Title: Clinical Data Management Tools
1Clinical Data Management Tools
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2Introduction
Most students fail to understand what clinical
data management is and why it is required in
clinical trials. A clinical trial aims to
investigate a research question by gathering data
to prove or disprove a hypothesis. Data is thus
an important aspect of any clinical trial or
research. Clinical data management involves a
host of different activities that manage the data
obtained in clinical trials. Clinical data
management training is thus one of the most
important aspects of clinical research training.
Although almost all researchers get involved in
clinical data management is some way, it is not
necessary for all of them to undertake the
training. Clinical data management courses are
good for individuals who wish to chart out a
separate career as a clinical data manager.
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ent-trainings-hyderabad.php
3Clinical Data Management Tools
- Clinical data management is handled with the use
of a number of software tools. The training thus
equips students in using these software tools.
Because of the nature of the work, students are
required to be computer literate with at least
some experience in working with software.
Clinical data management software tools are
called CDMS (Clinical Data Management Systems).
These systems help manage large amounts of data.
Major pharmaceutical companies use commercial
CDMS software. Some of these tools are CLINTRIAL,
RAVE, MACRO, and ORACLE CLINICAL. - There are no major differences between these
tools. However, they are quite expensive and
require a sophisticated IT infrastructure for
their functioning. Large multinational
corporations use their own custom made CDM tools.
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ent-trainings-hyderabad.php
4Clinical Data Management Tools
- However, for practice, students can use free
tools such as openCDMS, OpenClinica, etc.
Commonly, clinical data management training uses
these open source tools, especially the ones that
are most popularly in use by hospitals and
clinical trial centres in a particular area. The
software compares well in terms of functionality
with their commercial counterparts and can be
downloaded from their official websites for free. - The maintenance of data management activities
audit trail is a very important aspect of
regulatory submission studies. This audit trail
is possible through CDMS tools and can also help
identify and manage discrepancies in the data.
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ent-trainings-hyderabad.php
5Clinical Data Management Tools
- Individuals involved in a clinical research trial
have separate user IDs that give them
user-specific access to data entry, database and
quality check. Thus, multiple users have limited
functionalities that are allotted only to that
specific user. - This helps keep a track of what changes are made
at what level, which is helpful in an audit
trail. When a regulatory audit is conducted for
clinical trial data, discrepancy management can
be verified and it can be ensured that no false
changes or unauthorized alterations are made to
the data. - Clinical data management courses help students
understand these methodologies and how their
roles will vary in the organization where they
will work. Clinical data management is governed
by specific regulations, guidelines and Good
Practices that all professionals are required to
strictly adhere to.
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ent-trainings-hyderabad.php
6Ikya Global is one of the few best Clinical Data
Management training institutes in Hyderabad that
offer training at affordable prices along with
placement assistance and certification.
7For More Information about training http//www.ik
yaglobaledu.net