Clinical Data Management Tools - PowerPoint PPT Presentation

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Clinical Data Management Tools

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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. – PowerPoint PPT presentation

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Title: Clinical Data Management Tools


1
Clinical Data Management Tools
For More Information Please visit
http//www.ikyaglobaledu.net/Clinical-data-manage
ment-trainings-hyderabad.php
2
Introduction
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.
http//www.ikyaglobaledu.net/Clinical-data-managem
ent-trainings-hyderabad.php
3
Clinical 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.

http//www.ikyaglobaledu.net/Clinical-data-managem
ent-trainings-hyderabad.php
4
Clinical 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.

http//www.ikyaglobaledu.net/Clinical-data-managem
ent-trainings-hyderabad.php
5
Clinical 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.

http//www.ikyaglobaledu.net/Clinical-data-managem
ent-trainings-hyderabad.php
6
Ikya 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.
7
For More Information about training http//www.ik
yaglobaledu.net
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