OC CAB - Services


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:

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

 Database Lock and Validation

• Quality control check of project database prior to database lock
• Completion of database lock documentation

 Remote Data Capture (RDC) Investigator Site Set Up and Training

• Technical Environment
  • Design RDC system security and infrastructure requirements at the site
  • Provide hardware setup and training
• Operational Environment
  • Establish site based discrepancy management specifications
  • Provide site based data entry and discrepancy resolution training
• Support Environment
  • Setup technical support (help desk)