CMCVellore

AIChecklist

V6.0

SNo

Queriestobeaddressed

Clarification

Response

1

Whatisthegoaloftheengagement?

Whatareaims/overarchinggoalsofthisproposedresearch/project?

Research&development(needIRB)

Doestheproposedresearch/projectinvolveresearch&development?

(IRBapprovalisrequired)

TestingandvalidationinIndianpopulation(needIRB)

DoestheproposedincludetestingandvalidationinIndianpopulation?

(IRBapprovalisrequired)

EvaluationtowardsPurchase(usualpermissions)

Doestheproposedincludeevaluationtowardspurchase?

(usualpermissionsforpurchasearerequired)

2

Whatis/aretheexpectedoutcome(s)?

Whatis/aretheexpectedoutcome(s)oftheproposedresearch/project?

3

Timeperiodfortheproject/engagement

Whatisthetimeperiodfortheproposedresearch/project?

4

Consentfrompatient(whatallshouldbecovered?)

Consentformshouldincludespecificclausetocoverthis

ResearchInvolvinghumanparticipantsDoesyourproposalincludeworkingwithhumanparticipants,experimentswithhumanstemcells,biologicalsamplesand/orpersonaldatarelatingtolivingordeadpersons?

Ifyes,pleasestate:iftheprojectwas/willbereviewedbyIRB?Alsospecifyanyotherregulatoryapprovalsthathavebeen/willbeobtainedfromparticipatinginstitutions/collaborators.

DatastorageandsharingWhereappropriate,detailyourplansfordatamanagement,curationandstorage.

Whereappropriate,detailyourpolicyforsharingdatawithothers,includingwithininstitutionandprioritisationofaccesstodata

Datatobeshared

Ifdataisshared,givedetailsonhowwillitbeshared.

Datamovedoffsite

WoulddatabestoredoutsidetheCMC?E.g.cloudstorage,partnerinstitutionsiteetc

UsedinAIdevelopment/validation

5

IsthereanMOUthatneedstobesigned?

Collaborativeengagement

Istheproposedresearch/project,inwholeorinpart,subjecttoanyagreementswithcommercial,academicorotherorganisationsthatrequiresanMOU?

IfYes,Haveyousubmittedforlegalreview?

6

Isthereanon-disclosureagreement(NDA)tobesigned

Wouldtheproposedresearch/projectrequireyoutosignanon-disclosureagreement(NDA)?

IfYes,Haveyousubmittedforlegalreview?

7

Whatarethebenefitsoftheprojectfor

Whatarethebenefitsoftheprojecttowardsthefollowing?

Patientcare

Patientcare

Department

Department

Institution

Institution

8

WillCMCbepermittedtopublishtheresults?(scientificjournal)

IntellectualProperty

AreyouawareofanypotentialsituationwhereyouorCMCwillnotbepermittedtopublishthefindingsofthisstudy?(e.gconferenceorscientificjournal)

9

Copyrightco-ownershipforcommercialuseifcollaboratingwithcommercialentity

Areyouawareofanycopyrightco-ownershipforcommercialuse,ifcollaboratingwithcommercialentity?

Willtheproposedresearch/projectusetechnology,materialsorotherinventionthat,asfarasyouareaware,aresubjecttoanypatentsorotherformofintellectualpropertyprotection?

10

IstherenewIPthatwillresultfromthisproject?(Ifyes,pleaseseeCMCIPpolicy)

Istheproposedresearch/projectlikelytoleadtoanypatentableorcommerciallyexploitableresults?(Ifyes,pleaseseeCMCintellectualpropertyprotectionpolicy)

11

Timecommitment(datacollection,verification,validationetc)

Timecommitments

WhatarethetimecommitmentrequiredfromCMCcollaboratorstowardsdatacollection,verification,validationetc.?

Dataentryoperator

Dataentryoperator

Resident

Resident

Consultant

Consultant

12

Whatarethesourcesoffundingforthisproject?

FundingandResourceutilization

Whatarethesourcesoffundingforthisproposedresearch/project?

13

Anynewhardwareorsoftwaretobepurchasedfortheproject?IncludeOS,softwareapplication,internetaccessandmailserviceifrequired.

Wouldtheproposedresearch/projectrequirenewhardwareorsoftwarethatneedtobepurchased?MentiontherequirementsincludingOS,softwareapplication,internetaccessandmailservice,ifrequired.

(AquotationisrequiredforanyequipmentcostingoverINR50Lakhs)

Areyouawareofexistinghardwareorsoftwareavailablewithintheinstitutionthatcouldbebeneficialforyourproject?

14

Whowillfundthehardware/softwareacquisition,dataextraction?Relatedto#9,16

Whowillfundthehardware/softwareacquisition,dataextractionetc?Relatedto#13,16

15

Whatwillhappentothehardwareaftertheproject?

Whatwillhappentothehardwareoncetheproposedresearch/projectiscompleted?

16

Personnelcommitment

Personnelcommitment

Whowilldothedataentry

Haspersonnelbeendedicatedfordataentry?Ifyes,identifytheperson.

WhowillreceivetheresultsofAIanalysis

HaspersonnelbeenidentifiedtoreceivetheresultsofAIanalysis??Ifyes,identifytheperson.

Doesithappenimmediatelyorisitasynchronous?

Movedlower

AIinfrastructureandanalysis

WouldthedatabeusedforAIbaseddevelopment/validation?

17

WherewilltheAIbeimplemented(“running”)?

IfYes,WherewilltheAIalgorithmbe“running”?

Onaserveron-premisesinCMC

Onaserveron-premisesinCMC

Ontheinternet(publiccloudorontheirserver)

Ontheinternet(publiccloudoronpartnerinstitutionserveretc.)

WilltheresultsoftheAIanalysisbesharedwiththeidentifiedpersonnelimmediatelyorisitasynchronous?

18

WhatisrequiredfromCMC

Datarequirementsandusage

WhatisthenatureofdatarequirementfromCMC?

LimitedsetofPatientData(retrospective)

LimitedsetofpatientData(retrospective)

Limiteddataset(prospective)

Limiteddataset(prospective)

Livepatientdata(realtime?)

Livepatientdata(real-time)

19

Formatofdata

Inwhatformatwouldthedatabeusedfortheproposedresearch/project?

Identified

Identified

De-identified

De-identifiedorPseudonymised(pseudonymisationdoesnotremoveallidentifyinginformationfromthedatabut

merelyreducesthelinkabilityofadatasetwiththeoriginalidentity

ofanindividual)

Anonymised

Anonymised

(Withanonymisation,thedataisscrubbedforanyinformationthatmayserveasanidentifierofadatasubject,institutionetc)

20

Whowillensuredataquality&format(19)

Haspersonnelbeenidentifiedtoensuredataquality&format(19).Ifyes,identifytheperson

21

WillCMCgetusagerightstoalgorithms/workflows/software/productsdevelopedwiththisproject-anyconditions?

Haveyoudiscussedtheusagerightstoalgorithms/workflows/software/productsdevelopedwiththisproposedresearch/project.AreyouawareofanyconditionsthatlimitsCMCfromusingtheabove?

22

Howwillthedatabetransferredtothem?

Howwillthedatabetransferredtothem?

Manualentry

Manualentry

DataextractfromCMCHIS(mayrequireseparatepermissions)

DataextractedfromCMCHIS(additionalpermissionsmayberequired)

InterfacefromtheHIS(mayrequireseparatepermissions)

InterfacefromtheHIS(additionalpermissionsmayberequired)

23

Aftertheperiodofengagement,willCMCdata

Aftertheperiodofengagement,areyouawareofhowtheCMCdatawillbeused?

besharedwiththirdparties

Sharedwiththirdpart