Experiences in Standardizing Electronic Case Report Forms
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Experiences in Standardizing Electronic Case Report Forms

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Originally recorded by Forte Research Systems (http://info.forteresearch.com/standardizing-ecrfs) on Aug 13, 2013. Presented by Bob Lanese of Case Comprehensive Cancer Center, Case Western University ...

Originally recorded by Forte Research Systems (http://info.forteresearch.com/standardizing-ecrfs) on Aug 13, 2013. Presented by Bob Lanese of Case Comprehensive Cancer Center, Case Western University (http://cancer.case.edu/researchadmin/).

Building a standard library of electronic Case Report Forms (eCRFs) can be very beneficial for institutions. It can save staff the time associated with creating new forms for each study, and ensure the right data is collected.

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  • Note: Field/CDE in bracket e.g. {date type} are hidden on CRFBold fields are mandatoryValid values for certain fields may inserted into form itself or included in separate CRF instructions.
  • Note: Field/CDE in bracket e.g. {date type} are hidden on CRFBold fields are mandatoryValid values for certain fields may inserted into form itself or included in separate CRF instructions.

Experiences in Standardizing Electronic Case Report Forms Experiences in Standardizing Electronic Case Report Forms Presentation Transcript

  • Experiences in Standardizing Electronic Case Report Forms Presented by: Bob Lanese, Case Comprehensive Cancer Center, Case Western Reserve University Webinar ID: 820879968 Audio Dial-in: 1.888.824.5783 Access Code: 54875701 Please note that all participant phone lines are muted. Please use the chat box for any questions. Hosted by
  • Comprehensive software including CTMS, EDC, billing compliance and more for the academic research enterprise Simple, powerful, and affordable electronic data capture software for academic researchers. Fall 2013 Conference September 18-20 Omni New Haven Hotel at Yale Co-hosted by the Yale School of Medicine
  • Experiences in Standardizing Electronic Case Report Forms Bob Lanese Case Comprehensive Cancer Center Case Western Reserve University
  • Agenda  Overview  History – “In hindsight …”  Planning – “We didn’t know you wanted to capture that”  Roles and Workflows – “The concept of duality”  Keeping the Balance – “Needs vs. Wants”  Standardization – “Apples and Oranges”  Questions
  • Overview Discussion will be top down… That is it will discuss the overall roles, process, and workflow associated with capturing Clinical and Research Data in a Clinical Trials environment, then go into the specifics associated with developing eCRFs for data capture. One caveat – I’ll only be discussing what I know including only Cancer-related clinical trials, although the concepts can be used across the board.
  • History … In Hindsight • OnCore “live” date was June, 2004. • Used and sometimes modified the built-in Theradex forms as a start. • Tried many different workflow scenarios to build forms and develop calendars.  Roles: OnCore Admin and a Research Nurse  Workflow: Many iterations, no plan from research perspective  No “Best Practice” • Creation and Modification of Forms in OnCore was a challenge that was not well understood.
  • Develop a plan – “In the beginning …” God • • • • • • • Need to Ask the question: “Why are we doing this?” Define a set of criteria for every trial. Define roles of who does what. Define a workflow of who, what, when where, and how. Be consistent. Study calendar in the protocol should be robust and consistent. Revisit these at appropriate intervals or when problems occur.
  • At CWRU … The chief purpose to collect data is to support the Principal Investigator for evaluating Primary and Secondary Outcomes associated with a particular study. Ancillary reasons include governmental reporting, quality assurance, safety and efficacy in all required areas of the Clinical Trials Unit. In other words we support: • The PI • Data Safety and Monitory • Quality Assurance • NCI, CTRP, and clincaltrials.gov
  • At CWRU … • Data collection is done for every trial  Financial data is collected for Cooperative and Industry Trials  Financial and Research data is collected for Investigator-Initiated Trials
  • Roles and Workflows – “The concept of duality” Roles • Case CCC University Hospitals has two different roles that are used  Financial Calendar Builder (FCM)  Data Manager (DM)  Both work together  These roles do not develop eCRFs Workflow • FCM starts putting together the financial events of the calendar as soon it is received, usually after PRMC approval. Events driven and no eCRFs • DM manager fills in the data events and the associated eCRFs. • Data Management meeting scheduled to discuss Calendar and eCRFs before release. Circular.
  • eCRF Development We’ll look at these points in more detail • • • • • • • • Take a few breaths and think about it before you react to anything Strive to develop a standard set of eCRFs Use what is out there Needs vs. Wants Pencil and Paper Develop in Excel, then Word, then OnCore Think about developing your own data dictionary Structure and Guides
  • Take a few breaths and think about it before you react to anything If I were King, this would be one of my official decrees, the World would be a much better place. However, since I am not, these are things I think about…. … in most cases this does present a challenge, but I think how to turn something specific into something that accomplishes the same thing but is general in nature that can be used over again in some other study … … I am smart enough to know that I am not the first person that this has been presented to, so I go look for examples … … bounce ideas off others …
  • Strive to develop a standard set of eCRFs • Case CCC use the same eCRFs for about 90%+ for protocols • Adverse Events • Study Drug Administration • Tumor Assessment (Recist Target, Recist Non-target and Non-recist) • Course Assessment • Concomitant Medications • Vital Signs • Physical Exam • Treatment • Radiation Treatment • Cycle Assessment • Prior Treatments, Surgery, Radiation
  • Use what is out there Cancer Related • CRF Harmonization and Standardization Project • caDSR Cancer Data Standards Repository    • CAP Cancer Checklists  • Use the CDE Browser caDSR Contexts>>caBIG (NCI cancer Biomedical Informatics Grid)>>Classifications>>Data Standards>>Standard CRFs> The caDSR is a good resource for finding Form elements and associated Domains Pathology and Diagnosis Bio-Behavioural Measures  PROMIS, NCI, … All Disease • Snomed Clinical Terms (CT)  • the most comprehensive, multilingual clinical healthcare terminology in the world. International Classification of Diseases (ICD)
  • Use what is out there Background CTWG Vision Statement Enhance the best of all the components of the NCI- supported clinical trials system to develop a cooperative enterprise built on a strong scientific infrastructure and a broadly engaged coalition of critical stakeholders
  • “Establish Core Library of Standardized Case Report Forms (CRFs) through Stakeholder Consensus”
  • eCRFs and Data Elements • The eCRF is a vehicle for collecting information pertaining to patient events, procedures, results, outcomes, etc… • It is usually categorical in nature to make things a bit easier to manage and relate like things together based on the type of category chosen.   Vital Signs Physical Exam • The parts that define the eCRF are the Data Elements and Domains. Let’s talk about Data Elements and where to find them……
  • The CDE Browser of the caDSR Different download formats Choose CRF Pick Element
  • The Data Element Window List of Values Data Element Info
  • How to put it together … First a concept on Forms …
  • Hypothetical Assembly of a Disease History and Prior Therapies CRF (for paper) using caBIG® standardized CRF Modules Header module Insert Mandatory, Conditional CDEs (if applicable), select Optional CDEs as desired. Study ID____ Patient ID____ PI_______ Course#_____ Institution ID____ Pg#_____ Disease History and Prior Therapies Staging/Extent of Disease Agents (Prior/Post Therapies) Insert Mandatory, Conditional CDEs (if applicable), select Optional CDEs as desired. Disease status_____ TNM_____ Primary Site____ Metastatic Sites____ Stage_______ Insert Mandatory, Conditional CDEs (if applicable), select Optional CDEs as desired. Prior Agent Name_______ {date type} Therapy Start Date_____ {date type} Therapy Stop Date____ {dose type} Total Dose____ Unit____ Outcomes Insert Mandatory, Conditional CDEs (if applicable), select Optional CDEs as desired. Disease response_____Date of response assmt____ Sign Off / Footer Insert Mandatory, Conditional CDEs (if applicable), select Optional CDEs as desired. CRC Name_____ Signature___ PI Reviewed____ Signature____ Date_____ Date_____ Created by Lara Fournier, OHSU, March 2009
  • Hypothetical Assembly of a Pathologic Specimens CRF (for paper) using caBIG® standardized CRF Modules Header module Insert Mandatory, Conditional CDEs (if applicable), select Optional CDEs as desired. Study ID____ Patient ID____ PI_______ Course#_____ Institution ID____ Date _________ Pg#_____ Pathologic Specimens SurgPath #: ______________ Case # ___________ Specimen # Insert Mandatory, Conditional CDEs (if applicable), select Optional CDEs as desired. Colon Tumor Malignant 1234A46 Lung Tumor Metastatic Lung NAT Normal 1234A48 Sign Off / Footer Result 1234A47 Specimens Tissue Type 1234A45 Insert Mandatory, Conditional CDEs (if applicable), select Optional CDEs as desired. Body Site Colon NAT Unknown CRC Name_____ Signature___ PI Reviewed____ Signature____ Date_____ Date_____ Created by Bob Lanese, CWRU, April 2013
  • What does the PI want versus what the PI actually needs. We start with the basics. Have you ever gotten something like this? Pencil, Paper and THINK!
  • This takes a different approach, almost philosophical… from Specific to General… Put some concepts and designs down on paper, remember, think what the PI needs and what Others may need going forward.
  • Organize it using Excel…
  • Including Domains
  • Then Develop the Form using Word …
  • Can also be very involved like this … a Renal Biopsy Form
  • Also Added Constraints
  • Finished Form in OnCore complete with Domains and Constraints.
  • Why do I go through all this pain … • Because in this life I haven’t suffered enough • The Excel workbook is the source for your data dictionary. Is useful for:  Building a Data Dictionary database  Can contain sources for Elements and Domains • The Word document is the eCRF guide for that particular CRF and acts as a paper backup as well. Can contain:  The Form  Domains  Constraints  Directions • Both an eCRF Guide and a Data Dictionary are extremely useful
  • References caDSR https://wiki.nci.nih.gov/display/caDSR/caDSR+Content CRF Harmonization and Standardization https://wiki.nci.nih.gov/display/CRF/CRF+Harmonization+and+Standardization To CDE Browser Page https://cdebrowser.nci.nih.gov/CDEBrowser/jsp/cdeBrowse.jsp?performQuery=newSearch&PageId=DataE lementsGroup CAP http://www.cap.org/apps/cap.portal?_nfpb=true&cntvwrPtlt_actionOverride=%2Fportlets%2FcontentViewer%2Fsh ow&_windowLabel=cntvwrPtlt&cntvwrPtlt%7BactionForm.contentReference%7D=committees%2Fcancer%2Fcancer _protocols%2Fprotocols_index.html&_state=maximized&_pageLabel=cntvwr SNOMED CT http://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html