CLINICAL DATA MANAGEMENT

Case Report Form (CRF) Design: Using the study protocol, BioScien, Clinical Data Management Team prepares and formats data collection forms indicating study data fields to be collected and, where appropriate, allowable responses for each field. Consideration is given to design the CRFs in a user-friendly manner in order to minimize entry errors, and study CRFs are formally reviewed by the client prior to implementation.

Clinical Data Management Plan: Using the approved study CRFs, BioScien develops detailed database design specifications (DDS) for each client’s clinical study database. Each DDS includes the form name, event name, event structure, data field definitions, code-list and automated edit checks. Based on the DDS, BioScien team members prepare the written data management plan, which includes CRFs, annotated CRF, Group and User Set-Up Request Forms (for EDC study), Risk Analysis assessment, Database Development Checklist, Database Validation Plan, User Acceptance Test Plan, Data Processing Guideline, In-House CRF Review Guideline, Data Cleaning Guideline, Validation Report, User Acceptance Test Report and Database Lock Check List. Data management plans are formally reviewed by BioScien and our clients annually and maintained using version control.

Clinical Database Development: BioScien clinical databases are based on a Microsoft SQL-based platform. Study-specific data entry screens, back-end tables, and automated edit checks are programmed and validated in accordance with the data management plan and 21 CFR part 11 requirements

Clinical Data Entry, Data Processing, CRF Review, Query Resolution: With BioScien EDC system, study data is entered via a secure Internet connection by the study coordinator. Pre-programmed automated edit checks are utilized to provide controls for data entry accuracy. During site monitoring visits, data entry accuracy is also confirmed by the visiting clinical research associate.

With BioScien paper CRF system, completed CRFs, reviewed and collected in conjunction with monitoring site visits, are forwarded to BioScien where they are logged and entered into the database. Double data entry is performed by two different data entry coordinators, and discrepancies are adjudicated prior to finalization of entries. Data entry personal are trained on the specific data processing guidelines, and pre-programmed automated edit checks are utilized to provide controls for data entry accuracy.

Meanwhile, BioScien EDC paper double entry functionality provides flexibility to sponsors who prefer a hybrid method of data collection.

Clinical Data Review & Query Resolution Data inconsistencies that are not detected by automated edit checks are reviewed per the In-House CRF Review Guideline. Using either paper or electronic DCFs, additional queries may be generated and transmitted to the study site.

BioScien clinical database allows for tracking of CRFs received by site and by subject. Additionally, each DCF generated and its associated resolution status is tracked

Data Dictionary Processing: BioScien provides data coding services for adverse events, medications, and medical history. Typically using MedDRA and WHO DRUG, coding listings can be provided regularly for sponsor review.

Data Imports: Written data import protocols are co-developed with the central lab or reading center and submitted to the sponsor for approval.

Data Exports: Using BioScien clinical study management, data can be easily exported into a number of formats including Excel spreadsheets, SAS datasets, ACCESS tables and ASCII files.

Data Quality Assurance: Typical data quality assurance procedures include generation and review of data inconsistency listings, confirmation of randomization schedules, data entry versus source data and resolution of data queries. Additionally, ad hoc data reports are developed to provide study data analysis and metrics to clients, as required, on an ongoing basis throughout the study conduct.

Database Lock and Data Transfer: Upon successful completion of necessary data quality assurance procedures and a data lock checklist, BioScien locks the clinical study database and the data is transferred to the designated biostatistician for analysis.

Database Maintenance and Archival: BioScien maintains clinical databases for the duration of the project, and typically through completion of the final clinical study report. Subsequently, clinical study data is transferred to our client in their designated format and archived as specified in the project agreement.

Security Procedures: Clinical data security is enforced via use of a single user and password sign-on for qualified, registered database users. Specific access roles are granted as appropriate, and user passwords are changed at specified intervals. Audit trails of server and record access provide comprehensive tracking of modifications made to data or programming files.

BioScien systems are configured to facilitate rapid restoration of data in the unfortunate event of server failure. Clinical data and programming files are stored on servers located in a secure, environmentally controlled area.