Multicenter Studies Support

The Integrated Information Management System (IIMS) has the following data components:

 

Web Portal

Web portal is an integrated container that hosts multiple data components a trial project required. The Web portal provides a feature of having single sign-on to authenticate a user’s access credential. With the user role based configuration within the system, the Web portal allows users to access the data components only with their configured role assignment. The Web portal allows a user to change the password when it is necessary.

 

Online Subject Registration

Online Subject Registration (OSR) is to allow a trial participating site to register a subject locally and stores the registration data into a central database. Before allowing registering a subject, OSR checks the participating site’s IRB approval status and only allows to register with the updated IRB approval status. OSR collects data of subject recruitment status, informed consent and eligibility checklist and then creates a unique identification number (SID) to each registered subject. OSR is one of the data component’s within Data Management Initiative (DMI) application.

 

Clinical Data Capture

Clinical Data Capture (CDC) is to collect all trial required clinical data for a subject. The trial required clinical data includes subject survey, CT screening tracking and other data elements. CDC offers the electronic features of subject calendar setup, on event data query and event data validation, completion, lock and etc. CDC is one of the data component’s within Data Management Initiative (DMI) application.

 

For subject survey data, CDC also offers the subject self-report function on a tablet PC device, i.e. with the guidance of a research coordinator, a subject is filling out the survey via a tablet PC device and then input the electronic signature with a stylus. This process eliminates the paper.

 

 CDC self-report feature supports Microsoft Surface Pro 3 and all other Windows based laptops.

 

Tissue Specimen Tracking

Tissue Specimen Tracking (TST) is to collect blood sample collection, processing, storage, sample shipping and receiving for a subject. In the current TST, shipping and receiving function is not part of the application. It has been implemented onto the secure collaboration site.

 

CT Imaging Repository

CT Imaging Repository is to allow users from the participating sites to upload CT imaging files including both CT raw data and DICOM files.

 

Document Management

Document Management is to collect all project related documents including regulatory, subject source and protocol. This data component is developed as an application of Electronic Document Management System (EDMS).

 

Online User Support

Online User Support (OUS) is to allow users to create an issue ticket to the associated supporting group at MDACC.

 

Secure Collaboration Site

The Secure Collaboration Site is a newly developed site that provides a central, secure site collaboration electronically. The Secure Collaboration Site offers multiple functions including document content management, reporting services, workflow approval, etc.