Data Management Services
- Review of Clinical Protocols and CRFs
- Protocol Design
- CRF Design
- Project Management
- Data Management Plan
- Project Documentation – Project Specific Procedures
- Database Design and Development
- Double Independent Data Entry
- Data Edit Specifications and Edit Reports
- Data Review Listings
- Medical Coding: MedDRA, Costart, WHO-Drug
- Quality Control – Data Quality Reviews
- Validation of Database Design and Development, Edit Reports, and Data Review Listings Databases
- Electronic Data Handling
- Electronic Data Transfers
- Data Back-Ups and Archival
- Online Data Viewing
- SOP Development
ClinDatrix provides experienced, in-depth review of the clinical protocol and supporting CRFs, examining the documents for consistency, completeness, accuracy, and suitability to capture the data required to meet the clinical investigation objectives.
ClinDatrix designs and generates study protocols based on client input and world class standards. The process involves multiple stages of review and relies on the expertise of representatives in data and clinical management as well as biostatistics. A protocol timeline is developed and closely adhered to so that our clients are aware of every step of the process, from protocol synopsis to final protocol approval.
ClinDatrix designs CRFs to accurately and completely capture the data required by the clinical protocol, paying attention to ease of use by the Site Coordinator, the Clinical Monitor, the Data Manager, the Biostatistician, and Clinical Operations. We work closely with our clients to meet all the requirements and expectations for the study. CRF design may be based on mock-ups provided by the client or on industry standard CRF designs.
ClinDatrix works in partnership with our clients throughout the project to jointly achieve the goals of the clinical investigation. The assigned Project Manager will use several methods of communication to facilitate this partnership including: documentation (e.g. data management plan, contact matrix, timeline, project specific processes and procedures); correspondence by memo, e-mail, and newsletter; teleconferences and face-to-face meetings documented by timely minutes, as well as standard and customized status reports delivered per an agreed-upon schedule.
ClinDatrix prepares a comprehensive road map for the Data Management of the clinical project. Included in the Data Management Plan are a contact matrix, a project timeline, a description of systems and processes used, a CRF flow diagram, and a responsibility matrix. The Data Management Plan provides documentation to the project team on the planned conduct of the Data Management component of the clinical investigation. The Data Management Plan may be generated from a template provided by the client or from the ClinDatrix standard template.
ClinDatrix sets up and maintains a Project Binder and Project Files to contain all documentation for the Data Management component of the clinical project. Included in the Project Binder and Project Files are Protocol Specific Procedures customized for the clinical protocol, which supplement ClinDatrix Standard Operating Procedures.
ClinDatrix designs the clinical database utilizing sophisticated technology to ensure the accurate and complete capture of data from the CRFs for the clinical protocol. The clinical database may employ standard naming conventions provided by the client or may use the ClinDatrix standard data dictionary.
Two data entry processors will conduct first and second pass data entry independently. An experienced data manager will then review the comparison report between the first and second pass data entry and will make the determination as to the correct database entry in the case of mismatches.
Edit specifications will be written, reviewed, and programmed. All the edit checks will be tested before being used to validate the data in the database. The edit specifications will be detailed to include the logical checks as well as the messages generated when the data fail the logical checks. The messages will form the basis for the Edit Reports to be used during the manual review of the clinical data.
The data review process makes use of not only Edit Reports but also Clinical Data Review Listings in order to inspect all aspects of the data: point-to-point data comparison, data across visits per patient, data across patients per site, and data across the study as a whole.
Experienced and knowledgeable staff will code selected verbatim text utilizing industry standard dictionaries and/or customized dictionaries provided to ClinDatrix by our clients. An intelligent autoencoder will first perform an automated coding for all direct hits. This will be followed by a manual coding for all verbatim text that did not get autoencoded. Coding listings will be reviewed by ClinDatrix and will then be provided to the client for review and approval prior to declaring the coding activity complete, accurate, and final.
ClinDatrix builds in quality throughout the data management process. At designated time points (as defined in the Data Management Plan), a 10% random sample of patient visit data will be inspected by comparing data listings generated from the database against the CRFs. In addition, 100% of critical data variables will also undergo similar visual inspection. The database will pass Quality Control if the error rate is less than or equal to 0.05%.
Edit reports and data review listings will undergo testing and validation to ensure accuracy and completeness.
ClinDatrix can handle electronic lab data, pharmacokinetic data, visual field data and any other electronic data. These data will be incorporated into the final datasets and listings generated for our clients. Validation checks will be designed to verify the accuracy of the patient identification data from these electronic sources compared against the clinical data collected on the CRFs.
Data will be transferred to the client per client specifications in the format required by client systems. As needed, programs will be written and validated to produce the custom data transfers. Prior to any official electronic data transfer to the client, a test transfer will be provided in order to confirm that the format of the data files matches the client specifications and that the transfer process is error-free.
ClinDatrix regularly backs up the clinical data per our Standard Operating Procedure. Back-ups that are stored both on and off-site in an appropriate secure and media safe environment enable speedy and accurate retrieval of the data, should the need arise.
ClinDatrix uses a secure site (SFTP) to post CRFs, tables, listings and reports. Clients log in to the site with a password and may download or upload data to our file server.
ClinDatrix has extensive experience in creating, writing and developing proper clinical data management standard operating procedures.