Clinical Research and

Clinical Data Management

Everything You Need to Know

For More Details

Visit
http://www.ikyaglobaledu.net/Clinical-research-trainings-hyderabad.php

Introduction
Clinical research is an arm of healthcare science which
decides the safety and potency of medications, devices,
diagnostic products, and the treatment regimens that are
aimed for human use. These could be utilized for the
prevention and treatment and the diagnosis or for
relieving symptoms of a disease.

Clinical research includes the clinical trials that are the

studies which assess the potency and the safety of the
medical devices or the drugs. The studies are carried on
according to a standard protocol that determines what
type of patient can take part, when and how much of the
treatment is administered, what exactly is being
calculated,
and the overall length of the study.
http://www.ikyaglobaledu.net/Clinical-research-trainings-hyderabad.php

Clinical Trial Phases

Clinical trials go ahead in stages going forward for
the use for patient care after the drug or device has
been exhaustively analyzed for potency and safety.
The stages of clinical trials that every new
treatment must clear to be launched into the
market include:

Phase I: Researchers trial run a new drug or treatment in a

small group for the first time to measure how safe it is, to
decided a safe dosage range, and distinguish the side
effects.

Phase II: The drug or treatment is now been administered

to a large group to measure its effectiveness and to
evaluate
its safety.
http://www.ikyaglobaledu.net/Clinical-research-trainings-hyderabad.php

Clinical Trial Phases

Phase III: The drug or treatment is given to large groups of
people to confirm its effectiveness, monitor side effects,
compare it to commonly used treatments, and gather
information which allows for the drug or treatment to
safely be used.

Phase IV: Studies are conducted after the drug or

treatment has been launched into the market, to collect
information on effect of the drug in different populations
and if there are any side effects associated with the longterm use.
http://www.ikyaglobaledu.net/Clinical-research-trainings-hyderabad.php

Research Designs that are Used in Clinical

Research
There are number of research blueprints that are utilized
for clinical research that include descriptive, exploratory,
and experimental studies.

Descriptive
Research:
Descriptive
research
takes
observations about patients or health-related status. This
research usually includes a small group of patients and
intense studies done on them to get an idea about the
content of interest. Case-studies and qualitative research
and surveys are some of the examples.
http://www.ikyaglobaledu.net/Clinical-research-trainings-hyderabad.php

Research Designs that are Used in Clinical

Research
Exploratory Research: Exploratory research examines
analyses the patients or the conditions which have not
been largely examined. Exploratory research works to
clear up or determine a problem. Many a times,
associations or relationships are sought for so as to get a
better understanding of the disease or the disorder. For
example, a study may disclose the relationship between
the lifestyle components and the particular disease. Some
of the examples are case-control studies, cohort studies,
pilot studies, and historical research.
http://www.ikyaglobaledu.net/Clinical-research-trainings-hyderabad.php

Research Designs that are Used in Clinical

Research
Experimental Research: Experimental research calls for
equating two groups of people. In general, one of the
groups gets an intervention or treatment whereas the
other group does not. The intent of this research is to
probe the effect of the treatment. When randomisation is
used, these designs, are seen as the "gold standard" in
clinical research because this design lets the researchers
to rule out most or maybe even all of the alternative
explanations in regard to the results. For instance, a
researcher may equate a group of patients getting a
placebo drug versus a group that is getting an
experimental drug. The two groups could be the same at
the beginning of the study. The differences that occur at
http://www.ikyaglobaledu.net/Clinical-research-trainings-hyderabad.php
the end of the study like betterment in the disease or

Research Designs that are Used in Clinical

Research
The main intent of clinical trial is to get answers to the
research question by ways of getting data that proves of
disapproves hypothesis. The data quality that is generated
has an important part in the result of the study. Many a
time, students who do research as heard asking questions
such as, what is clinical data management and what is its
significance? Clinical data management is a needed and
significant component of a clinical trial. All the researchers
attempt their work on CDM actions during their research
work, whether knowingly or unknowingly. Apart from the
technical areas, the process is undertaken that involves
CDM during the research work. The actions that are
involved
in CDM gives the gist of the way data is been
http://www.ikyaglobaledu.net/Clinical-research-trainings-hyderabad.php
managed in the clinical trials.

Research Designs that are Used in Clinical

Research
Clinical data management [CDM] can be explained as the
process of the collection and the cleaning and the
management of the subject data in agreement with the
regulatory standards. The main aim of CDM operation is to
give high-quality information by maintaining the number
of the errors and the missing data as low as possible and
also gathering the maximum data for analysis. In order to
achieve this aim, the best practices are taken to make
sure that the data are complete and reliable and
processed correctly. This has been made to happen with
the assistance of software applications which maintain the
audit trail and that provide easy recognition and answer of
thehttp://www.ikyaglobaledu.net/Clinical-research-trainings-hyderabad.php
data variance.

Research Designs that are Used in Clinical

Research
High-quality data can be defined as perfectly precise and
suited for the statistical analysis. Specific protocol
parameters should be met and protocol requirements
should be complied with. This means that if there is a case
of difference, when the protocol specifications are not
met, then there is a possibility of taking the patient out
from the final database. It should also be kept in mind that
in certain situation the regulatory authorities would be
interested into seeing this data. Also, it should be noted
that the data that is missing could be a cause of concern
for the clinical researchers. In high-quality data there
should be minimal or no misses at all.
http://www.ikyaglobaledu.net/Clinical-research-trainings-hyderabad.php

Research Designs that are Used in Clinical

Research
The main intent of clinical trial is to get answers to the
research question by ways of getting data that proves of
disapproves hypothesis. The data quality that is generated
has an important part in the result of the study. Many a
time, students who do research as heard asking questions
such as, what is clinical data management and what is its
significance? Clinical data management is a needed and
significant component of a clinical trial. All the researchers
attempt their work on CDM actions during their research
work, whether knowingly or unknowingly. Apart from the
technical areas, the process is undertaken that involves
CDM during the research work. The actions that are
involved
in CDM gives the gist of the way data is been
http://www.ikyaglobaledu.net/Clinical-research-trainings-hyderabad.php
managed in the clinical trials.

Ikyaglobal.edu is one of the leaders in training people in

Clinical Data Management and making them industry-ready.

http://www.ikyaglobaledu.net/Clinical-research-trainings-hyderabad.php

http://www.ikyaglobaledu.net/Clinical-research-trainings-hyderabad.php