ProTECT IIIProTECT IIIRegulatory & Project Regulatory & Project

ManagementManagement

Project Spoke TableProject Spoke Table• This is where information about your Spokes is This is where information about your Spokes is

maintainedmaintained• To ADD a Spoke for ProTECT:To ADD a Spoke for ProTECT:

– Contact Cassidy Conner (connerc@musc.edu) and Erin Contact Cassidy Conner (connerc@musc.edu) and Erin Bengelink (Bengelink (ezajaros@umich.edu) with the Hub name, ) with the Hub name, Spoke name, and ProjectSpoke name, and Project

• To EDIT information for a Spoke: To EDIT information for a Spoke: – Please visit NETT WebDCU Regulatory DatabasePlease visit NETT WebDCU Regulatory Database– Select Project Management, Project SpokeSelect Project Management, Project Spoke

• Edit and add information for existing Spoke entriesEdit and add information for existing Spoke entries• Deactivate Spokes no longer participatingDeactivate Spokes no longer participating• NOTE: Drug shipping locations and recipients (lines 13-NOTE: Drug shipping locations and recipients (lines 13-

20), and BioProTECT shipping information (lines 7-12) 20), and BioProTECT shipping information (lines 7-12) should be included hereshould be included here

• Spokes are listed separately for each Project Spokes are listed separately for each Project – Example: Emory, Grady Memorial, ProTECTExample: Emory, Grady Memorial, ProTECT– Example: Emory, The Med, ProTECTExample: Emory, The Med, ProTECT

Project Spoke Team Member Project Spoke Team Member TableTable

• This is where you can communicate to the This is where you can communicate to the CCC about your Study Team MembersCCC about your Study Team Members

• Please visit NETT WebDCU Regulatory Please visit NETT WebDCU Regulatory DatabaseDatabase– Select Project Management, Project Spoke Team Select Project Management, Project Spoke Team

MemberMember• Add new study team personnel to ProTECT Add new study team personnel to ProTECT • Edit existing entriesEdit existing entries• Deactivate study team personnel no longer Deactivate study team personnel no longer

participatingparticipating• NOTE: Study team members must first be added to the NOTE: Study team members must first be added to the

People TablePeople Table, but this only needs to occur once, but this only needs to occur once

• Study team members need to be included Study team members need to be included for their roles on each Project, at each for their roles on each Project, at each Spoke. Spoke. – Example: John Doe, Co-I, ProTECT, Grady MemorialExample: John Doe, Co-I, ProTECT, Grady Memorial– Example: John Doe, Co-I, ProTECT, The MedExample: John Doe, Co-I, ProTECT, The Med

Project Management Project Management ReminderReminder

• Each Spoke needs to be accounted for in Each Spoke needs to be accounted for in WebDCU for each ProjectWebDCU for each Project

• The role of each study team member for each The role of each study team member for each Project at each Spoke needs to be accounted for Project at each Spoke needs to be accounted for in WebDCUin WebDCU

When new team members and/or new Spokes are When new team members and/or new Spokes are added, regulatory requirements will populate added, regulatory requirements will populate

Remember to update 1572s and Delegation of Remember to update 1572s and Delegation of Authority Logs per the changesAuthority Logs per the changes

Notify local IRB of change in study team Notify local IRB of change in study team personnel and/or Spokes and upload personnel and/or Spokes and upload documentation in WebDCUdocumentation in WebDCU

Reconcile all other training and regulatory Reconcile all other training and regulatory requirements for the new personnel/Spokesrequirements for the new personnel/Spokes

Participation in trials cannot begin until these Participation in trials cannot begin until these requirements are metrequirements are met

NETT Regulatory NETT Regulatory ComplianceCompliance

• Each Hub is responsible for:Each Hub is responsible for:– Ensuring all required regulatory Ensuring all required regulatory

documentation is current in WebDCU documentation is current in WebDCU – Checking WebDCU regularly for rejected Checking WebDCU regularly for rejected

documents and documents nearing expirationdocuments and documents nearing expiration– Regulatory documents should not be allowed Regulatory documents should not be allowed

to expire in WebDCU to expire in WebDCU

• This includes regulatory documents for This includes regulatory documents for ALLALL– SpokesSpokes– Study Team MembersStudy Team Members

Required Required Regulatory DocumentsRegulatory Documents

• People Level People Level DocumentsDocumentsProject SpecificProject Specific•ProTECT 1572ProTECT 1572•ProTECT Protocol Training ProTECT Protocol Training •ProTECT Data Training ProTECT Data Training CertificationCertification•ProTECT Site Pharmacy Data ProTECT Site Pharmacy Data Training CertificationTraining Certification•ProTECT NP Outcomes Training ProTECT NP Outcomes Training •ProTECT PI Attestation of Study ProTECT PI Attestation of Study Team Education and Training Team Education and Training (one per Spoke)(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 Required Regulatory DocumentsRegulatory Documents

• Spoke Level DocumentsSpoke 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 Results IRB 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 Form IRB 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• CLIA CLIA • Federalwide Assurance (FWA)Federalwide Assurance (FWA)

People Level DocumentsPeople Level Documents• People Documents valid across all NETT Studies (Non Project People Documents valid across all NETT Studies (Non Project

Specific)Specific)– Curriculum VitaeCurriculum Vitae

• CVs must be signed and dated CVs must be signed and dated • Valid 5 years Valid 5 years

– HIPAA and Human Subjects Protection CertificationHIPAA and Human Subjects Protection Certification• The standard requirement at your institution for The standard requirement at your institution for

approval period is acceptable. Please forward approval period is acceptable. Please forward documentation of these policies to Ben Hume (documentation of these policies to Ben Hume (bhume@med.umich.edu).).

– Medical LicenseMedical License• Upload a copy of the current licenseUpload a copy of the current license• Copies of online verifications are valid, unless a Copies of online verifications are valid, unless a

disclaimer is noted disclaimer is noted – Sample Handling and Shipping Certification Sample Handling and Shipping Certification

• The standard requirement at your institution for The standard requirement at your institution for shipping/handling samples is acceptable. shipping/handling samples is acceptable.

NOTE: Please reference parameters document for NOTE: Please reference parameters document for specific requirements by rolespecific requirements by role

People Level DocumentsPeople Level Documents• ProTECTProTECT 1572 (Project Specific)1572 (Project Specific)

– A 1572 is required for each group of A 1572 is required for each group of investigators investigators •Thus, multiple Spokes with different Thus, multiple Spokes with different

IRBs can be listed on the same 1572 as IRBs can be listed on the same 1572 as long as the study team is the samelong as the study team is the same

– The 1572 should identify:The 1572 should identify:•Anyone performing unique research Anyone performing unique research

functionsfunctions•Those administering outcomes Those administering outcomes

assessments should be includedassessments should be included– For each Spoke, create one entry in For each Spoke, create one entry in

WebDCU and apply it to all study team WebDCU and apply it to all study team members listed on the 1572members listed on the 1572

People Level DocumentsPeople Level Documents• ProTECT Training (Non Study Specific)ProTECT Training (Non Study Specific)

– GOAT Certification GOAT Certification – GOSE CertificationGOSE Certification– DRS CertificationDRS Certification– NIHSS CertificationNIHSS Certification– NOS-TBI Certification NOS-TBI Certification

Training is mandatory for all clinical site Investigators Training is mandatory for all clinical site Investigators and Study Coordinators completing these assessmentsand Study Coordinators completing these assessments

GOSE is required initially for all Trial PIs and Primary GOSE is required initially for all Trial PIs and Primary Study CoordinatorsStudy Coordinators

DRS is required initially for all Primary Study DRS is required initially for all Primary Study CoordinatorsCoordinators

Documentation of each certification should be uploaded Documentation of each certification should be uploaded in WebDCUin WebDCU

People Level DocumentsPeople Level Documents• ProTECT Training (Project Specific)ProTECT Training (Project Specific)

– ProTECT Data TrainingProTECT Data Training• Anyone who needs access to the ProTECT database must Anyone who needs access to the ProTECT database must

complete training prior to access being granted complete training prior to access being granted – ProTECTProTECT Pharmacy Data TrainingPharmacy Data Training

• Study Drug Recipients need to be trained in WebDCU for Study Drug Recipients need to be trained in WebDCU for ProTECTProTECT prior to access being granted prior to access being granted

– ProTECT Protocol TrainingProTECT Protocol Training• Training for all ProTECT study team members with the Training for all ProTECT study team members with the

exception of pharmacists and NP Site Examiners exception of pharmacists and NP Site Examiners – ProTECT PI Attestation of Training and EducationProTECT 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 SpokeRequired by Trial PI for each Spoke

– NP Outcomes Training and Certification NP Outcomes Training and Certification • Training is mandatory for each Site NP Examiner Training is mandatory for each Site NP Examiner

performing these assessmentsperforming these assessments

Spoke Level DocumentsSpoke Level Documents• Regulatory Documents valid across all NETT Regulatory Documents valid across all NETT

Studies (Non Project Specific)Studies (Non Project Specific)– Federalwide AssuranceFederalwide Assurance

• Each Spoke must provide documentation of Federalwide Each Spoke must provide documentation of Federalwide AssuranceAssurance

• All IRBs reviewing ProTECT must be tied to the Spoke All IRBs reviewing ProTECT must be tied to the Spoke FWAFWA

• Please visit the ProTECT Toolbox for specific instructions Please visit the ProTECT Toolbox for specific instructions on obtaining FWAs for Spokeson obtaining FWAs for Spokes

– CLIA CLIA • Each Spoke must maintain documentation of laboratory Each Spoke must maintain documentation of laboratory

certificationcertification

Spoke Level DocumentsSpoke Level Documents• IRB Approved Documents IRB Approved Documents

– EFIC CC and PD Plan IRB Submission and ApprovalEFIC 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 Written documentation of IRB conditional approval of the full

EFIC planEFIC plan– ProTECT Protocol v7 IRB Submission and ApprovalProTECT Protocol v7 IRB Submission and Approval

• Written documentation of IRB submission of Protocol v7 and Written documentation of IRB submission of Protocol v7 and Community Consultation results Community Consultation results

• 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, review of CC clear documentation of the protocol version, review of CC results and approval period results and approval period

– ProTECT IRB Approved Notification Letter to LARProTECT IRB Approved Notification Letter to LAR• Written documentation of the IRB approval of the letter with Written documentation of the IRB approval of the letter with

clear documentation of the IRB approval periodclear documentation of the IRB approval period

Spoke Level DocumentsSpoke Level Documents• IRB Approved Consent Documents IRB Approved Consent Documents

– ProTECT IRB Approved Informed Consent FormProTECT IRB Approved Informed Consent Form• Written documentation of the IRB approval of the consent Written documentation of the IRB approval of the consent

forms with clear documentation of the IRB approval periodforms with clear documentation of the IRB approval period• Prior to submitting to your IRB, Informed Consent Forms need Prior to submitting to your IRB, Informed Consent Forms need

to be approved by the CCC (please send to to be approved by the CCC (please send to ProTECT-milestone@umich.edu).).

– ProTECT IRB Approved Revocation FormProTECT IRB Approved Revocation Form• Written documentation of the IRB approval of the letter with Written documentation of the IRB approval of the letter with

clear documentation of the IRB approval periodclear documentation of the IRB approval period– ProTECT IRB Approved Participation without Study Drug ProTECT IRB Approved Participation without Study Drug

• Written documentation of the IRB approval of the letter with Written documentation of the IRB approval of the letter with clear documentation of the IRB approval periodclear documentation of the IRB approval period

– ProTECTProTECT IRB Approved Video ConsentIRB Approved Video Consent• Written documentation of the IRB approval of the letter with Written documentation of the IRB approval of the letter with

clear documentation of the IRB approval periodclear documentation of the IRB approval period

NOTE: Templates available in the ProTECT ToolboxNOTE: Templates available in the ProTECT Toolbox

Spoke Level DocumentsSpoke Level Documents• Spoke Specific Documents Spoke Specific Documents

– ProTECT Delegation of Authority LogProTECT Delegation of Authority Log• Each Spoke needs a Delegation of Authority LogEach Spoke needs a Delegation of Authority Log• Each team member needs to sign next to their Each team member needs to sign next to their

responsibilitiesresponsibilities• All responsibilities need to be accounted forAll responsibilities need to be accounted for• Update with each change in study team personnel and Update with each change in study team personnel and

responsibilities (initial/date all changes) responsibilities (initial/date all changes)

– Pharmacy PlanPharmacy Plan• Documentation of drug disposal planDocumentation of drug disposal plan• Documentation of study drug storageDocumentation of study drug storage• Documentation of temperature monitoring Documentation of temperature monitoring

Requirements for Drug Requirements for Drug ShipmentShipment

• All regulatory documents reconciled in All regulatory documents reconciled in WebDCUWebDCU

• Training of all study team personnel with Training of all study team personnel with appropriate documentation in WebDCUappropriate documentation in WebDCU

• Completion of ProTECT Milestones Completion of ProTECT Milestones through Task 12through Task 12

• Completion of Site Initiation Visit and Completion of Site Initiation Visit and ProTECT Readiness conference callProTECT Readiness conference call

Helpful ProTECTHelpful ProTECT DocumentsDocuments

• ProTECT Milestone Document ProTECT Milestone Document – Located in the ProTECTLocated in the ProTECT Toolbox Toolbox

• ProTECT Regulatory Approval Parameters ProTECT Regulatory Approval Parameters DocumentDocument– Located in WebDCU: Project Management > Project Located in WebDCU: Project Management > Project

DocumentsDocuments

• Readiness Checklist Readiness Checklist – Located in the ProTECT Toolbox Located in the ProTECT Toolbox

• IRB Resources, including consent templatesIRB Resources, including consent templates– Located in the ProTECT Toolbox Located in the ProTECT Toolbox

• Informed Consent Documents – Storage Informed Consent Documents – Storage – If a specific time is referenced for storage, If a specific time is referenced for storage,

it should reflect the FDA guidelinesit should reflect the FDA guidelines

• Video Consent – Subject IDVideo Consent – Subject ID– Please remove the Subject ID line Please remove the Subject ID line

• LAR Notification Letter LAR Notification Letter – Please update to reflect the template in the Please update to reflect the template in the

ProTECT Toolbox ProTECT Toolbox

Updates to ProTECT Updates to ProTECT DocumentsDocuments

• ProTECT III has a Certificate of ProTECT III has a Certificate of Confidentiality (CoC) from the FDA.Confidentiality (CoC) from the FDA.

• To apply to be covered under the ProTECT To apply to be covered under the ProTECT CoC, please follow instructions provided in CoC, please follow instructions provided in ProTECT Toolbox, under IRB Resources.ProTECT Toolbox, under IRB Resources.

• Please include language specific to the Please include language specific to the CoC in Informed Consent Forms (template CoC in Informed Consent Forms (template to be posted in the ProTECT Toolbox)to be posted in the ProTECT Toolbox)

ProTECT Certificate of ProTECT Certificate of ConfidentialityConfidentiality

ProTECTProTECT

• Questions? Questions?

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