Presented by Ueng-Cheng Yang ([email protected])
Institute of Biomedical Informatics
National Yang-Ming University
Implementing the CDISC standards
into an existing CDMS
TCT is a resource center to support clinical trials for the
National Research Program for Biopharmaceuticals (NRPB)
Protocol application information was collected
by a protocol tracking and management system
http://www.cims.tw/
Specimen
High throughput data
Analysis
Patient
Clinical information
Protocol, informed
consent, etc. year
S ur vi va l % + + + -- + -Protocol Tracking and Management System Clinical Data Management System Specimen Tracking & Management System
Integrating data
by using a g
lobal unique identifierThe trial summary (TS) data can be downloaded
as xml files
The downloaded xml file was not CDISC-compliant, so this file has to be converted into a CDSC-compliant xpt file.
Submit protocol to
one center’s system
Application
form
Attached files
Submit xml and zip files to
another center’s system
Relevant parts of the
submited protocol
Simplify the application of a
multi-centered trial by using
the same information system
in 14 medical centers.
Converting trial summary (TS) data
according to SDTM standard
More than 80% of the 13 clinical trial consortia
are using the same CDMS supported by TCT
Resource center helps users to make the
electronic clinical report forms (eCRFs)
Design and generate forms Manage patients Collect data Export & analyze data Set up access rights Randomization
System
setup
Screen patientsStudy
setup
Study
eCRF used before adopting the CDISC standards
The title of each question, the units, the range of normal values are
Making annotated CRF in an existing CDMS
Making annotated CRF by following the
standard variable names and data types
Provide users a codebook for data query or
analysis
Even though a user is not familiar with the CDASH and SDTM standards. He can stilll make query or analyze data based on this codebook.
Using a finished phase I trial as an example
to test the workflow approach
Collected data will be validated based on
rules after completing an eCRF
This validation only focuses on a single eCRF. The consistency among eCRFs will not be checked at this
Click this button for detailed
information
A single mistake may violate many rules
The age of patient SCAI-04 was missing, which lead to these 5 violations of rules.
Correct the error and re-check this eCRF
When research nurse corrected the error and froze the eCRF again, this eCRF was checked again. Since the status was “all passed”, this eCRF was locked.
Using a finished phase I trial as an example
to test the workflow approach
Data tabulation steps are semi-automatic. The most time consuming part is manual transversing rows and columns.
All domains were exported to a single Excel
worksheet
Exported data were manually separated based on SDTM domains into different worksheets.
Converting xlsx files to xpt files by using SAS
The data were converted to xpt format directly without statistical analysis in this proof-of-concept study. In other words, the ADaM standard is not discussed here.
Import Excel files into SAS
Export tabulation results in xpt format
Using a finished phase I trial as an example
to test the workflow approach
Validating data sets by using the OpenCDISC
resource
The define.xml file was generated by using OpenCDISC resource. This file and the xpt files were validated by the validator tool.
Validation report showed that some required
data were not collected in this trial
The users designed the CRFs themselves based on the needs in
science. As a result, a few compulsory information were not collected. Previous validation step on CRF was based on the variables in the
