1.

Full Title of Study:

2.1 Name & signatures of the
candidate

2.2 Department
2.3 Degree/course Faculty IGIMS- College of Nursing
2.4 Batch of admission to course Not Applicable
2.5 Month & year of submission of
thesis
3. Name of Faculty & Department Signatures (Principle Investigator / Co-investigator)
(Guide/Co-guide) Principle Investigator
Co-Investigator:

4. Objectives of the study

5. Why this study is required?

Please provide brief justification.

6. Methodology 6.1. Number of sample :-

6.2. Inclusion criteria:
6.3. Exclusion criteria: -
6.4.Control(s): Not Applicable
6.5. Study design- Quantitative Non- experimental descriptive research design.
6.6.Dosages of drug: Not Applicable
6.7.Duration of study: 1 year
6.8.Investigation specifically related to projects: Not Applicable
6.9 Permission to use copyrighted Questionnaire/preformed: Not Applicable
6.11 Brief methodology: -
1. Research approach Descriptive study will be adopted for the study with the aim to determine the knowledge
regarding management of common behavioural problems of school children among primary school teachers.

Research design Quantitative non-experimental descriptive research design.

2. Selection of the field for study Selected educational institutions of Patna.
3. Sample size 300
4. Assumption-
*
5. Population- School teachers, Patna
6. Sample technique Simple random Sampling technique.
7. Tool Self structured knowledge assessment questionnaire.
8. Content validity of tool- It will be determined by nursing and medical experts.
9. Try out of the tool It will be carried out 4-5 Teachers.
10. Reliability of tools It will be confirmed with Split Half Technique using Spearman-Brown prophecy formula.
11. Ethical consideration; -
* Written permission will be obtained from ethical research committee.

6. Permission from Drug Controller
General of India (DCGI)
8. Permission from DGFT, if
required
9. Safety measures for Proposed
interventions
a. Results of relevant laboratory tests
b. Result of studies in human
10. Plans to withdraw standard
therapy in research
11. Plan for provision of coverage for Not Applicable
medical risk
12. How you will maintain
confidentiality of subject?
13. Costs Involved (Appx. In Rs.)
13.1 Investigations
13.2 Disposables
13.3 Implants
13.4 Drugs / Contrast Media
Who will bear the costs of the
requirements? (mark )
14. Participant Information Sheet
(mark if yes)
15.Participant Informed Consent
form (mark if yes)
16. Whether any work on this
Project has started or not?
17.Attached documents
(If any)
* Written permission will be obtained from Head of the Educational Institution.
* Consent will be obtained from the Primary School Teachers who are willing to participate in the study.
12. Pilot study: - It will be conducted on 1/10th sample size to find out feasibility of the study for reliability of the
tool.
13. Plan of analysis:-Analysis and interpretation of data will be done according to objectives by using descriptive
and inferential statistics such as mean standard deviation and chi square.
Discussion: - it will be based on statistical analysis, current trends & previously related to research.
Conclusion: - It will be based on the research findings of the study.
1. Required 2. Not required
3. Received 4. Applied when:
1. Required 2. Not required
3. Received 4. Applied when:
a) Not an intervention study
b) No lab test for study
c) Not applicable
Yes No
Remarks: Not Applicable Not An Interventional Study.
Research data will be kept in locked almirah.
Coding will be done.
Identify containing face sheet will be removed after collecting data.
13. Self Financed (Rs. 20000/-)
13.1____No Investigation For Study___________________
13.2_____Not Applicable ___________________________
13.3______Not Applicable__________________________
13.4______ Not Applicable _________________________
1. Patient 2. Project 3. Exempted 4. Other 5. Agency
6. Researcher
Attached English version
Attached Hindi version
Certified that Hindi version is a true translation of English version
Attached English version
Attached Hindi version
Certified that Hindi version is a true translation of English version
(mark if yes, X if no)
(Please enclose a separate certificate to this effect).
Not yet, only protocol preparation for IEC.
17.1. Covering letter, through proper channel. Yes
17.2. Copy of the detailed protocol is mandatory. Yes
17.3. Undertaking that the study shall be done in accordance ICMR & GCP guidelines. Yes
17.4. In case of multi centric study, IEC clearance of other centres must be provided. NA
17.5. Definite undertaking who will bear the expenditure of injury related to the project. Yes
17.6. In case an insurance cover is intended, Insurance certificate must be provided (as per ICMR
guidelines) NA
17.7. Permission as mentioned in 6.9 Not Required
17.8. Certificate/undertaking as mentioned in 16. Yes
17.9. In case of Clinical trials, proof of registration of Clinical trial with ICMR needs to be submitted. Not
Required
17.10. Investigator should provide undertaking what they will do with the leftover sample tissue. Not Required
17.11. Soft Copy on CD: Not required
 17.12. Others:

REFERENCES

1. Asutosh,project on child care, 7 Aug 2016.

Available from: https://www.scribd.com/document/275559711/projest-on-child-care.
2. Stig brostorm, communication & continuity in the transition from kindergarten to school in Denmark, Aug-29 to 1 Sep 2000.
Available from :https://extranet.education.unimelb.edu.au/LED/tec/pdf/brostrom.pdf
3. Jhecka, common behaviour problem encountered by ECED children,7 Dec 2010
Available form :http://jhecka12.blogspot.com/2010/12/problem-checklist-eced-13.html
4. Garg, Pandey, Effectiveness of Standard Teaching Programme on selected common behavioural problems of children, IOSR Journal of Nursing
& Health science volume 3, Issue 6 Ver. I (Nov.-Dec.2014), PP 08-12 Available from : www.iosrjournal.org
 CERTIFICATE

1. This is to certify that the research study --------------------------------------------------------------

will be done as per ICMR/GCP guideline.

2. This is further certified that the expenditure will be borne by researcher for conducting
research study for stationary and other miscellaneous.

Signature of Principal Investigator: Signature of Co-Investigator:

To
The Chairman,
Sub Ethics -Committee
IGIMS-CON, IGIMS PATNA-14

Topic- Regarding submission of research proposal for ethical clearance

Through- Proper Channel

Sir,
We undersigned hereby submitting the research title, ---------------------------------------------------
----------------- for ethical clearance and approval.

We would request you to kindly look into the matter and do the needful.

Thanking You

Yours Sincerely

Signature of Principal Investigator: Signature of Co-Investigator:

 DECLARATION

We have read and agreed to comply with the procedures details in this document.
All the relevant standard procedures will be adopted to conduct this study with the highest
ethical standards. We have read Helsinki Declaration (for clinical studies), ICP-GCP guideline
/CPCSEA guidelines/ ICMR ethical guidelines and other applicable guidelines and undertake to
follow them strictly in performance of this study. The study will be performed as per approved
grant of permission for study. Permission will be obtained immediately from ethical committee
for any deviations, if occurred during study. The study will be terminated immediately in case of
any unforeseen adverse consequences and ethical committee will be informed immediately.

Date: 27/06/17

Signature of Principal Investigator: Signature of Co-Investigator: