Clinical Data Services (CDS) Overview
Research Translation Research Network ( RCMI CC ) Clinical Data Services supports research using practices designed to improve data quality and promote efficiency. We provide expertise in all areas of Clinical Data Management, from study start up to database lock, meeting best clinical practices and ensuring data integrity.
The Clinical Data Services use a methodical approach to translate a research concept into a concrete method of collecting, organizing and verifying data to promote accurate reporting and data analysis. Clinical Data Services work closely with each study team to develop a system that integrates well with research practices and effectively manages the data. We create study-specific data collection instruments as electronic Case Report Forms (eCRFs), and use a web-based application with built in security features for the research database.
Throughout the life of the project, we provide the necessary services and expertise to help manage and report data, providing clean data sets as needed. The Clinical Data Services Division also works collaboratively with other RCMI CC units in order to supply researchers with comprehensive services that can streamline, and coordinate the many facets of a clinical research project such as standard CRFs, which leads to standardize annotated CRFs, programming, etc.
Through frequent coordination with project teams, Clinical Data Services Division provides a seamless flow of data and a constant level of communication to ensure that projects meet deadlines and milestones. Our data management teams fully understand and comply with Good Clinical Data Management Practice (GCDMP) and Clinical Data Interchange Standards Consortium (CDISC) standards.
What is Data Management?
Data management is preparing a database application to receive the data, designing edit checks to protect against entry errors, entering the data, choosing between full and partial double-data entry, generating data queries to clean the data, validating the data, writing code for administrative reports, and exporting the data to the statistician's SAS program.
Clinical Data Services (CDS) Capabilities
CDSI has been a cornerstone of our clinical research services here at RCMI CC Data Collection Center. Our team of highly skilled Data Managers has amassed more than 35+ years of expertise. The team of Data Managers is well versed in Good Clinical Data Management Practices (GCDMP), Clinical Data Interchange Standards, ICH Guidelines and all applicable laws and regulations to implement FDA-regulated and non-regulated studies. In addition, the team has strong technical, programming, and communication skills. The CDSI leadership has worked with Pharmaceutical companies and Contract Resource Organization (CROs) in U.S., European and Caribbean markets. They are recognized as being a Certified Clinical Research Professionals (C.C.R.P). Our clinical data programmers have years of experience with SAS programming, program validation checks, data listings and much more being a IBM DBS Certified Specialists. The team’s expertise covers diverse therapeutic areas including HIV Questionnaires, Oncology, Cardiovascular, Gastrointestinal, Hematology, Rheumatoid Arthritis, and Psoriasis.
Our Clinical Data Management staff is actively involved with the Society for Clinical Data Management (SCDM), Society of Clinical Research Associates (SoCRA), Drug Information Association (DIA), and the Clinical Data Interchange Standards Consortium (CDISC). The RCMI CC Clinical Data Services Division can support your Phase I up to Phase IV studies, provide a customized, cost-effective, and flexible approach to meet all of your data needs.
For project consultation, contact Alnida M. Ngare at Alnida.Ngare@rtrn.net, 601 979-0335 or complete the “Request For Services” form on the right.
Our clinical studies are managed utilizing industry leading applications and tools. RCMI CC ’s Clinical Data Services provide investigators with all the necessary training required to conduct successful trials adhering to required laws and regulations.
Database set-up and production is performed in Oracle Clinical or REDCap.
Oracle Clinical (OC)
Oracle Clinical (OC) 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.
- • Provides a single application and infrastructure for EDC and CDM
- • Supports flexible modeling studies with complex trial design scenarios
- • Defines multiple potential pathways a patient might take through a study
- • Enforces standards and consistency with global library
- • Delivers full integration with Oracle Remote Data Capture
Research Electronic Data Capture (REDCap)
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.
- • User-friendly web-based case report forms
- • Real-time data entry validation (e.g. for data types and range checks)
- • Has an audit trail
- • Able to set up a calendar to schedule and track critical study events (e.g. blood-draws, visits)
- • Assign different levels of access for each member of the research team
Clinical Trial Management System (CTMS)
Clinical Trial Management System (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. CTMS offers several benefits including:
- • 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
The DCC uses 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. The beneficial attributes of the system include:
- • Clinical vs. Safety database
- • Manual identification of discrepancies
- • Query generation/resolution
- • Database modification
- • Repetition, until perfect
JReview is the web-enabled version of Integrated Review. It allows users to view, create, print, and interact with their Integrated Review objects locally on an Intranet or securely over the Internet. JReview can be run in two different modes of operation (authoring and non-authoring) in addition to two modes of communication (clear-text and SSL).
Our CDSI team aims to provide services that streamline the start-up, implementation and reporting of database functions for clinical and translational research across the research community.
Clinical Data Services
Data Coordinating Center (DCC) Clinical Data Management team will work with you to provide high-quality data that will meet the needs of your clinical trials and regulatory agencies.
Our services include:
Manual of Procedures (MOP) development
A study Manual of Procedures (MOP), is developed to facilitate consistency in protocol implementation and data collection across participants and clinical sites. Further, the MOP provides reassurance to all participants that scientific integrity and participant safety are closely monitored and increases the likelihood that the results of the study will be scientifically credible.
The DCC recognizes the importance of a MOP and has expertise in MOP development to help transform the study protocol into guidelines that describes 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 (CRFs), and quality control procedures.
Case Report Form (CRFs) Development
Good Case Report Forms (CRFs) are crucial in conducting a successful clinical trial. CRFs capture data that will be used to evaluate the research questions asked in the protocol and to collect adverse event data for safety reports and processes. Working together with programmers and statisticians to ensure they receive the needed information to analyze the study appropriately, DCC team can assist you with CRF development in the following ways:
- Design CRFs for paper and EDC studies
- Review site made CRFs
- CRF Annotation
You need a robust system to capture and store your clinical trial data. The system should be secure, intuitive, easy-to-use and meet the specific needs of your study. DCC uses industry leading software packages that support paper and electronic data capture (EDC) studies. Our experienced database development team builds custom, secure applications that are 21 CFR part 11-compliant.
The databases we develop and deliver include:
- eCRFs (REDCap)
- Case report form tracking system
- Data entry screens that mimic case report forms (paper-based) (Oracle Clinical)
- Automatic and manual edit query system
- Full audit trail
- Database validation and documentation
- FDA-compliant 21CFR part 11 databases
- Electronic signatures (EDC)
To present data for review, you need to provide clean data. This is where our data discrepancy management is involved. We can produce a Validation Management Plan (DMP) that will be programmed to look at the data for consistency across all subjects and sites. We provide:
- Data Clarification Forms (DCFs) to the sites
- Check the database to make sure the database has been updated.
Quality Control (QC)
Before a database is locked, we perform a quality control check on the data to make sure that we provide you with the cleanest possible data. Throughout the course of the study, a sample of the database is compared with corresponding CRFs, and DCFs. The sample will consist of randomly selected CRFs based on:
- 10% of the subjects enrolled
- 100% of the critical variables
This is the moment that everyone has been waiting for from the beginning of the study. But before we can lock the database, we make sure that all activities have been completed by checking our database lock check list.
• Case Report Forms completed or all information entered into the database
• All Data Clarification Forms (DCFs) collected and reviewed
• Medical coding approved (if applicable)
• SAE Reconciliation (if applicable)
• Final Batch Validation/line listing review
• Quality Control (QC)
• Safety/Efficacy discrepancies resolved (if applicable)
If all of the above has been completed, we then lock the database and provide the client with clean data.
Clinical Data Services and Informatics have the following applications to support Clinical Data Manager needs:
- Applications for Clinical Data Management (CDMS): Oracle Clinical and REDCap
- Applications for Electronic Data Capture (EDC): Oracle Clinical-Remote Data Capture (RDC)
- Applications for Safety Data Management: Oracle Argus
- Seibel Clinical Trial Management System (CTMS): Maintenance of site and personnel information, generation of CRA visit reports, and issues management