 |
|
|
 |
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.
|
|
|
|
