Download Pharm D 5th Year 2015 April 383825 Clinical Research Question Paper

FirstRanker.com

[LG 825] APRIL 2015 Sub. Code: 3825

DOCTOR OF PHARMACY (PHARM. D/ POST BACCALAUREATE) DEGREE EXAMINATION

--- Content provided by​ FirstRanker.com ---

(2009-2010 Regulation)

FIFTH YEAR

PAPER I - CLINICAL RESEARCH

Q.P. Code: 383825

Time: Three Hours Maximum: 70 marks

--- Content provided by​ FirstRanker.com ---

Answer All questions

1. Elaborate on: (4 x 10 = 40)
   1. Double blind clinical trials.
   2. Open label clinical trials.
   3. Retrospective studies.

--- Content provided by‍ FirstRanker.com ---

2. What is meant by informed consent? Explain content and method of administration of informed consent as per regulatory authorities in clinical trials.
3. What are dosage forms? Give example. Explain different types of dosage forms.
4. Explain the protocols and method of reporting ADR under Pharmacovigilance.

2. Write notes on: (6 x 5 = 30)
   1. How SOPs are prepared to meet the GLP standards?
   2. Write the ethical consideration in the conduct of clinical trials.

   --- Content provided by​ FirstRanker.com ---

   3. Write a note on safety monitoring in clinical trials.
   4. What are the major challenges observed in implementation of the regulatory guidelines in clinical trials?
   5. Briefly write the data management in clinical trials.
   6. Explain:
      1. Placebo.
      2. Human Subjects.

      --- Content provided by‌ FirstRanker.com ---

      3. Candidate drug.