Data Management
The following elements of Clinical Data Management service ensure the success of your project:
Planning
A REGISTRAT-MAPI Data Management Plan is not just a collection of specifications; it's a genuine plan, progressively elaborated, that provides guidance for the collection and cleaning of the data. Because there can be diverse sources of data, we outline clear data flows (that still enable complex data to be captured, when necessary), reconciliation processes, and cleaning methods.
Investigator and Patient Focus
Late Phase Investigators are often research naïve, and study participation is discretionary. Data Management can promote site and patient retention by providing clear, convenient data collection forms, patient visit reminders, and by linking grant payments to good performance. We often deploy several collection mechanisms in each study, including EDC, paper, and telephone interviews tailored to the convenience of the participants.
Cleaning Methods
Because clinical monitoring in Late Phase studies is infrequent, if it occurs at all, we cannot rely on source document verification of clinical data. Instead, we develop sophisticated edit checks to trap errors, and we avoid burdening the sites with a high volume of queries. REGISTRAT-MAPI's electronic Case Report Forms (eCRFs) promote clean data entry, while online edits trap errors efficiently. Our paper forms are designed to be logical and unambiguous. Grant payments are linked to the delivery of clean information, promoting compliance.
Flexibility
REGISTRAT-MAPI deploys a variety of data collection mechanisms to promote participation and compliance. When a study lasts for years, changes are likely; REGISTRAT-MAPI's Data Management staff, processes, and technology are prepared to collect additional or changed information. We have developed and deployed sub-study data collection mechanisms during an active study. For instance, REGISTRAT-MAPI also delivers special subsets of data to investigators who run their own studies. Working closely with our biostatisticians and programmers, REGISTRAT-MAPI frequently provides reports and data to support publications and presentations on short notice.
Late Phase data collection is characterized by:
Data Collection Technologies
EDC System Design / Implementation
The REGISTRAT-MAPI Data Management group will design and implement REGISTRAT-MAPI EDC based on study-specific EDC requirements developed in cooperation with the sponsor and REGISTRAT-MAPI professionals.
Electronic Patient Reported Outcomes (ePRO) Solutions
Depending on study requirements, REGISTRAT-MAPI can use multiple technologies to collect PRO data. REGISTRAT-MAPI’s Web-based ePRO system allows users to enter data in an interview based format. Behind the interview is a complex data collection system that integrates an easy-to-use form with simple to complex error checking, tree guided interview paths, automatic notifications, and rapid setup features.
Interactive Voice Response System (IVRS)
REGISTRAT-MAPI’s IVRS integrates state-of-the-art information systems and computer and telecommunications technologies to provide a scalable solution that can be combined with other REGISTRAT-MAPI technologies. Our combination of technical expertise, clinical research experience, and IVRS experience allows us to provide centralized randomization, collection of patient reported outcomes, and drug management services for Late Phase studies and registries, as well as other applications that may be needed in the course of a study.
Patient Reported Outcomes (PRO)
The IVRS allows patients to enter study related diary information or complete PRO instruments using a touch-tone telephone. Given the prevalence of telephones this is a preferred data collection method for patient reported outcomes. Typically, study sites enter or initialize enrolled patients into the IVRS, following which, patients can begin to enter diary information or complete PRO instruments.
Event Reporting
To streamline the reporting of specific events throughout the course of a study, such as serious adverse events, IVR can be used as a trigger to initiate manual processes or use of other technologies. The IVRS can receive information that can be triaged at REGISTRAT-MAPI, automatically sent via fax, or entered for review. Using multiple integrated technologies, processes can be streamlined and events tracked with a high degree of timeliness and accuracy.
REGISTRAT-MAPI Electronic Data Capture
REGISTRAT-MAPI uses a comprehensive, flexible, and 21 CFR part 11 compliant system designed to create efficiencies in the work flow process for clinical studies, enhance data accuracy, and in doing so, accelerate clinical study timelines. The Data Management module includes an eCRF creation tool, Designer Work Bench (DWB), the industry’s simplest drag and drop graphical tool. DWB enables data management professionals to easily design case report forms, create data validation rules for automatic edit checks, define code or decode lists, and automatically configure underlying database schema corresponding to each form. This process that typically takes six to twelve weeks can be done more expeditiously using DWB, depending on form elements, data cleaning strategies, and field types identified in the eCRF development process.
Visit the Data Collection Technologies section to learn about key features of the REGISTRAT-MAPI EDC syste.
REGISTRAT-MAPI EDC is based on thin client architecture, and thus, requires no installation or downloading for study sites, participants, or the Sponsor. The core EDC solution, accessed via a secure Web page, includes customizable Web-based data entry screens, query management, built-in reporting capabilities, and a host of communication and reminder features. It is designed to provide quick study startup and powerful, flexible, on-going study administration.
The application is accessible via any system capable of supporting a mainstream browser with a connection speed of at least 56 kbps. REGISTRAT-MAPI EDC is a hosted application that features state-of-the-art physical and technological security to provide a tested, secure, and reproducible environment for data collection and storage.
Fax Scanning
REGISTRAT-MAPI's fax scanning system consistently delivers quality data using an established methodology. Sites will appreciate the ability to fax Enrollment Forms directly into REGISTRAT-MAPI and experience fast turnaround as they are imported into the REGISTRAK® Site Management System. Enrolled sites can fax Case Report Forms (CRFs) to REGISTRAT-MAPI for integration into REGISTRAT-MAPI's Clinical Data Management System (CDMS).
REGISTRAT-MAPI's highly skilled Data Management group can create customized forms for high-speed scanning or fax receipt based on study requirements. Scannable forms use anchor points to define fields, field types, and form flow. Forms can be disseminated to sites by mail or via a secure Internet portal.
Once forms are deployed, REGISTRAT-MAPI maintains both fax server capabilities and high-speed scanners to receive images. These images are exported to both the Optical/Intelligent Character Recognition (OCR/ICR) system and to REGISTRAT-MAPI's imaging system.
The OCR/ICR system software interprets the images and automatically performs OCR/ICR extraction, highlighting questionable entries to be reviewed by an operator. All fields are 100% verified to ensure completeness and accuracy of the database. Because the OCR application processes the majority of the information, entry operators spend seconds verifying questionable data rather than minutes manually keying entire forms.
Technology plays a significant part in a successful fax scanning system. REGISTRAT-MAPI's dedicated fax servers are available 24/7 for sites to fax CRFs or other data to REGISTRAT-MAPI. Our OCR/ICR system resides on redundant servers to ensure that information is processed quickly and efficiently. REGISTRAT-MAPI's OCR/ICR system is hosted in REGISTRAT-MAPI's secure hosting facility.