Innovative Clinical Research, clinical data management services facilitate efficient access, processing, summarization, and dissemination of data and information. At Innovative Clinical Research, our data management services incorporate leading-edge technology, 21 CFR Part 11 compliant systems, and experienced clinical data management personnel to support both electronic clinical data capture (EDC) and traditional Case Report Form (CRF) double data-entry applications.
Our data management services are scalable to your needs and emphasize well-organized, appropriately documented, accurate and timely processing of your clinical data. Service areas include:
Case Report Form (CRF) Design:
Using the study protocol, Innovative Clinical Research, 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, Innovative Clinical Research 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, Innovative Clinical Research 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 Innovative Clinical Research and our clients annually and maintained using version control.
Clinical Database Development:
Innovative Clinical Research 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 Innovative Clinical Research 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 Innovative Clinical Research paper CRF system, completed CRFs, reviewed and collected in conjunction with monitoring site visits, are forwarded to Innovative Clinical Research 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, Innovative Clinical Research 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.
Innovative Clinical Research clinical database allows for tracking of CRFs received by site and by subject. Additionally, each DCF generated and its associated resolution status is tracked.