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Clinical
Research Management
1. Explain the steps involved in “Designing
Clinical Trials?”
2. Explain in detail Responsibilities of
CRC(Clinical Research Coordinator) and
CRA(Clinical Research Associate)?
3. Explain in your words the “Ethical
issues in patient recruitment”?
4. Explain in detail different types of
audits involved in Clinical Trials?
1.
How
can Dr. Brown or Dr. Jones find an appropriate clinical trial for Mr. Smith?
2.
What arguments can be put forward in favor of
paying people for participating in clinical trials?
3.
How convincing is the view that the market
should decide how much subjects should be paid? That is, should people be
offered as much as is necessary for them to agree to participate, or is there
something about research that makes another standard of payment appropriate?
4.
How convincing is the notion that participation
in clinical trials is like low-skill work and therefore worthy only of a
minimum wage?
5.
The goal of Federal Regulations is to protect
research subjects. Do you believe that the original regulations took an
appropriate approach to protecting fertile females, pregnant women, and fetuses
from research risk? What was the effect of this approach?
6.
The new regulation permits but does not require
inclusion of pregnant women in clinical research. Do you believe that
pharmaceutical manufacturers will be interested in increasing studies in
pregnant women? What are the incentives? What are the obstacles?
7.
Fear of legal liability leads researchers and
sponsors to guard against participation of pregnant women in clinical research.
Do you think that mechanisms to address this fear would work to increase the
role of women in clinical studies? Such mechanisms include, for example, caps
on the liability sponsors would face, creation of a federal fund to compensate
harmed subjects, and building liability costs into the costs of doing business.
Should one or more of these mechanisms be put in place to increase involvement
of pregnant women in clinical trials?
CLINICAL PHARMACOLOGY
CASE STUDY: 1
Questions:-
Q.1) What are the
important responsibilities of Mr. Kate?
Q.2) What are the
different stages Mr. Kate will use in the Process to set up the project and run
it?
Q.3) On what
elements will Mr. Kate focus?
Q.4) What are
your Suggestions?
CASE STUDY: 2
Questions:-
Q.1) What is a clinical
trial?
Q.2) What is the
process of designing and carrying out clinical research?
Q.3) Explain the
Planning Steps of Mr. Simpson.
Q.4) What are the
important considerations to conduct of any type of clinical trial?
CASE STUDY: 3
Questions:-
Q.1) Define CRC
Q.2) Define CRA
Q.3) Who can be
appointed as a CRC/CRA?
Q.4) Elaborate
the responsibilities of the CRC and CRA?
CASE STUDY: 4
Questions:-
Q.1) What is the
definition of fraud and misconduct in clinical research?
Q.2) According to
you what are the steps and procedures adopted by Mr. Kunte to
investigate
fraud?
Q.3) What are the
penalties you can suggest to Dr. Kunte for proven fraud and
misconduct?
Q.4) Explain the
responsibilities of Dr. Kunte as an investigator in the Whole process.
Clinical Research
1. While understanding headache what are the sensitive to mechanical
stimulations? Explain Migraine & Tension headaches. State the Limitations
of symptoms?
2. What are the reasons of the use of animals for clinical research? How the
Guinea Pigs, Mice & albino rats, the hamster, rabbits & dogs are useful
in clinical research?
3. What are the purpose of Laboratory tests carried out or employ by a
clinicians?
4. What are the diagnostic errors? State the role or ancillary examinations?
5. How are new therapies introduced? What are the objectives of therapy?
6. Write as short note on : ( Any 2 ) Mammography Electronic Foetal Monitoring Tonsillectomy
7. In obtaining a medical history from a patient the clinician should posses
some qualities. Explain them in details.
8. Human Nutrition needs or essential minerals name them & explain the
importance of each?
Clinical
Research Management
1. Write a note on various phases of clinical trials
2. Explain patient inclusion and exclusion criteria in
relation to clinical research protocol.
3. Define randomization and explain different methods of
randomization.
4. Write a note on following documents in a clinical study-
(i) Investigator’s
brochure (IB)
(ii) Case report form (CRF)
5. Write a short note on Schedule Y of clinical research.
6. Describe the general measures taken in an event of
clinical drug toxicity.
7. Write a short note on- Termination of Investigational New
Drug Application (IND)
8. What is clinical hold? Describe grounds for imposition of
clinical hold under IND.
WE PROVIDE CASE STUDY
ANSWERS, ASSIGNMENT
SOLUTIONS, PROJECT REPORTS AND THESIS
ARAVIND - 09901366442 – 09902787224
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