Data management functions in clinical trials—extensive data cleaning, full query management, protocol deviation management, batch processing, as examples—have traditionally been served by stand-alone clinical data management systems (CDMS), whose input is from paper forms or from separate electronic data capture systems. Distinct electronic data capture and data management systems require data integration, with resulting timing and reconciliation issues.

1. Clinical Research and Clinical Data
Management
Everything You Need to Know
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2. 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.
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3. 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.
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4. 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 long-term use.
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5. 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.
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6. 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.
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7. 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 the
end of the study like betterment in the disease or disorder in the group
that is experimented can be ascribed to the experimental drug.
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8. 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 managed in the clinical trials.
http://www.ikyaglobaledu.net/Clinical-research-trainings-hyderabad.php

9. 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 the data variance.
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10. 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

11. 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 managed in the clinical trials.
http://www.ikyaglobaledu.net/Clinical-research-trainings-hyderabad.php

12. Ikyaglobal.edu is one of the leaders in training people in Clinical Data
Management and making them industry-ready.
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