2015 TMF Survey Overview - TMF Reference Model
TMF Reference ModelTopline results of2015 TMF Survey #5September 2015Fran RossTMF Survey Sub-team
Trial Master File (TMF) Survey Background TMF Survey purpose: industry-wide, gather insight into quality, costand effectiveness drivers of TMF management, including:– Knowledge and use of TMF Reference Model– TMF management pain points– Paper vs electronic TMF Data for the 2015 was collected from May to July 2015 This TMF Survey has been conducted as an initiative of the TMFReference Model (TMF RM) and is performed annually. The TMFRM committee and leadership operate in coordination with the EDMReference Model as initiatives of the Document and RecordsManagement (DRM) Community in the DIA2
Report Sections Respondent DemographicsTMF / eTMF InsightsTMF MetricsTMF Reference Model UseInspection Trendselectronic Investigator Site File (eISF)2015 TMF Survey3
RESPONDENT DEMOGRAPHICS4
Respondent Organization Type 159 Evaluable ResponsesSponsor organizations majority respondents (53%)Your organization type:6%Sponsor14%SiteCRO9%53%ConsultantVendorOther (please specify)17%1%2015 TMF Survey5
Respondent LocationWhere are you located?1%13%Asia PacificEurope29%57%USA / CanadaAfrica2015 TMF Survey6
Trial Outsourcing ProfileWhat percentage of current Phase II/III trials are fullyoutsourced to CROs? (select closest percentage)22%26%100% fully out-sourced76-99%51-75%26-50%17%20%0-25%15%2015 TMF Survey7
Active TrialsIndicate the number of active trials at your organization11%12%1 to 45 to 2521%28%26 to 5051 to 100101 to 500501 to 100012%16%2015 TMF Survey8
TMF / eTMF INSIGHTS9
TMF SOP Adherence2%Does your organization have and follow a TMF SOP?0%6%3%Yes, followed consistentlyYes, followed inconsistentlyYes, not followed28%No, in development61%2015 TMF SurveyNo, no plans for SOPNot required10
Paper or ElectronicWhat format is your file of record?3%All Inspectable TMF / ISF inpaper29%All Inspectable eTMF / eISFCombination paper andelectronicOther57%11%2015 TMF Survey11
Numbers of unique artifactsHow many record types in the index / table of contents?8%4%29%Less than 200201-40018%401-600601-800801 41%2015 TMF Survey12
Documents requiring signatureHow many unique content types must be signed?6%15%Less than 1012%11-2526-5014%50-7532%76-100101 21%2015 TMF Survey13
eTMF StatusWhat is the status of your organization's eTMF?7%We currently use eTMF / eISF18%Evaluating44%Actively PlanningActively Building/Implementing17%Not Considering14%2015 TMF Survey14
eTMF DurationHow long has your eTMF been in production?17%12%4%Less than 1 Year1 Year2-3 Years21%4-5 years6 or more years46%2015 TMF Survey15
More Than One System?Do you use more than one system?22%NoYes - we have multiple20%58%Yes - ours and our CRO's2015 TMF Survey16
Issues When Using More Than One eTMF SystemWhich of the following do you encounter when using more than onesystem? (select all that apply)1614121086420NoneIncreasedDifficultyeffort forestablishingreconcilation file of recordUserIncreased cost processing2015 TMF SurveyOthernegativeimpacts17
eTMF Archive ProcessWhat is the eTMF post-trial "archive" process"?0%6%8%25%19%No archive process, remains insystemElectronic archive, remains insystemElectronic archive, moved toanother systemStored on external mediaPrinted hard copyOther42%2015 TMF Survey18
Paper retentionDo you retain scanned paper?4%Yes, we retain all paper46%Yes, we retain some paper50%No, we do not retain any paper2015 TMF Survey19
Reasons for retaining scanned paperWhy do you retain scanned paper?302520151050Ink signeddocuments onlyIn case ofinspectionCompany policy / Because its saferSOPsand easierRequired bySponsor (CRO)202015 TMF Survey
TMF METRICS21
TMF Metrics ProgramDo you have a TMF metrics program in place?18%28%YesEvaluating15%ImplementingNot planning39%2015 TMF Survey22
TMF Metrics Program MeasurementsWhat do you measure in your TMF Metrics Program?(select all that apply)5443322110Completenessof TMFIndexingQualityMetadataQualityImage Quality System usage2015 TMF SurveyTimelinessDocumentvolume23
TMF Metrics - CostDo you measure TMF costs?38%YesNo62%2015 TMF Survey24
TMF Metrics – Cost Efficiency OpinionDo you believe your TMF is cost efficient?8%10%Very cost efficient22%29%SomewhatNeutralSomewhat inefficientVery inefficient31%2015 TMF Survey25
TMF Metrics – Risk Based MonitoringAre eTMF metrics used in your RBM program?5%28%YesIn the future43%NoNo RBM program24%2015 TMF Survey26
TMF REFERENCE MODEL USE27
TMF Reference Model AwarenessAre you aware of the TMF Reference Model?4%YesNo96%2015 TMF Survey28
TMF Reference Model UseIs your organization using the TMF Reference Model?Yes2%12%No15%Don't Know71%Not Applicable (Vendor,Health Authority,Consultant, Other)2015 TMF Survey29
Applying the TMF Reference ModelMy organization is using the Model for.14%54%Paper TMFs onlyeTMFs only32%Both paper andeTMFs2015 TMF Survey30
TMF Reference Model Use in New and Ongoing TrialsMy organization is using the Model in. (select all that apply)1009080706050403020100New TMFsOngoing,restructured TMFOngoing,documentsadded / removed2015 TMF SurveyClosed TMFsOther31
TMF Reference Model Adoption PracticesHas your organization adopted the Model as is, withoutany change?35%Yes, adopted as isNo, adapted with changes65%2015 TMF Survey32
TMF Reference Model Adoption MethodsIn adopting the Model, my organization is (select all that apply)454035302520151050Adding artifactsCondensingartifactsBranchingartifacts intosub-artifactsChanging the Restructuring Other changesRM numberingthe zonessystem2015 TMF Survey33
Changes from Adopting TMF Reference Model80706050403020100Updating/planningto change SOPsCreating/updatingMapping TMFguidance or best structure to modelpractice documents2015 TMF SurveyChanging activeTMFs to reflectmodelOther (pleasespecify)34
INSPECTION TRENDS35
Inspection HistoryHave you had regulatory agency / health authority inspections of youreTMF? (select all that apply)252015102015 TMF SurveyOtherChina - SFDABrazil - ANVISAAustralia/NewZealand - ANZTPAJapan - PMDAUK - MHRAEU - EMAUS - FDA0No536
Remote Inspection HistoryHave you yet had a remote (off-premise) inspection byany regulatory agency / health authority?21%25%YesNoUnknown54%2015 TMF Survey37
Sponsor Inspection History Paper RequestsHas any inspector refused to use eTMF and requiredpaper print out of TMF?2520151052015 TMF SurveyOther (pleasespecify)Japan - PMDAUK - MHRAEU - EMAUS - FDANo038
Sponsor Inspection History eTMF ResistanceHas any inspector refused to use paper and requiredaccess to eTMF?201612840No refusalEU - EMA2015 TMF SurveyUK - MHRAOther (pleasespecify)39
Sponsor Opinion - Inspection Preparation ImpactHas the eTMF helped ease burdens of audits /inspections?25%YesNo75%2015 TMF Survey40
Sponsor Opinion - eTMF Inspection ImpactHave auditors or inspectors found the eTMF easier toinspect using your eTMF software?16%YesNo26%58%2015 TMF SurveyWe do not allow inspectordirect access to the eTMF41
Sponsor Opinion – eTMF Impact Unannounced InspectionsHas the eTMF proved a benefit in allowing you tosupport unannounced inspections?32%YesNo57%Unknown11%2015 TMF Survey42
ELECTRONIC INVESTIGATOR SITEFILE (e-ISF)43
eTMF ExternalizationDoes your eTMF externalize content to clinical trial sites(e.g. Investigator Portal)?We currently externalizecontent8%21%Evaluating25%Actively PlanningActivelyBuilding/Implementing24%Not Considering17%Not Applicable / Unknown5%2015 TMF Survey44
eISF UsageAre electronic Investigator Site Files (eISF) being used inyour trials?26%YesNo74%2015 TMF Survey45
Percentage of Trials with eISFWhat percent of your trials have an electronicInvestigator Site File (eISF)?26%35%0-25%26-50%51-75%76-100%16%23%2015 TMF Survey46
eISF Excluded ContentWhich of the following documents, if any, are NOT stored in the eISF(select all that apply)2520151050Subject Informed Signed Financial Signed ContractsUnblindedPayment/Finance Other ExcludedConsentDisclosuresSubject ID LogDocumentsContent2015 TMF Survey47
eISF Archive ProcessWhat is the eISF post trial "archive" process?6%7%No archive, remains in system16%Electronic archive, remains insystem10%Electronic archive, moved toanother systemStored on external media29%Printed hard copy32%Other2015 TMF Survey48
eISF Technology ControlIs the eISF the site's technology or sponsor / CRO'stechnology?13%16%SiteSponsor / CROOther71%2015 TMF Survey49
2015 TMF SurveyOther (please specify)Not consideredFinancial barriersSite refusalLocal country concernsLegal cal ConstraintsBarriers to eISF uptakeIf no eISF, why not? (choose all that apply)403530252015105050
TMF Reference Model – Participate!To join the TMF Ref Model, register on the website:http://tmfrefmodel.com/Visit the website for up to date information too!Join Linked Ingroup “TMF Reference Model”http://www.linkedin.com/groups?home &gid 2663204&trk anet ug hm512015 TMF Survey
TMF 2015 Survey Team – THANK YOU! Shah AshrafAndrew MitchellPenny JegedeBetsy FallenSholeh EhdaivandSteve Scribner522015 TMF Survey
TMF Reference Model Adoption Methods 0 5 10 15 20 25 30 35 40 45 Adding artifacts Condensing artifacts Branching artifacts into sub-artifacts Changing the RM numbering system Restructuring the zones Other changes . 2015 TMF Survey Overview Created Date: 10/15/2015 1:30:39 AM .
TMF Reference Model Deliverable Page 4 of 22 16-Mar-2018 1 Introduction to the TMF Reference Model 1.1 Goal of TMF Reference Model The Trial Master File (TMF) is the trial sponsor's and investigator's collection of records (artifacts) that allows the reconstruction of the trial. It is part of the evidence for regulatory
The TMF Reference Model group strongly recommends a “file-as-you-go” strategy to ensure that the TMF is continuously up -to-date and inspection ready at all times. Where this is not in place or not possible, organizations should nonetheless define in the TMF Plan the location of relevant
Nov 18, 2020 · Trial Master File Reference Model User Guide Version 2 TMF Reference Model Deliverable Page 4 of 25 18 Nov 2020 1 Introduction to the TMF Reference Model 1.1 Goal of TMF Reference Model The Trial Master File (TMF) is the trial sponsor’s and investigator’s collection of records
The DIA TMF Reference model had been implemented (although with modifications) via a table of contents for each trial to identify the location of TMF essential documents in defined sections, however the structure of the actual TMF electronic folders had not been changed to reflect the model.
The Trial Master File Reference Model (TMF RM) User Guide provides a framework for implementing the TMF RM in your organization. The information presented in this guide was created by industry volunteers responsible for designing, implementing, managing, maintaining, evolving, and otherwise working with Trial Master Files and the TMF RM.
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