Services and the number of production staff provided to
each OC CAB client vary because the services and number
of staff are customized to match each client’s needs.
The following is a description of the services provided
by OC CAB staff:
Process
modification for RDC and CDISC integration
It
is critical to modify the existing legacy processes to
leverage the full functionality of RDC Onsite. Reengineering
of the process can also present an opportunity to align the
extraction datasets with SDTM requirements. Two key pieces
for making this happen are customization of the technology
and modification of the legacy processes. Process changes
will encompass changes to the study/database design elements
and changes to study conduct processes. Training, ongoing
support and roll out of the modifications should be clearly
planned.
Customization of the technology entails the
following:
- System level
configuration changes. Programming of site/study
specific links etc, enabling site access to the updated
information about design modifications and study
conduct.
- Creation of a company
specific form template including integration of company
logo on the RDC screen display.
- GLIB modifications and
creation of RDC specific metadata including check boxes
etc.
- Programming,
maintenance and customization of core DCMs which can be
used as standards.
- Programming of graphic
layouts and RDC screen designs.
- Design and programming
of site friendly, standard edit checks.
Process component can be further subdivided
into customization of Study design processes and Study
Conduct processes.
Study Design:
-
Mock CRF
design in contrast to legacy CRF design
-
Database
specification and communication to design team
-
Standardization of GLIB metadata
-
Implementation of standardization and ongoing
maintenance of standards
-
Creation
process of study specific edit check specification using
standards
-
Database
build validation process and tools
-
Edit check
validation process
-
Development of DE guidelines
-
Development of SDTM compliant SAS datasets and
annotations.
Study Conduct:
-
Discrepancy management in RDC studies
-
Process
clarification of onsite and offsite responsibilities.
-
Data
listing review for data cleaning and monitoring
-
Communication process with sites
-
Discrepancy resolution oversight/QC
-
Study
closeout
System Installation, Validation and Maintenance:
- Validation and/or installation of current versions of Oracle
Clinical™/TMS/AERS and RDC
- TMS installation and validation. Dictionary updating, maintenance
and set up of virtual dictionaries
- Installation and validation of NLV (Normalized Laboratory View)
or other client package for lab data setup and processing
System Architecture and Functional
Process Review:
- Setup an/or review Oracle Clinical™ system architecture to
maximize efficiency and system functionality
- Functional process review to ensure business processes and work
flows support Oracle Clinical™ functionality
- Review and/or development of SOPs and Work Instructions as
appropriate for:
- CRF
design and development.
- Database design, development and testing
- Validation and derivation procedure programming
- Oracle
Clinical™ views and SAS datasets
- Lab system setup and maintenance
- Randomization
- External data loading
Database Development and Operations:
-
Database design, development and testing
-
Programming and
testing of validation and derivation procedures
-
Global library
development and maintenance
- Randomization
generation and use of inherent functionality of Oracle
Clinical™. Unblinding
and drug derivation procedures
-
Creation of Lab
sub-system including lab value definition and lab normal
range setup
-
Methodology for
creating standards and testing of Oracle Clinical™
views and SAS™
datasets
-
Data entry
processes testing
-
Programming of data
listings and summaries in Integrated Review™,
Toad™,
Oracle Discoverer™
or other reporting tools
-
Set up of
investigators, sites and centers
-
Database build QC
and Lab setup QC
Data Management:
Study Startup Planning and
Development
- Project
timeline development and maintenance
- CRF
development, based on protocol requirements
- Data
Management Plan component development
- Project
Notebook development and maintenance
- Data
validation document (DVD) development
- Self evident
correction document development
- Database lock
documentation and procedure development
- Test, review
and approve database and data entry screens
- Test, review
and approve validation procedures
Data Entry
- Study
Subject position data entry into Oracle Clinical™ database
- First pass and second pass entry into
Oracle Clinical™ and verification
- Receipt, tracking and storage of CRF pages
- Data entry
guideline development
Discrepancy
Management and Query Processing
- Discrepancy review
- Data Clarification
Form (DCF) distribution
- DCF resolution
- Clinical Coding
- Reporting using
Oracle Discoverer™
- External vendor
data review and discrepancy processing
- Lab data review
