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National Institute of Business
Management
Chennai - 020
EMBA/
MBA
Elective: CLINICAL RESEARCH
MANAGEMENT ELECTIVE PART - 2
Attend
any 4 questions. Each question carries
25 marks
(Each answer should be of minimum 2 pages /
of 300 words)
1.
Explain
the reasons for ineffective planning of a clinical trial.
Answer :
failures in clinical research usually occur
in two dimensions:
- Project failure, e.g. the budget has been overspent, project
targets haven’t been achieved and deadlines haven’t been met.
- Research failure, e.g. not being able to reach statistical
significance in a research area and so failed to prove the efficacy
of a drug or obtain controversial results.
1.
Unskilled Project Manager
2. Drug development encompasses stages
such as formulation, toxicology and trials. Explain.
Answer : Any drug development process must proceed through several
stages in order to produce a product that is safe, efficacious, and has passed
all regulatory requirements.
PRODUCT CHARACTERIZATION
When
the candidate molecule shows promise as a therapeutic, it must be
characterized—the molecule’s size, shape, strengths and weaknesses, preferred
conditions for maintaining function, toxicity, bioactivity, and bioavailability
must be determined. Characterization studies will undergo analytical method development and validation.
Early stage pharmacology studies help to characterize the underlying mechanism
of action of the compound.
FORMULATION, DELIVERY, PACKAGING DEVELOPMENT
Drug
developers must devise a formulation that ensures the proper drug delivery
parameters. It is critical to begin looking ahead to clinical trials at this
phase of the drug development process. Drug formulation and delivery may
3. Discuss clinical data management
system (CDMS).
Answer : Clinical data management (CDM) is the process of
collecting and managing research data in accordance with regulatory standards
to obtain quality information that is complete and error-free. The goal is to
gather as much of such data for analysis as possible that adheres to federal,
state, and local regulations.
The
field of clinical data management (CDM) has come about due to demands from both
the pharmaceutical industry and the regulatory authorities. As the drive to
“fast-track” the development of pharmaceutical
4. Explain the need for alternative
methods of clinical trial for Ayurveda medicines.
Answer :
5. Case
Report Form (CRF) is a trial document for collecting and recording patient
related information in a standardized and uniform manner. This is important for
the clinical trial team because the analysis and reporting of trial outcome is
largely based on the completeness and accuracy of data recorded from each
patient recruited in the trial. Explain.
Answer :
6. Describe fraud and misconduct in
clinical research.
Answer : Fraud and misconduct in clinical
research is widespread. Good clinical practice is a guideline adopted
internationally as standard operating procedure for conduct of clinical
research. Despite these guidelines being available, unavailability of
internationally harmonized framework for managing research fraud and misconduct
makes clinical research a highly vulnerable area to commit fraud. Fraud could
be of various types and due to various reasons. Whatever the circumstances be,
any fraud should be dealt with strictly and regulations should be in place to
prevent its occurrence.
Dear students, get fully solved assignments by
professionals
Do send your query at :
or call us at :08263069601
25
x 4=100 marks
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