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Bill Elgie Director of IT NRG – Buffalo Office GOG Statistical & Data Management Center Roswell Park Cancer Institute Buffalo, New York.

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Presentation on theme: "Bill Elgie Director of IT NRG – Buffalo Office GOG Statistical & Data Management Center Roswell Park Cancer Institute Buffalo, New York."— Presentation transcript:

1 Bill Elgie Director of IT NRG – Buffalo Office GOG Statistical & Data Management Center Roswell Park Cancer Institute Buffalo, New York

2  Background  Legacy Data Entry System  eCRF Standardization and RAVE  Using CDE Browser  RAVE folders, forms and fields  Mapping Solution  One to One, many to one and across folders  PDF Creation and population with RAVE data

3  Roswell Park Cancer Institute  Gynecologic Oncology Group (GOG)  2000 – present  NRG Oncology  2014 – present  Frontier Science Research & Technology Foundation  1984 – 2000  AACTG (Adult Aids Cooperative Group)  PACTG (Pediatric Aids Cooperative Group)  CALGB (Cancer & Leukemia Group B)  LUDWIG, INTERG

4  The Gynecologic Oncology Group (GOG) organized in  as a non-profit international organization with the purpose of promoting excellence in the quality and integrity of clinical and basic scientific research in the field of Gynecologic malignancies.  Since 1970 the 11 original member institutions grew to over 75 principal centers and over 200 affiliate institutions.  Approximately 45 individual clinical trials were active at any one time for patients with a variety of gynecologic malignancies.  Over 3,300 patients were registered each year to GOG trials.  GOG completed well over 300 clinical trials and contributed over 550 manuscripts to peer reviewed medical literature.

5  NRG Oncology brings together the unique and complementary research areas of the  National Surgical Adjuvant Breast and Bowel Project (NSABP),  Radiation Therapy Oncology Group (RTOG)  Gynecologic Oncology Group (GOG).  NRG Oncology builds upon our more than 150 years of cumulative research experience to conduct practice defining, multi-institutional clinical trials resulting in the improved survival and quality of life of patients with cancer.

6  Background  Legacy Data Entry System  eCRF Standardization and RAVE  Using CDE Browser  RAVE folders, forms and fields  Mapping Solution  One to One, many to one and across folders  PDF Creation and population with RAVE data

7  Cardiff Software TELEForms  TELEForm PDF Designer  Internet Server

8  ActivePDF’s PDFToolkit

9  Relational Database Management System  Microsoft and Actian (Computer Associates)  SQL Server  Ingres RDBMS  Permissions  Username/password challenge, CTEP-IAM accounts  User mapped to specific patients based on institution  Role based permissions  Electronic Audit Trail  All transactions are logged  Staging table holds all submissions  All submitted transactions have a corresponding image file

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11 Color coded patient calendar Patient Initiated from Registration System Forms Due/Received Dates Hyperlinks to Forms Images, Instructions, Uploads,..

12 Pre-loaded with dates and user names Pre-loaded drug names by protocol Range checks for valid values and data checks

13  Background  Legacy Data Entry System  eCRF Standardization and RAVE  Using CDE Browser  RAVE folders, forms and fields  Mapping Solution  One to One, many to one and across folders  PDF Creation and population with RAVE data

14 https://wiki.nci.nih.gov/download/attachments/ /CRF_Harmonization_Process.jpg?version=1&modificationDate=

15 Round 1: Demography Round 2: - Adverse Events Enrollment Participant Identifier Protocol Deviation Registration Medical History Physical Examination Round 3: Study Agent/Compliance Pre/Post Treatment Agents Concomitant Agents Lab Tests/Results Staging/Extent of Disease Header/Footer/End of Form Round 4: Consent, Eligibility Criteria, Screening Surgery Radiation Therapy Diagnosis/Pathology – Administrative and Intervention Equipment Off Treatment/Off Study PET/Imaging (5 modules) Round 5: Diagnosis/Pathology – completion of Round 4 work Procedures/Procedure Results Response/RECIST Imaging Transmission, Acquisition, and Results Survival, Death, Follow-up

16  Implement across all groups  Little standardization across LPOs in regards to  caDSR content and usage  Data capture processes  Data cleaning processes  LPO implementation of Medidata Rave®  Continued use of LPO specific content  non-caDSR content  Mixed with caDSR content

17  The National Cancer Institute (NCI) Cancer Therapy and Evaluation Program (CTEP) purchased licensing rights from Medidata Solutions (Medidata) to use and distribute Medidata Rave®, to facilitate the conduct of clinical research throughout the NCI- supported clinical research enterprise.  NCI CTEP identified the Cancer Trials Support Unit (CTSU) as the CDMS Cancer Support Center (CSC) to coordinate this endeavor.  The CTSU established several CSC CDMS Working Groups to solidify requirements, processes and standards: CDMS Working Groups Data ElementsRave Mentorship Data QualityRave Validation DCP Rave AdoptionStudy Build IntegrationsStudy Conduct LeadershipUser Administration MetricsWorking Group Leaders

18  The Data Elements Working Group (DEWG):  Provide recommendations to facilitate CDMS study startup activities as related to the caDSR.  Charged with the identification and resolution of barriers to implementation.  The Study Build Working Group (SBWG):  Define a standard workflow for building studies in Medidata Rave® and develop a standard approach for configuring studies, forms, edit checks, validations, and data loads.  The Study Conduct Working Group (SCWG):  Identify processes across groups which will benefit from standardization resulting in improved clinical trial efficiency while maintaining trial integrity. Working Groups

19 1. Modify the caDSR Database structure 2. Modify the Medidata RAVE Software 3. Come up with a LPO solution

20  The amount of effort required is too great.  The data that exists is used by other entities other than the LPOs that would be adversely impacted.  The funding for this effort does not exist.

21  Simply not feasible  Medidata’s existing customer base  Not within the contract

22  LPOs identified two options :  Use only the NCI eCRF standard module content in Rave, and then convert the data into local codes/permissible values outside of Rave, OR  Capture local codes/permissible values in Rave:  Provided that the standard caDSR values are captured in Rave “as is”.  Either standard values or local values may be “derived”, provided both are captured and stored in Rave.  Data reported back to CTEP will be in the form of standard caDSR values. 22

23  Take the current caDSR structure +  Functionality that exists in RAVE +  LPO data within the data dictionaries +  NCI data within the data dictionaries +  LPO designed custom functions

24  Background  Legacy Data Entry System  eCRF Standardization and RAVE  Using CDE Browser  RAVE folders, forms and fields  Mapping Solution  One to One, many to one and across folders  PDF Creation and population with RAVE data

25  Protocol Team meets to discuss protocol  Curator and Clinical Data Coordinator  Decision on forms  Decision on fields  CDE (Common Data Element) Browser  what exists and what is missing

26  A meta-data element conforming to the ISO/IEC Metadata registry standard  Describes the meaning and representation characteristics of Data (A question and the answer)  What question does this data value answer?  What are the permitted values?  What is its datatype?  Information (metadata) is recorded in a Repository (catalog), that is independent of application programs or database descriptions and therefore reusable across different projects.

27  Linked to controlled terminology to define:  the meaning/context of the data  The question being asked.  the meaning of each value in the value set  The answer to the question asked.  Developed by end user for specific projects (real data)  Available in human and computer friendly formats  Excel download  XML download  Java API  Rest API  Web Browser tools  Wiki pages

28  EXAMPLE OF SEDES D2M form

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33  Background  Legacy Data Entry System  eCRF Standardization and RAVE across LPOs  Using CDE Browser  RAVE folders, forms and fields  Mapping Solution  One to One, many to one and across folders  PDF Creation and population with RAVE data

34  Architect  Folders  Forms  Fields  Data Dictionaries  Custom Functions

35 Home Protocol Institution Patient Folder Form Fields

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41 Data Dictionary within RAVE

42  Background  Legacy Data Entry System  eCRF Standardization and RAVE across LPOs  Using CDE Browser  RAVE folders, forms and fields  Mapping Solution  One to One, many to one and across folders  PDF Creation and population with RAVE data

43  Capture data with one dictionary  Map that data with a different dictionary  Store that data on a new form  Or same form or multiple forms  With the ability to store this in a new folder  Custom Functions do the heavy lifting  Staff maintain the data dictionary mappings

44 Performance Status field with a different dictionary.

45 LPO Dictionary (ECOG_SCALE_PID _V6_1 ) NCI Dictionary (NCI_ECOG_TEST ) Mapping Dictionary

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47 Field mapping dictionary set to copy fields from one form to multiple destinations Form mapping dictionary set to copy fields from one form to multiple destinations

48  Create a corresponding NCI Folder  Place standardized forms in NCI Folder  Automate replication to these forms

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50 User completes the LPO form

51 One LPO form captures data and populates multiple Standard forms

52 A new folder was created at the patient level The folder structure is copied automatically under the “NCI root”

53 Data Dictionary Defines LPO values Data Dictionary Defines NCI values Data Dictionary Defines the linkage Custom Function (C#) populates the fields Edit Check on the LPO form calls the Custom Function

54 Resulting Edit Check should look as follows

55  One form collects all information  LPO and NCI on same form  One form populates multiple forms  LPO questions from one to multiple NCI  Multiple forms populate one form  Multiple LPO forms to one NCI form  Copying folder structures is worth exploring

56  Custom Function requires the following conventions to make this portable across RAVE instances:  NCI folder name  Driving Data Dictionary names  Use of Data within the Data Dictionary  Study Builders will maintain the Mapping Dictionaries and not IT staff. Once built, these are portable across an LPO’s protocols within RAVE.

57  Background  Legacy Data Entry System  eCRF Standardization and RAVE across LPOs  Using CDE Browser  RAVE folders, forms and fields  Mapping Solution  One to One, many to one and across folders  PDF Creation and population with RAVE data

58 Institution Staff logins to RAVE Keys data onto RAVE screens Web Services pushes data to Data Center Data is populated on PDF Web Service pushes PDF back into RAVE

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60 Specimen Consent Click the Baseline Folder icon Answer questions and hit Save

61 Patient Root – Before & After Translational Research Folder Mandatory TR Forms Due Click the Translational Research Folder to generate the TR forms for shipping

62 TR Driver Form

63 Complete the TR form

64 Enter Data The institution staff completes the form and hits save to submit the data

65 Save data, hyperlink created Hyper link to the transmittal form

66 Click, print and ship

67 Thank you for your time

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