation of IRB submission of EFIC Plan IRB approval of EFIC planIRB approval of EFIC plan Documentation of IRB submission of Full Study IRB ApplicationDocumentation of IRB submission of Full Study IRB Application IRB approval of ProTECT Protocol Version 7/Full Study/EFIC ResultsIRB approval of ProTECT Protocol Version 7/Full Study/EFIC Results IRB Approved Informed Consent FormIRB Approved Informed Consent Form IRB Approved Revocation FormIRB Approved Revocation Form IRB Approved Participation without Study Drug LetterIRB Approved Participation without Study Drug Letter IRB Approved Video Consent FormIRB Approved Video Consent Form IRB approval of Notification Letter to LARIRB approval of Notification Letter to LAR ProTECT Delegation of Authority LogProTECT Delegation of Authority Log ProTECT Pharmacy PlanProTECT Pharmacy Plan CLIACLIA Federalwide Assurance (FWA)Federalwide Assurance (FWA)

People Level Documents People Documents valid across all NETT Studies (Non Project Specific) People Documents valid across all NETT Studies (Non Project Specific) –Curriculum Vitae CVs must be signed and dated CVs must be signed and dated Valid 5 years Valid 5 years –HIPAA and Human Subjects Protection Certification The standard requirement at your institution for approval period is acceptable. Please forward documentation of these policies to Ben Hume The standard requirement at your institution for approval period is acceptable. Please forward documentation of these policies to Ben Hume –Medical License 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 –Sample Handling and Shipping Certification The standard requirement at your institution for shipping/handling samples is acceptable. The standard requirement at your institution for shipping/handling samples is acceptable. NOTE: Please reference parameters document for specific requirements by role

People Level Documents ProTECT 1572 (Project Specific) ProTECT 1572 (Project Specific) –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 –The 1572 should identify: Anyone performing unique research functions Anyone performing unique research functions Those administering outcomes assessments should be included Those administering outcomes assessments should be included –For each Spoke, create one entry in WebDCU and apply it to all study team members listed on the 1572

People Level Documents ProTECT Training (Non Study Specific) ProTECT Training (Non Study Specific) –GOAT Certification –GOSE Certification –DRS Certification –NIHSS Certification –NOS-TBI Certification  Training is mandatory for all clinical site Investigators and Study Coordinators completing these assessments  GOSE is required initially for all Trial PIs and Primary Study Coordinators  DRS is required initially for all Primary Study Coordinators  Documentation of each certification should be uploaded in WebDCU

People Level Documents ProTECT Training (Project Specific) ProTECT Training (Project Specific) –ProTECT Data Training Anyone who needs access to the ProTECT database must complete training prior to access being granted Anyone who needs access to the ProTECT database must complete training prior to access being granted –ProTECT Pharmacy Data Training Study Drug Recipients need to be trained in WebDCU for ProTECT prior to access being granted Study Drug Recipients need to be trained in WebDCU for ProTECT prior to access being granted –ProTECT Protocol Training Training for all ProTECT study team members with the exception of pharmacists and NP Site Examiners Training for all ProTECT study team members with the exception of pharmacists and NP Site Examiners –ProTECT PI Attestation of Training and Education Signature page of v7 of the protocol (page 6) Signature page of v7 of the protocol (page 6) Required by Trial PI for each Spoke Required by Trial PI for each Spoke –NP Outcomes Training and Certification Training is mandatory for each Site NP Examiner performing these assessments Training is mandatory for each Site NP Examiner performing these assessments

Spoke Level Documents Regulatory Documents valid across all NETT Studies (Non Project Specific) Regulatory Documents valid across all NETT Studies (Non Project Specific) –Federalwide Assurance Each Spoke must provide documentation of Federalwide Assurance Each Spoke must provide documentation of Federalwide Assurance All IRBs reviewing ProTECT must be tied to the Spoke FWA All IRBs reviewing ProTECT must be tied to the Spoke FWA Please visit the ProTECT Toolbox for specific instructions on obtaining FWAs for Spokes Please visit the ProTECT Toolbox for specific instructions on obtaining FWAs for Spokes –CLIA Each Spoke must maintain documentation of laboratory certification Each Spoke must maintain documentation of laboratory certification

Spoke Level Documents IRB Approved Documents IRB Approved Documents –EFIC CC and PD Plan IRB Submission and Approval Written documentation of IRB submission of the full EFIC plan Written documentation of IRB submission of the full EFIC plan Written documentation of IRB conditional approval of the full EFIC plan Written documentation of IRB conditional approval of the full EFIC plan –ProTECT Protocol v7 IRB Submission and Approval Written documentation of IRB submission of Protocol v7 and Community Consultation results Written documentation of IRB submission of Protocol v7 and Community Consultation results Written documentation of the IRB approval of the protocol with clear documentation of the protocol version, review of CC results and approval period Written documentation of the IRB approval of the protocol with clear documentation of the protocol version, review of CC results and approval period –ProTECT IRB Approved Notification Letter to LAR Written documentation of the IRB approval of the letter with clear documentation of the IRB approval period Written documentation of the IRB approval of the letter with clear documentation of the IRB approval period

Spoke Level Documents IRB Approved Consent Documents IRB Approved Consent Documents –ProTECT IRB Approved Informed Consent Form Written documentation of the IRB approval of the consent forms with clear documentation of the IRB approval period Written documentation of the IRB approval of the consent forms with clear documentation of the IRB approval period Prior to submitting to your IRB, Informed Consent Forms need to be approved by the CCC (please send to Prior to submitting to your IRB, Informed Consent Forms need to be approved by the CCC (please send to –ProTECT IRB Approved Revocation Form Written documentation of the IRB approval of the letter with clear documentation of the IRB approval period Written documentation of the IRB approval of the letter with clear documentation of the IRB approval period –ProTECT IRB Approved Participation without Study Drug Written documentation of the IRB approval of the letter with clear documentation of the IRB approval period Written documentation of the IRB approval of the letter with clear documentation of the IRB approval period –ProTECT IRB Approved Video Consent Written documentation of the IRB approval of the letter with clear documentation of the IRB approval period Written documentation of the IRB approval of the letter with clear documentation of the IRB approval period NOTE: Templates available in the ProTECT Toolbox

Spoke Level Documents Spoke Specific Documents Spoke Specific Documents –ProTECT Delegation of Authority Log Each Spoke needs a Delegation of Authority Log Each Spoke needs a Delegation of Authority Log Each team member needs to sign next to their responsibilities Each team member needs to sign next to their responsibilities All responsibilities need to be accounted for All responsibilities need to be accounted for Update with each change in study team personnel and responsibilities (initial/date all changes) Update with each change in study team personnel and responsibilities (initial/date all changes) –Pharmacy Plan Documentation of drug disposal plan Documentation of drug disposal plan Documentation of study drug storage Documentation of study drug storage Documentation of temperature monitoring Documentation of temperature monitoring

Requirements for Drug Shipment All regulatory documents reconciled in WebDCU All regulatory documents reconciled in WebDCU Training of all study team personnel with appropriate documentation in WebDCU Training of all study team personnel with appropriate documentation in WebDCU Completion of ProTECT Milestones through Task 12 Completion of ProTECT Milestones through Task 12 Completion of Site Initiation Visit and ProTECT Readiness conference call Completion of Site Initiation Visit and ProTECT Readiness conference call

Helpful ProTECT Documents ProTECT Milestone Document ProTECT Milestone Document –Located in the ProTECT Toolbox ProTECT Regulatory Approval Parameters Document ProTECT Regulatory Approval Parameters Document –Located in WebDCU: Project Management > Project Documents Readiness Checklist Readiness Checklist –Located in the ProTECT Toolbox IRB Resources, including consent templates IRB Resources, including consent templates –Located in the ProTECT Toolbox

Informed Consent Documents – Storage Informed Consent Documents – Storage –If a specific time is referenced for storage, it should reflect the FDA guidelines Video Consent – Subject ID Video Consent – Subject ID –Please remove the Subject ID line LAR Notification Letter LAR Notification Letter –Please update to reflect the template in the ProTECT Toolbox Updates to ProTECT Documents

ProTECT III has a Certificate of Confidentiality (CoC) from the FDA. ProTECT III has a Certificate of Confidentiality (CoC) from the FDA. To apply to be covered under the ProTECT CoC, please follow instructions provided in ProTECT Toolbox, under IRB Resources. To apply to be covered under the ProTECT CoC, please follow instructions provided in ProTECT Toolbox, under IRB Resources. Please include language specific to the CoC in Informed Consent Forms (template to be posted in the ProTECT Toolbox) Please include language specific to the CoC in Informed Consent Forms (template to be posted in the ProTECT Toolbox) ProTECT Certificate of Confidentiality

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