TAB 17.00 Data Management Plans - ICSSC

1 research Informatics1 data Management Plans data Management Plans Patrick MurphyDirector of research InformaticsFamily Health InternationalDMID/ICSSCR esearch Informatics2 What is a data Management plan ?What is a data Management plan ?A written document that describes plan for collecting and managing data throughout the life of a study. Similar in nature and scope to a statistical analysis plan or a clinical monitoring Informatics3 What Information Should be What Information Should be Reviewed to Write A DM PlanReviewed to Write A DM PlanStudy ProtocolThe study protocol defines how and why the study is being conducted.

2 This document is key to understanding the Manual/Monitoring PlanCRFsData coming from external sources, , laboratory dataResearch Informatics4 Who is the Target Audience of a Who is the Target Audience of a DM plan ?DM plan ? data managersData programmersQuery staffProject LeaderClinical MonitorsStatisticiansSite staffResearch Informatics5 DMID DM plan TemplateDMID DM plan TemplateProvided in Workshop Notebook AppendixResearch Informatics6 DMID DM plan Template DMID DM plan Template ContentsContentsResearch Informatics7 DMID DM plan Template DMID DM plan Template ContentsContentsResearch Informatics8 What Information Should be What Information Should be Contained in a DM plan ?

3 (1)Contained in a DM plan ? (1)Definition of Source data /DocumentsData Capture/Case Report FormsData TransferData Entry System/ValidationData Entry/FilingData QueryingData Set CreationData Storage/ArchivingResearch Informatics9 What Information Should be What Information Should be Contained in a DM plan ? (2)Contained in a DM plan ? (2)External data ( , lab data )Protocol ViolationsSerious Adverse EventsCoding of Medical TermsDSMB and IND reportsData AssessmentsData AuditsResearch Informatics10 GCP Document FilingGCP Document FilingYesYesSignature of CRF , dated, completed of Files? Informatics11 research Informatics12 research Informatics13 research Informatics14 Flow Chart Between EntitiesFlow Chart Between EntitiesResearch Informatics15 WhiteCRFBFSY ellowPinkYellowCRFBFSW hiteRDCSRDMCW hiteCRFBFSY ellowPinkYellowCRFBFSRDCSRDMCW hiteAfter data EntryAfter data EntryBefore data EntryBefore data EntryResearch Informatics16 Yellow CRFs to RDCS after the study has been will notify SI that CRFs have been sent to their Independent PhysicianDDM, CM and Gladstone Gladstone InstituteIndependent Physician (identified by the SI)

4 FHIFHIG ladstone Institute,San Francisco, CAGRT*and PRT*White CRFs to FHI. DM Net reports to the will reports results to the , ITMNAUZ ITMITMUZ Gasthuisberg, Leuven, Belguim(ITM staff may assist)TENOW hite CRFs to , ITMNAITMITMITMITMOLAW hite CRFs to will contact Sites and FHI Clinical Study Staff with , ITMNARDCSITMITMITM, Antwerp, BelguimPCREnd of StudyQuickly Communicate Results to SitesResolve DiscrepanciesPink CRF*Yellow CRFW hite CRFCRF Entered ByCRF Completed ByLab CRFR esponsibilities by CRFR esponsibilities by CRFR esearch Informatics17 List of AppendicesList of AppendicesResearch Informatics18 Sample FormsSample Forms--Batch Flow Batch Flow SheetSheetResearch Informatics19 research Informatics20 Instructions for Detailed ProcessesInstructions for Detailed ProcessesResearch Informatics21 VersioningVersioningResearch Informatics22 Source data /DocumentsSource data /DocumentsDocument where data is first capturedDefine your source

5 DocumentsImportant for monitoringImportant for participant filesResearch Informatics23 Case Report FormsCase Report FormsA CRF can be a source document if the CRF is the initial document where data is recordedFormatted electronic data entry screens meet the definition of CRFsElectronic CRFs must meet the same requirements as paper CRFs (audit trail, conformity with source data )Electronic data Capture (EDC) has many definitionsResearch Informatics24 Electronic data Capture (EDC)Electronic data Capture (EDC) Source data captured initially into a permanent electronic record - CDISC Standards & Electronic Source data within Clinical Trials, version , page 13, 20 NOV 2006 The direct entry of clinical data into a computer database (either a PC, laptop, or other such device) during a clinical trial.

6 This may partially or wholly replace data capture in a paper CRF. - EDM forum, 2004, slide 50, France, 2004 research Informatics25 Electronic data Capture (EDC)Electronic data Capture (EDC) Information that is first recorded on paper by the investigator s staff or the patient, is subsequently entered into a computer at the investigator s site, and it delivered electronically to the sponsor or sponsor s representative (such as a CRO) without a hand-written case report form. - The eClincical Form and PhRMA EDC/eSource Taskforce The Future Vision of Electronic Health Records as eSource for Clinical research , version , September 14, 2006, page 11 research Informatics26 data TransferData TransferHow will the CRFs be transferred from the sites to the data entry office?

7 Will lab data be provided in Excel files or other data structure?Sponsor should always retain the original CRF Informatics27 data Entry System/ValidationData Entry System/ValidationWhat type of data entry system will be used?Will validation follow an SOP?Where will system be located?How will data be backed up/restored? research Informatics28 data Entry/FilingData Entry/FilingHow will you assure accurate data entry?If double data entry used, how will discrepancies be resolved?Double data entry requirementsDescribe filing systems at sites and data Management centers Identify equipment that needs to be purchasedResearch Informatics29 Filing SystemFiling SystemResearch Informatics30 data QueryingData QueryingWill your data be systematically cleaned?

8 How will you document changes to your CRFs?How will you document changes to your database?Coordinate schedule with monitoring visits, DSMB reports, interim analyses, study closeout research Informatics31 data Storage/ArchivingData Storage/ArchivingWhere will CRFs be stored during and after the study?How will data sets be created/controlled during and after study?Original documents should be stored in a secure (locked) room or file procedures for granting access to database controlsUsername/PasswordsIt is important that the data and audit trail are easily accessible for Informatics32 When Should a DM plan be When Should a DM plan be Updated?

9 Updated?When the Protocol is amendedAddition or removal of a siteNew CRF added to the studyWhen data handling process changesYearly review by data manager; only need sign-off if major changes have occurredResearch Informatics33 data plan ConclusionsData plan ConclusionsA data Management plan helps define the process and document your proceduresHave SOPs and WIs to support the DM PlanReview the study protocolCommunicate with the study teamCreate Flowchart of data , Forms, and Lab Samples Page 1 of 1 21 JAN 2010 Breakout Session Create a flowchart for data Management for the following study. On the flowchart, indicate the following: data Management center, sites, and labs Filing of different plies of CRFs Flow of different plies of CRFs Forms used to track CRFs, lab samples Flow of lab samples and results Please use different color pens to help make your flowchart more understandable.

10 Please leave extra space because we will use this flowchart in another breakout session. Example Study Description data will be collected on 2-ply CRFs at 4 sites within a country. One of the sites will also serve as the data Management center (DMC). Each participant will have blood samples drawn and sent to one central lab. Lab results should be sent to the site and to the DMC. CRFs should be filed at the DMC and at the sites. Lab results will be used for participant care.