- Protocol review
- Develop the Manual of Procedures (MOP) in collaboration with the sites
- Case Report Form (CRFs)Development
- Custom database development and data specifications
- Database implementation on web-based application
• Database Set-Up (Oracle Clinical (OC) and REDCap
- Production Database
- Clinical Trial Management System (CTMS)
- Argus Safety and Argus Interchange System
- Quality Control (QC)
- Medical Dictionary Coding
- Database Lock
Protocol ReviewWe review the protocol to make sure that the information within the protocol will collect the necessary data that is inclusive for that study.
• Sample size
• Study duration
• Quality Assurance
• Schedule of assessments
• Assessments to be used as source
Case Report Form (CRF) DevelopmentThe Case Report Form (CRF)regardless if it is a paper or electronic is the tool used by the sponsor of the clinical trial to collect data from each participating site. All data on each patient participating in a clinical trial are held and/or documented in the CRF, including adverse events.
• Develop the design of CRFs
• Protocol adherence
• Accuracy of text
• Ease of database set-up
• User friendliness
Database Set-UpOracle Clinical is a secure, web-based, clinical research software system that provides an integrated Clinical Data Management (CDM) and Remote Data Capture (RDC) solution. It is the first validated clinical research system at the Data Coordinating Center (DCC) which is maintained as a 21 CFR Part 11 compliant system.
• Execution of individual validation procedures
• Batch validation
• Queries entered into the database
• Sites answers the queries in the database
• Query resolution checked in the database
• Query is closed
Research Electronic Data Capture (REDCap) is a secure, web-based application designed to support electronic data capture for clinical research studies. REDCap is a manual data cleaning process.
• Screen review/testing
• Site entry of data
• Manual data review with listings
• Manual Data Clarification Forms sent
• Manually review the database for changes from the sites
Clinical Trial Management System (CTMS)CTMS Siebel, a secure, web-based clinical trial management software platform to maintain a centralized trial management database for all investigators. It is essential to have a clinical trial management system (CTMS) that will provide on-the-fly visibility to critical trial data and operations milestones, while it meets the changing trial demands of CROs and Sponsors.
• Benefit from a secure, stable and centralized access to multiple sites, trials, and programs
• Collect and manage patient and trial administration data in an efficient manner
• Reduce trial administration costs in a dramatic fashion
• Monitor, schedule, sign and submit trip reports electronically
Quality Control (QC)QC is a process intended to ensure that the data meets the specified requirements of cleanness.
• 10% of the non-critical variables are checked.
(Case Report Forms (CRFs) vs. database).
• 100% of the critical variables are checked. (CRF vs. database).
• Error rate calculated.
• If the error rate does not meet the 0.04% clean rate, another round of QC is performed on additional data.
Manual of Procedures (MOP)The MOP transforms the study protocol into specific guidelines that describe the study organization, operational definitions of the data, participant recruitment, screening, enrollment, randomization, and follow-up procedures, data collection methods, data flow, case report forms, and quality control procedures.
This document is used when multiple sites are conducting the same protocol.
Validation Specification DocumentA process where data is checked for accuracy and inconsistencies after validation is completed. Data discrepancy management includes reviewing discrepancies, investigating the reason, and resolving them with documentary proof or declaring them as irresolvable. If a discrepancy can not be resolved with the data being used, then a data query (Also known as a Data Clarification Form (DCF)) is sent to the site to resolve this issue.
Production DatabaseThe database is put into production after the database set-up has been completed and finalized. Some or all of the following activities can be performed depending on the type of database (OC or REDCap).
• Scheduled batch validations
• Review of all discrepancies
• Data Clarification Form (DCF) creation (electronic or manually)
• DCF resolution
• Database modification
Argus Safety SystemHere at DCC we use the Argus Safety System as an advanced and comprehensive adverse events (AE) management system. Argus is a secure, web-based application provides a platform of end-to-end pharmacovigilance solutions designed to ensure regulatory compliance.
• Clinical vs. Safety database
• Manual identification of discrepancies
• Query generation/resolution
• Database modification
• Repeat until perfect
Database LockAll expected in house or accounted for:
• Case Report Forms completed or information entered into the database
• Data Clarification Forms
• Medical coding approved (if applicable)
• SAE Reconciliation (if applicable)
• Final Batch Validation/line listing review
• Quality Control (QC)
• Safety/Efficacy discrepancies resolved (if applicable)