Experiences in Standardizing Electronic Case Report Forms

Experiences in Standardizing Electronic Case Report Forms

Presented by: Bob Lanese, Case Comprehensive Cancer Center, Case Western Reserve University

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Fall 2013 Conference

September 18-20Omni New Haven Hotel at YaleCo-hosted by the Yale School of Medicine

Experiences in Standardizing Electronic Case Report Forms

Bob LaneseCase Comprehensive Cancer Center

Case Western Reserve University

Agenda

OverviewHistory – “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 thereCancer Related• CRF Harmonization and Standardization Project• caDSR Cancer Data Standards Repository

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

• CAP Cancer Checklists 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)

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

Use what is out there

“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

Choose CRF

Different download formats

Pick Element

The Data Element Window

Data Element Info

List of Values

How to put it together …

First a concept on Forms …

Header moduleHeader moduleStudy ID____ PI_______ Course#_____Patient ID____ Institution ID____ Pg#_____

OutcomesOutcomes

Insert Mandatory, Conditional CDEs (if applicable), select Optional CDEs as

desired.

Insert Mandatory, Conditional CDEs (if applicable), select Optional CDEs as

desired.

Staging/Extent of Disease

Staging/Extent of Disease

Disease status_____ Stage_______ TNM_____Primary Site____ Metastatic Sites____

Hypothetical Assembly of a Disease History and Prior Therapies CRF (for paper) using caBIG® standardized CRF Modules

Disease response_____Date of response assmt____

Agents (Prior/Post Therapies)

Agents (Prior/Post Therapies)

Sign Off / FooterSign Off / Footer CRC Name_____ Signature___ Date_____PI Reviewed____ Signature____ Date_____

Prior Agent Name_______ {date type} Therapy Start Date_____{date type} Therapy Stop Date____ {dose type} Total Dose____ Unit____

Insert Mandatory, Conditional CDEs (if applicable), select Optional CDEs as

desired.

Insert Mandatory, Conditional CDEs (if applicable), select Optional CDEs as

desired.

Insert Mandatory, Conditional CDEs (if applicable), select Optional CDEs as

desired.

Insert Mandatory, Conditional CDEs (if applicable), select Optional CDEs as

desired.

Insert Mandatory, Conditional CDEs (if applicable), select Optional CDEs as

desired.

Insert Mandatory, Conditional CDEs (if applicable), select Optional CDEs as

desired.

Insert Mandatory, Conditional CDEs (if applicable), select Optional CDEs as

desired.

Insert Mandatory, Conditional CDEs (if applicable), select Optional CDEs as

desired.

Disease History and Prior Therapies

Created by Lara Fournier, OHSU, March 2009

Header moduleHeader moduleStudy ID____ PI_______ Course#_____Patient ID____ Institution ID____ Date _________

Pg#_____Insert Mandatory, Conditional CDEs (if

applicable), select Optional CDEs as desired.

Insert Mandatory, Conditional CDEs (if applicable), select Optional CDEs as

desired.

Hypothetical Assembly of a Pathologic Specimens CRF (for paper) using caBIG® standardized CRF Modules

SpecimensSpecimens

Sign Off / FooterSign Off / Footer CRC Name_____ Signature___ Date_____PI Reviewed____ Signature____ Date_____

Insert Mandatory, Conditional CDEs (if applicable), select Optional CDEs as

desired.

Insert Mandatory, Conditional CDEs (if applicable), select Optional CDEs as

desired.

Insert Mandatory, Conditional CDEs (if applicable), select Optional CDEs as

desired.

Insert Mandatory, Conditional CDEs (if applicable), select Optional CDEs as

desired.

Pathologic Specimens

Created by Bob Lanese, CWRU, April 2013

Specimen # Body Site Tissue Type Result

1234A45 Colon Tumor Malignant

1234A46 Lung Tumor Metastatic

1234A47 Lung NAT Normal

1234A48 Colon NAT Unknown

SurgPath #: ______________ Case # ___________

What does the PI want versus what the PI actually needs.

We start with the basics.

Have you ever gotten something like this?

Pencil, Paperand

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

ReferencescaDSRhttps://wiki.nci.nih.gov/display/caDSR/caDSR+Content

CRF Harmonization and Standardizationhttps://wiki.nci.nih.gov/display/CRF/CRF+Harmonization+and+Standardization

To CDE Browser Pagehttps://cdebrowser.nci.nih.gov/CDEBrowser/jsp/cdeBrowse.jsp?performQuery=newSearch&PageId=DataElementsGroup

CAPhttp://www.cap.org/apps/cap.portal?_nfpb=true&cntvwrPtlt_actionOverride=%2Fportlets%2FcontentViewer%2Fshow&_windowLabel=cntvwrPtlt&cntvwrPtlt%7BactionForm.contentReference%7D=committees%2Fcancer%2Fcancer_protocols%2Fprotocols_index.html&_state=maximized&_pageLabel=cntvwr

SNOMED CThttp://www.nlm.nih.gov/research/umls/Snomed/snomed_main.html