Clinical Data Management Training in Hyderabad - Ikyaglobaledu

1
Clinical Research and Clinical Data Management
2
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.
3
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.
4
Clinical Trial PhasesClinical trials go ahead
in stages going forward for the use for patient
care after the drug or device has been
exhaustively analysed for potency and safety. The
stages of clinical trials that every new
treatment must clear to be launched into the
market includePhase 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.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.
5
The 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.
6
Exploratory ResearchExploratory 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.
7
Experimental ResearchExperimental 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.
8
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.
9
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.
10
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. It is very important that the
high-quality data should have only an
discretional level of variation that is
acceptable and this should not impact the end of
the study on the statistical analysis. Also, the
data should comply with the applicable regulatory
needs that are specified for data quality.
11
Ikyaglobal.edu is one of the leaders in training
people in Clinical Data Management and making
them industry-ready.