Registration and Credential Repository (RCR) Update and

Demo

Matthew Boron, RPhPMB, CTEP, NCI

November2-3,2017

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Goals and Objectives

• DescribewhytheRegistrationandCredentialRepository

wasimplemented

• ExplainhowtoaccesstheRCRsystem

• Providealivesystemdemonstration

• Demonstratehowdocumentsaresignedandsubmitted

totheNCI

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July 31, 2017 February 2018

RCR released

toproductio

n

August 24, 2017

DTLreleased

toproduction

September 2017

BeginDTL Pilot

Phase

October 2017

Enhanced reporting

capabilities

ExtendDTL Pilot

NCI’sRegistrationandCredentialRepositoryandDelegationofTasks LogApplications- Timelines

December 2017

DeployRCR

FeatureEnhancements

3Q 2018

First RCRRegistratio

n cycle complete

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Registration and Credential Repository

• CollectsinformationthatisusedtoverifythequalificationsofpersonnelconductingresearchactivitiesonNCI-sponsoredclinicaltrials(e.g.,FDAForm1572,NCIBiosketch,FinancialDisclosureForm,AgentShipmentForm)

• Registrationprocesschangedfrompaper-basedtoon-line

• ChangefromtwotoFIVEregistrationtypes

• Alldocumentssignedelectronically(IAMcredentials)

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FDA 1572 Guidance documentØ https://www.fda.gov/downloads/RegulatoryInformation/Guidances/UCM214282.pdf

Ø Code of Federal Regulations < 21 CFR Part 312 >

Ø Agreement between investigator and Sponsor

Ø Provide study information to Sponsor

Ø Comply with FDA regulations

Ø Provides information to evaluate qualifications of investigator (completed fields

plus BioSketch)

Ø Informs investigator of obligations and collects commitment to conduct study per

FDA regulations (attestations)

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Registration and Credential Repository• 1572

• PracticesitespulledfromRSS(“populatesites”button)• IntegrationwithOHRP(IRBs)andCLIA/CAP(Labs)databasesfor

real-timeverification• IntegrationwithCTEPCOREapplicationstocontroldownstream

access

• Biosketch• Education,training,employment• CollectsGCPandHSPtrainingcertificates• Integrationwithlicenseverificationservice

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Summary of Registration TypesRegistration Type Abb. Registration Requirements Business Rules

Investigator IVR Electronic annual registration using RCR• FDA Form 1572• Financial Disclosure Form• NCI Biosketch• Agent Shipment Form (if applicable)• Human Subjects Protection*• Good Clinical Practice*• Optional CV*

• Practice Site must be on the 1572 to be claimed on a roster

• IRB number on site registration must be on the Site - Protocol PI’s 1572

• IRB number covering the treating, consenting, credit, drug shipment, receiving (transfer to) investigator must be listed on their 1572

Non-Physician Investigator

NPIVR Electronic annual registration using RCR• FDA Form 1572• Financial Disclosure Form• NCI Biosketch• Human Subjects Protection*• Good Clinical Practice*• Optional CV*

• Practice Site must be on the 1572 to be claimed on a roster

• IRB number on site registration must be on the Site - Protocol PI’s 1572

• IRB number covering the treating, consenting, credit, receiving (transfer to) non-physician investigator must be listed on their 1572

Associate Plus AP Electronic annual registration using RCR• Financial Disclosure Form• NCI Biosketch• Human Subjects Protection*• Good Clinical Practice*• Optional CV*

• Must have an AP, NPIVR, or IVR registration type to hold the OPEN Registrar role, RAVE CRA role, TRIAD Site User role, primary site roles, or the CTMB-AIS Auditor role

• May be selected as the Consenting Person in OPEN

Associate A Electronic annual registration using IAM May access CTSU website and systems including view access to OPEN and RAVE

Associate Basic AB Electronic annual registration using IAM Cannot access CTEP, DCP, CIRB, or CTSU systems

* Upload hardcopy document

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https://ctep.cancer.gov/investigatorResources/default.htm

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RCR Challenges• GCP / HSP training documents

• “not applicable” sections – APs

• License verification

• Turnaround time for requests

• System integration

• 60 day and 30 day warning notifications - APs

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Registration and Credential Repository Demo

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QUESTIONS ???

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RCR Reference Slides

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TosetupaRegistrationCoordinator(RC):

Sendanemailto<CTEPRegHelp@ctep.nci.nih.gov >withSubject:MakeMeaRegistrationCoordinator

• IncludeCTEPPersonID,fullname,andCTEPSiteCodefortheproposedRCaswellasalistofinvestigators(withtheirCTEPPersonIDs)tobeaddedtotheRCsportfolio

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TosetupaBackupRegistrationCoordinator(BackupRC):

Sendanemailto<CTEPRegHelp@ctep.nci.nih.gov >withSubject:AddBackupRegistrationCoordinator

• IncludeCTEPPersonIDandfullnameofthecurrentRCaswellastheCTEPPersonIDandfullnameoftheproposedBackupRC

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TosetupaPrimaryShippingDesignee(PSD):

Sendanemailto<CTEPRegHelp@ctep.nci.nih.gov >withSubject:EstablishingaPrimacyShipping

Designeefor<CTEPSiteCode/CTEPSiteName>

• IncludeCTEPPersonIDandfullnamefortheproposedPSD(Note:pharmacistwithpharmacyaddressstronglypreferred)

• CTEPRegistrationTeamwillcontacttheproposedPSDtocompletea“PSDWorksheet”identifyingtheshippingCTEPSiteCode,shippingaddress,shippingcontactinformation,andorderingdesignees

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RCR: Weblinks and Help Desk § CTEPRegistrationWebsite

§ https://ctep.cancer.gov/investigatorResources/default.htm

§ CTEPIdentityandAccessManagement(IAM)

§ https://ctepcore.nci.nih.gov/iam

§ CTEPRegistrationandCredentialRepository(RCR)§ https://ctepcore.nci.nih.gov/rcr

§ RCRHelpDesk§ RCRHelpDesk@nih.gov

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Registration Documents: NCI Biosketch

HumanSubjectsProtection(HSP)Training§ RequiredonetimeforallIVRs,NPIVRs,andAPs§ https://humansubjects.nih.gov/resources

§ https://humansubjects.nih.gov/requirement-education

§ MustprovideTrainingProvider,CourseTitle,CompletionDate,andExpirationDate(ifapplicable)andmustuploadcertificate

§ IfNIHtraining,noexpirationdate;otherwise,theexpirationdatesetbycourseproviderapplies

§ Commonoptionsinclude(butarenotlimitedto):§ NIHOfficeofExtramuralResearchProtectingHumanResearchParticipants<https://phrp.nihtraining.com/users/login.php >(nocharge,noexpirationdate)

§ CollaborativeInstitutionalTrainingInitiative(CITI)BiomedicalBasic<https://about.citiprogram.org/en/series/human-subjects-research-hsr/ >and<https://about.citiprogram.org/en/course/biomedical-biomed-basic/ >(chargesapply,CITIexpirationdateapplies)

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Registration Documents: NCI Biosketch

GoodClinicalPractice(GCP)Training§ RequiredatleasteverythreeyearsforallInvestigator(IVR),Non-PhysicianInvestigator(NPIVR),andAssociatePlus(AP)registrationtypes

§ https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-148.html

§ MustprovideTrainingProvider,CourseTitle,CompletionDate,andExpirationDate(ifapplicable)andmustuploadcertificate

§ Expirationdateequalseither(1)expirationdatesetbycourseproviderOR(2)threeyearsfromcoursecompletiondate,whicheveroccursfirst

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CommonoptionsforGCPtraininginclude…§ CollaborativeInstitutionalTrainingInitiative(CITI)GCPforClinicalTrialswithInvestigationalDrugsandMedicalDevices(USFDAFocus)<https://about.citiprogram.org/en/series/good-clinical-practice-gcp/ >and<https://about.citiprogram.org/en/course/good-clinical-practice-basic-fda/ >(chargesapply,CITIcompletionandexpirationdatesapply)

§ CollaborativeInstitutionalTrainingInitiative(CITI)GCPforClinicalTrialswithInvestigationalDrugsandBiologics(ICHFocus)<https://about.citiprogram.org/en/series/good-clinical-practice-gcp/ >and<https://about.citiprogram.org/en/course/good-clinical-practice-basic-ich/ >(chargesapply,CITIcompletionandexpirationdatesapply)

§ NationalInstituteofAllergyandInfectiousDiseases(NIAID)GoodClinicalPracticescourse<https://gcplearningcenter.niaid.nih.gov/ >(freeofcharge,NIAIDcompletiondateapplies,defaultthreeyearexpirationdateapplies)

§ NationalInstituteonDrugAbuse(NIDA)GoodClinicalPracticecourse<https://gcp.nidatraining.org/ >(freeofcharge,NIDAcompletionandexpirationdatesapply)

§ Transcelerate GCPMutualRecognitionProgram<http://www.transceleratebiopharmainc.com/gcp-training-attestation/ >