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Medical & Clinical Research Protocol Management

This application was developed for process management of medical research protocols for General Clinical Research Centers (GCRC), Clinical Research Trials, Sponsored Clinical Trials and Translational Research.
There is specific emphasis on genetic research as well as compliance to various norms that guide such research.
As these applications are web based, researchers are no longer tied down to a location. Multi Researcher, Multi Location research can be centrally coordinated through this software.
Due to the fact that geography is no longer a limiting factor, the scheduling of researchers, support staff and laboratory test equipment becomes a critical factor in making appointments with Patients/Subjects for conducting the research. The software has extensive facilities to manage and schedule resources.

An example of some of the research protocols managed using this software is

- Research to quantify the impact of low-level fetal and early childhood exposures to environmental toxicants (lead, mercury, pesticides etc.,) and childhood development.
- The Translational Research project for children with Fanconi Anemia handles different gene related protocols and is extendable to other Translational Research projects. These trials seek to improve the care of children with serious diseases. The primary goal is to support faculty-initiated pre-clinical and Clinical Translational Research projects and ensure adequate infrastructure to facilitate the rapid completion of these trials.
- A research project to check the efficacy of web based Psychology Counseling by Intervention in Families that have one or more child with Traumatic Brain Injury. This uses web technology for Streaming Video, Video Conferencing, Questionnaires, Self Help Modules, Diadetic Information, etc.

The functions of the main modules of the Protocol Management Software are briefly described below
Protocol Definitions
Information about the protocol, its IRB and other approvals, its study arms, phases and schedules are recorded in this module. This information is used as a guideline to not only schedule resources, but also as a base for quality assurance reports. eSignatures and Permissions for managing the electronic record are also maintained in this module.

Patient/Subject Enrollment, Demographics and Medical History
Once the Enrollment/Exclusion criteria are set up, the prospective patients can be enrolled with reasons as to which criteria were met or not met. Consent and Assent records are stored for future reference. Changes to Consent / Assent are also recorded along with the Patient's/Subject's participation status.
The demographics of the Patient/Subject along with information of family members are recorded against the enrolled Patient/Subject.
The past medical history is also recorded for the Patient/Subject for use in the protocol.

Appointment Management and Resource Scheduling
Appointments with the Patients/Subjects have to be done within the time frame specified in the Protocol Definition. Whilst making the appointment with the Patient/Subject, the resources required for the appointment such as appropriate research assistants, time slots in the laboratories, tissue collection specialists, various technicians, etc. are checked for their availability. Once an appointment is fixed, all persons concerned with that appointment are allocated tasks and schedules for that appointment.
Rescheduling of appointments and enabling / disabling resources based on rescheduling are also a part of the software.
Research assistants collaborate over the web to understand their schedules and commitments and manage their time in the most efficient manner possible.

Patient/Subject Interaction records
During the visit/appointment with the Patient/Subject, various activities take place as required by the protocol. Details about the Physical Examination, Medical History, Medications, Lab Reports are recorded as a part of the research for future analysis.
Comprehensive test results from all major laboratories can be recorded and references to the specific Patient/ Subject interaction, so that analysis on a time line can be understood and researched.

Tissue Sample Procurement
As a part of the research, specially genetic or environmental research, the collection of tissue is facilitated through the software. The researcher can inform the specialized department as to what & when the tissue sample is to be procured, from whom, how the procurement should take place and how the aliquots should be allocated.
Barcodes are assigned to tissue aliqoutes for storage and tracking and forwarded as per instructions of the researcher.
Tissue procurement, and it's storage and analysis thereafter, is done by separate departments under instructions from the researcher. By and large the researcher need only to specify what is done and be intimated when the instructions, or protocol, is completed and the see the results thereof.
Where required, the Tissue Sample Procurement interacts with the LIMS modules described elsewhere.

Questionnaires
An appreciable part of any research is to collect and analyze information through questionnaires. The Protocol Management Software has comprehensive modules to create a questionnaire and administer the survey.
The questionnaire can be composed of various types of questions. To name a few:

- One question: One answer
- One question, select one or many from multiple answers
- Single line, Multi line and essay type answers
- Numeric answers that total to a predetermined amount
- Data and Time type of answers
- Instruction and Information display - Text or Images
  Other features:
- Skipping questions based on previous answers
- Repeat a set of questions based on a previous answer
- Vertical, Horizontal and Menu display layouts.
- Facility to stop, start and restart the partially completed Questionnaires

Ability to view the change history by the administrator
The questionnaire can be filled up on line by a researcher or generated as PDF for manual completion and entry. The system has been tested over wireless and cellular internet connections and optimized for Tablet PCs which can be used in the field by research assistants.
The completed questionnaires can be logically tagged and the data exported to statistical analysis programs for evaluation.

Web Based Intervention for Psychology / Environmental Research
To facilitate studies where the Patient/Subject can interact with the software over the internet, a comprehensive system has been developed to allow complex activities to be managed remotely between the researcher and Patients/Subjects.
Intervention in Psychology studies is one major application for this software. The researcher can create intervention programs comprised of many counseling sessions and each session can be exposed to each participating Patient/Subject. The researcher can monitor and review the progress and release additional sessions based on individual Patients/Subject's needs.
The software not only caters to individual Patients/Subjects but also caters to intervention at the family group level, with individuals in a family interacting one-on-one and jointly, as part of the family.

- Streaming Video movies
- Video Conference
- Diadetic Material
- Questionnaires
- Study Specific modules
- Feedback on activities

Quality Assurance and Compliance
A substantial part of the Research Binder is actually available in the Protocol Management Software. As the information for the protocol, and its day to day progress, is stored centrally, audit is quick and easy.
The software generates a number of reports to show the status of the protocol and the key parameters that determine the quality of the research being conducted. As Adverse Events are also reported through the protocol, the status of the protocol is maintained on a real-time basis.
Digital signatures are widely used to note the identity of the persons making the entries. All key information is required to be entered, as well as verified, so that errors of "commission" are reduced substantially.

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