Ordinance Governing

Paper 2

Usoole Tahqeeq wa Hayati Shumariyat

Clinical Research Methodology and Biostatistics

Clinical Research Methodology

• 
  Types of research
  

5. 
   Literary research
   
6. 
   Clinical research
   

2. 
   Phases of Clinical Trials
   

7. 
   Experimental research
   
8. 
   Observation and field studies
   

• 
  Trends and possibilities of research in Unani System
  
• 
  Research problems
  

3. 
   Definition
   
4. 
   Selection and sources of research problems
   

• 
  Hypothesis
  

3. 
   Types: Null and alternate hypothesis
   

• 
  Research designs
  

3. 
   Types of Research designs
   

• 
  Controls in research designs
  

9. 
   Selection criteria
   
10. 
    Placebo and plain control
    
11. 
    Randomization
    
12. 
    Balancing and matching
    

• 
  Factors effecting research results.
  
• 
  Tools and techniques in research
  

7. 
   Interview, questionnaire, inventories, scales
   
8. 
   Rating scales
   
9. 
   Analytical tools for experimental research – introduction.
   

• 
  Computer programmes used in research
  

20. 
    Minitab
    
21. 
    SPSS
    

• 
  Protocols for research and report writing
  

7. 
   Protocols for clinical research.
   
8. 
   Writing research report.
   
9. 
   References in research report.
   

13. 
    Books
    
14. 
    Journals
    
15. 
    Compendia
    
16. 
    Bulletins
    
17. 
    WHO Reports
    
18. 
    Internet Sites
    

• 
  Guidelines for Research
  

7. 
   WHO
   
8. 
   ICMR
   
   1. 
      Clinical Research and Trials
      

• 
  Bias in Clinical Trials
  

4. 
   Form Bias
   
5. 
   Source Bias
   
6. 
   Methods of Correcting the Bias
   

• 
  Issues and Prospects of Clinical Research in Unani Medicine
  
• 
  Regulatory and Ethical issues in clinical trials.
  

6. 
   Declaration of Helsinki
   
7. 
   Ethical principles
   
8. 
   Constituting ethical committee
   
9. 
   Informed consent
   
10. 
    Patient information sheet (Modular CRF)
    

Bio-Statistics

• 
  Scope and utility of Biostatistics
  
• 
  Descriptive Statistics
  

1. 
   Analysis of Data
   

7. 
   Data collection, tabulation and presentation of data.
   
8. 
   Measure of central tendency – Mean, Median and Mode.
   
9. 
   Measures of dispersion: Range, quatratile deviation, standard deviation.
   

1. 
   Probability
   

9. 
   Definition and laws of probability
   
10. 
    Types of probability distribution
    
11. 
    NPC and its application size
    
12. 
    Randomized samples
    

1. 
   Sampling
   

3. 
   Types and sample size
   
4. 
   Randomized sampling
   

• 
  Inferential Statistics
  

9. 
   Correlation and linear regression
   

5. 
   Karl Pearson correlation coefficient
   
6. 
   Linear regression equations.
   

10. 
    Test of significance
    

5. 
   ‘t’ test
   
6. 
   ‘z’ test.
   

11. 
    Test of variance
    

5. 
   ANOVA one way
   
6. 
   ANOVA two way X2.
   

12. 
    Non-parametric tests
    

5. 
   Median test, Mann Whitney U test.
   
6. 
   Kruskall Wallis test, Fried test.
   

• 
  Vital Statistics
  
  1. 
     Rate and Ratios
     
  2. 
     Standardization of population
     
  3. 
     Risk factors.
     

Reference Books

S. No.	Title of the book	Edition &Volume	Name of the Author	Publisher	Year of Publication
1	INSA Guidelines for care and use of animals in Research				2000.
2	Good Clinical Practices			GOI Guidelines for clinical trials on pharmaceutical products in India (www.cdsco.nic.in).
3	CPCSEA Guidelines			(www.cpcsea.org ).	2001
4	Ethical Guidelines for Biomedical research in Human subjects			ICMR New Delhi	2000.
5	ICMR –Guidelines on animal use			ICMR New Delhi	2001

Text Books

6	Medical Ethics	2^nd Edition	Francis CM	Jay Pee Brothers, New Delhi.	2004
7	Practical approach to PG Dissertation	1^st Edition.	Raveendran R and Gitanjali B.A	Jay Pee Brothers Medical Publishers pvt Ltd. New Delhi	1997