Bill Elgie Director of IT NRG Buffalo Office GOG Statistical
& Data Management Center Roswell Park Cancer Institute Buffalo,
New York Slide 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 Slide 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 Slide 4 The Gynecologic Oncology Group
(GOG) organized in 1970. 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. Slide 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. Slide 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 Slide 7 Cardiff Software
TELEForms TELEForm PDF Designer Internet Server Slide 8 ActivePDFs
PDFToolkit Slide 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 Slide 10 Slide 11 Color coded patient
calendar Patient Initiated from Registration System Forms
Due/Received Dates Hyperlinks to Forms Images, Instructions,
Uploads,.. Slide 12 Pre-loaded with dates and user names Pre-loaded
drug names by protocol Range checks for valid values and data
checks Slide 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 Slide 14
https://wiki.nci.nih.gov/download/attachments/10861517/CRF_Harmonization_Process.jpg?version=1&modificationDate=1339110157000
Slide 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 Slide 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 Slide 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 Slide 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 Slide 19 1.
Modify the caDSR Database structure 2. Modify the Medidata RAVE
Software 3. Come up with a LPO solution Slide 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. Slide 21 Simply not
feasible Medidatas existing customer base Not within the contract
Slide 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 Slide 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 Slide 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 Slide 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 Slide 26 A meta-data
element conforming to the ISO/IEC 11179 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. Slide 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 Slide 28 EXAMPLE OF SEDES D2M form Slide
29 Slide 30 Slide 31 31 Slide 32 Slide 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 Slide 34 Architect Folders Forms Fields Data Dictionaries
Custom Functions Slide 35 Home Protocol Institution Patient Folder
Form Fields Slide 36 Slide 37 Slide 38 Slide 39 Slide 40 Slide 41
Data Dictionary within RAVE Slide 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
Slide 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 Slide 44 Performance Status field with a
different dictionary. Slide 45 LPO Dictionary
(ECOG_SCALE_PID2015172_V6_1 ) NCI Dictionary (NCI_ECOG_TEST )
Mapping Dictionary Slide 46 Slide 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 Slide 48 Create a corresponding NCI Folder Place
standardized forms in NCI Folder Automate replication to these
forms Slide 49 Slide 50 User completes the LPO form Slide 51 One
LPO form captures data and populates multiple Standard forms Slide
52 A new folder was created at the patient level The folder
structure is copied automatically under the NCI root Slide 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
Slide 54 Resulting Edit Check should look as follows Slide 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 Slide 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 LPOs protocols within RAVE. Slide 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 Slide 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 Slide 59 Slide 60 Specimen Consent Click the Baseline
Folder icon Answer questions and hit Save Slide 61 Patient Root
Before & After Translational Research Folder Mandatory TR Forms
Due Click the Translational Research Folder to generate the TR
forms for shipping Slide 62 TR Driver Form Slide 63 Complete the TR
form Slide 64 Enter Data The institution staff completes the form
and hits save to submit the data Slide 65 Save data, hyperlink
created Hyper link to the transmittal form Slide 66 Click, print
and ship Slide 67 Thank you for your time Slide 68
