This is an integral module
of CTMS, acting as a
backbone for clinical
studies. Study management
defines the guidelines of a
study plan. Various aspects
of study such as Arm, Site,
Therapeutic Area,
Indication, Research
Organization, Ward, Contact,
Organization, etc. are
managed using this module.
Event Management:
The outcome of the study
must be documented, both in
case of
Normal
and Adverse Events. It
allows eCRF Management. CRF
can be created within the
application and
corresponding data is
entered and maintained in
CRFs.
Subject Management:
Participants of research are
referred as Subject. It may
comprise of patients or
volunteers. This module is
capable of managing the
entire process of Subject
Recruitment and Enrollment.
All the subject details such
as race, trait, etc. are
maintained within the
application.
User Management:
Clinical studies consist of
several participants and
stakeholders. This module
allows for User Management
and User Creation.
Corresponding Roles and ACLs
can be assigned to users.
Functions such as task
allocation, task scheduling,
signature, etc. can also be
performed.
Report Management:
Allows the generation of
custom reports using data
sets. Queries can be fed
into the query builder.
Reports can be in the form
of tables or graphs. It also
allows for subject tracking.
The major types of reports
generated are as follows: + Managerial Reports
+ Administrative Reports
Configuration Management:
The Administration module
provides various tools for
application configuration.
Functions such as Audit
Trail, Log, Custom Field
configuration, Document
Attachment, etc. can
specified by the
administrator.
