How to research protocol and what is the checklist to cover standard protocol

1. SYNOPSIS WRITING PROTOCOL
22 & 23 May 2021
Dr.Anjali Upadhye

2. www.statsanjal.in

3. Health Science Evaluation Checklist
Sr.no Item Component Yes No NA
10
Title 1.Clear & Brief
PICO 2.Important Variables mentioned
3.Patients/Participant
4.Intervention
5.Comparator
6.Outcome
7.Reflects the Study Design
8.Reflects Primary Objective
9.Includes Target Population
10.Whether the title /study has been
repeated

4. Exmples of DIFFERENT STUDY DESIGNS
4
• Open/Parallel
• Phase i/Phase II/Phase III
• Comparative
• A Case Control/ Cross over/
• Random clinical trials
• Observational
• A survey study
• Experimental
• OPEN BLINDED/DOUBLE BLINDED etc…..

5. Health Science Evaluation Checklist
SR.NO ITEM COMPONENT YES NO NA
11 Research
Question
1. Feasible
FINER 2.Interesting
3.NOVEL
4.ETHICAL
5.Relavant
6.Socially Relevant

6. Health Science Evaluation Checklist
SR.NO ITEM COMPONENT YES NO NA
12 Hypothesis 1. Clearly Stated
2. Reflects the relation of
two or more variables
3.Independent Variable
4.Dependent variable
5.Relavant

7. Health Science Evaluation Checklist
SR.NO ITEM COMPONENT YES NO N
A
13 Introduction 1. Rationale of the study
2. Relevant Epidemiological
Data
3.Solution to bridge
knowledge Gap
4.Prevalance of study
5.Review of concerned
study

8. Health Science Evaluation Checklist
SR.NO ITEM COMPONENT YES NO N
A
14 Review of
Literature
1. Includes recent/ongoing
research relevant to the
present studyRationale of
the study
2. Present knowledge Gap
for stated problem
3.Justifies the research
question
4.Minimum 15 references
from the following sources
Textbook, Govt Reports,
Classical Texts, reference
books, Journals, database,
websites

9. Health Science Evaluation Checklist
SR.NO ITEM COMPONENT YES NO N
A
15 Objectives 1. Primary
2. Secondary
3.Describes End Points
4. SMART
S: target specific area of
improvement
M: Measurable
A :assignable ,who will do it
,Achievable
R: Realistic
T :Time Related bounded

10. Bloom’s Texanomy …
10
Level Description
1. Knowledge Recognize facts, terms, and principles
2. Comprehension Explain or summarize in one’s own words
3. Application Relate previously learned material to new
situations
4. Analysis Understand organizational structure of material;
draw comparisons and relationships between
elements
5. Synthesis Combine elements to form a new original entity
6. Evaluation Make judgments about the extent to which
material satisfies criteria
Less
complex
More
complex

11. 11
Bloom’s Level Verbs
1. Knowledge match, recognize, select, compute, define, label,
name, describe
2. Comprehension restate, elaborate, identify, explain, paraphrase,
summarize
3. Application give examples, apply, solve problems using, predict,
demonstrate
4. Analysis outline, draw a diagram, illustrate, discriminate,
subdivide
5. Synthesis compare, contrast, organize, generate, design,
formulate
6. Evaluation support, interpret, criticize, judge, critique, appraise

12. Health Science Evaluation Checklist
SR.NO ITEM COMPONENT YES NO N
A
16 Methodology 1. Type of Study Design
2. Setting –location
3. Duration of the study
4.Methods of selection of study
subject
a. Inclusion Criteria
b. Exclusion Criteria
c. Withdrawal Criteria
5.Methods of Comparision
6.Operational Defination
7.Matching Criteria
8.Specification of Instruments

13. Health Science Evaluation Checklist
SR.NO. ITEM COMPONENT YES NO N
A
17 Research
Methodology
Specified
1. Sample Size Calculation
Data
Collection
2. Sampling techniques
3. Data Collection related to
objectives
4.Study Instrument –data
collection tool like case studies
,questionnaire
5.Data Management -Coding
6.Plan of Statistical Analysis

14. Health Science Evaluation Checklist
SR.NO ITEM COMPONENT YES NO N
A
18 Referencing
Style
1. VANCOUVER
BIBILOGRAPHY 2.In case of Sholka USE JAIM
format
3. Go for British library website
where u find Vancouver
generator
4. MSWORD 2010 Version has
inbuilt VANCOUVER version
5. In proposal …as per refrence
of numbering
6. In dissertation
…alphabetically

15. REFERENCES
15
1. VANCOUVER style should be adopted. http://guides.lib.monash.edu/citing-
referencing/vancouver
http://www.citethisforme.com/vancouver
2. In case of shlok/samhita format of JAIM should be adopted. eferencing
Ayurvedic Classics
Text from a classic:
Sharma S, editor, (1st ed.). Ashtanga Samgraha of Vagbhata, Sootra Sthana;
Dravadravya Vidnyaniya: Chapter 6, Verse 10-16. Varanasi: Chowkhambha
Sanskrit Series, 2006; 37-38.
Verse /Text in a commentary on classic: Sharma S, editor, (1st ed.). Commentary
Shashilekha of Indu on Ashtanga Samgraha of Vagbhata, Sootra Sthana;
Dravadravya Vidnyaniya: Chapter 6, Verse 10-16. Varanasi: Chowkhambha
Sanskrit Series, 2006; 37-38.

16. Health Science Evaluation Checklist
SR.
NO
ITEM COMPONENT YES NO N
A
19 Annexures 1. Case record form
2. Questionnaire/Performa
3. Informed Consent form including
vernacular language
4. Abbreviations validated and authentic
5.Parameters of Assessment of study
outcomes
6.Authentic documentation of resources
7.APPENDIX A (Title submission letter)
8.APPENDIX B (Ethical committee letter
9. Certificate of RMMS workshop by
MUHS

17. Health Science Evaluation Checklist
SR.
NO
ITEM COMPONENT YES NO N
A
20 Concluding
Remarks
1. Accepted
2. Accepted with Modifications
3. Rejected
21 Modifications
Suggested
1
2
3
4
5

18. -
• Literary Review regarding drug
• Ancient and Modern-conceptual study
• Pharmaceutical Preparation,
• Analytical- Instruments and methods used
for analysis
SYNOPSIS SKELETON FOR ANALYTICAL STUDY

19. SYNOPSIS SKELETON FOR CLINICAL STUDY
Hypothesis (Research Question) : What are
important variables involved in your study:
(This section is also very important)
Dependent variables,
Independent variable,
Extraneous variable :
Null Hypothesis (HO)
Alternate Hypothesis (HR)

20. Materials and Methods -
• conceptual study – disease and drug review
with mode of action (Literary Review)
• Pharmaceutical study – Drug manufacturing •
Analytical study- drug standardization
• Clinical study- • Inclusion criteria
• Grouping and randomization of patient
• Drug administration details
• Assessment criteria- subjective, objective
• Follow up
• Withdrawal criteria
• Overall assessment criteria

21. SYNOPSIS SKELETON FOR OBSERVATIONAL STUDY
Materials and Methods
• conceptual study (Literary Review) Method of
Actual observational study
• Research tool
• Sampling plan
• Area of sampling
Observations
(mention appropriate Statistical tests for
analysis) results
Discussion

22. SYNOPSIS SKELETON FOR EXPERIMENTAL STUDY
Materials and Methods
• conceptual study Literary Review according to
research topic
• Pharmaceutical – Preparation of study
• Analytical- Instruments and methods used for analysis
• Experimental- For In-Vivo-
• Selection of animal • Preparation of animal
• Grouping
• Details about drug administration

23. Book Publications
23

24. 172 in last 10 years
OUR PROJECTS OF PG STUDENTS
100%
Total success!
65 in last 5 years
OUR PROJECTS OF Ph.D.STUDENTS

25. WE ARE ….
1. Dr.Anjali Upadhye
M.Sc.,M.B.A., PGDTQM, ADCCAA, Ph.D.

26. Thanks!
Any questions?
You can find me at:
▪ statsanjal@gmail.com
▪ anjaliupadhye1511@gmail.com