CRF Manager Project
demo of CRF management (avi)
(each page in the demo contains a brief presentation as well as the demo's menu in the bottom)CRF Manager exemplifies the use of Service Oriented Architecture and Web Services for managing the case record forms (CRF) in clinical trial industry. Clinical trials (CTs) are research studies conducted to answer specific questions about new drugs and devices or new approaches to using known treatments. They are used to determine whether new drugs or treatments are both safe and effective. Carefully performed clinical trials are the fastest and safest way to find treatments that work. In order to facilitate the CT enactment and execution, and improve the CT quality many activities in the Clinical Trial Management are partially automatized. Nowadays an even more automation of CTs is required.
CTs have to be scientifically sound. This is why they are described in a clear detailed clinical trial protocol (or study protocol) . The CT protocol describes the objective, design, methodology, statistical considerations, and organization of a clinical trial.
A Case Record Form is a paper or electronic (e-CRF) document designed to record all the information for an individual study subject (patient) required by the CT protocol. CRFs are used to ensure data collection in accordance with the CT protocol, to facilitate the effective, comprehensive data processing and analysis, results reporting, and to promote the safety data sharing between the study team and other stakeholders. CRFs are designed during the early steps of the CT by the Co-ordinating Center. After a CRF is designed, during the CT setup phase, the Co-ordinating Center must publish it for being accessed by the Study Centers that (in the case of a multi-centric CT) are remotely distributed. Then the Co-ordinating Center must wait for the completion of the CRF data from the Study Centers. These, in turn, should make use of specific services that facilitate the transfer of information back to waiting Co-ordinating Center. So, after the CRF completion, the Study Center sends it to the Co-ordinating Center for further verification, storing in the CRF database, and final statistical analysis.
The CRF Manager project deals with CRF management during the whole life-cycle of CRFs in clinical trials. The use of electronic CRFs (e-CRFs) was chosen because it enables us to improve the overall quality of the collected data and the collecting process itself.
CRF Manager is a distributed application which publishes services that cover the whole life cycle of CRFs. The services can be discovered and accessed in web either from traditional workstations as well as from PDAs. Here is a list of these services:
1. CRF template defining service is provided by the Co-ordinating Center's server and used for editing CRF templates that will be sent to the study centers in order for the lasts ones to collect CRF information.
2. CRF data collection service. this service is provided by the coordinating center server and is used by the SC web clients for filling into the system the CRF information and sending them to the CC for further verification and results evaluation.
3. CRF template download service is a web service provided by the Co-ordinating Center and used by the remote devices to access and download the CRF templates previously designed. This service must retrieve only those templates that have not been previously downloaded in the PDA's or workstation's memory.
4. CRF data upload service is a web service provided by the coordinating center server and used by the remote devices to upload all the information regarding the CRFs, namely the data the investigators collected from the subjects. After the CRF has been uploaded, it can be verified and stored in the CRF database. From CRFs in the database statistics will be easily made for the final result evaluation.
The application is designed to be deployed in the Co-ordinating Center and Study Centers, and supported by the following resources:
Application Server that hosts the business logic of the system
Database Server that ensures the persistence of data in the system
Web Services Server that supports the CRF Manager Services
Web Server that provides the necessary interface between the application server and the client user interface.
Sponsor: The application was implemented by Eng. Florin Istoan for his bachelor's thesis (Thesis title:"Service Oriented Architectures for Managing Clinical Trials").
Environments/Tools used :
ASP, and .NET Framework 2.0 ( C# based). For
the PDA smart application is implemented also using C# but in this case .NET Compact Framework 2.0 for PDA and SmartPhone devices was used.
Activity description : Project manager.