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Cnu-Rec-Forms-Margaritta Hermoso - Group
Cnu-Rec-Forms-Margaritta Hermoso - Group
INSTRUCTIONS: Please accomplish three (3) copies of this application form and attach them to the copies of the
proposal submitted for review.
A1 Project Title:
The Meaning of Learning to Students Amidst Pandemic: Modular Approach vs. Online
Learning
Date of Submission: Nov. 12, 2020 Proposed Start Date: November 16, 2020
Type of Study (Basic Research, Clinical Trial, Survey, etc.) Approximate Duration: 4 MONTHS
Educational Research (Survey)
Minimum 36.
Expected number of participants: Maximum of 50
▪
I undertake to commit and submit the ‘Continuing Review Approval Form’ on an annual basis to the
Cebu Normal University Ethics Review Committee (CNU-REC).
▪ I will ensure that changes in approved research protocols are reported promptly and are not initiated
without approval by the CNU-REC, except when necessary to eliminate apparent immediate hazards to the
participant.
▪
I will ensure that all adverse or unforeseen problems arising from the research project are reported in a timely fashion
to the CNU-REC.
▪ I will undertake to provide notification when the study is complete and if it fails to start or is abandoned.
INSTRUCTIONS: Please submit 3 (1 original + 2 double sided copies) copies of your protocol assessment form,
together with the appropriate supporting documentation.
TO THE PRINCIPAL Please indicate in the space provided below whether or not the specified
INVESTIGATOR/LEAD assessment point is addressed by your study protocol. To facilitate the
RESEARCHER: evaluation of the assessment point, indicate the page and paragraph
where this information can be found.
TO THE PRIMARY REVIEWER: Please evaluate how the assessment points outlined below have been
appropriately addressed by the study protocol, as applicable by
confirming the submitted information and putting your comments in the
space provided under “REVIEWER COMMENTS.” Finalize your review by
indicating your conclusions under “RECOMMENDED ACTION” and signing
in space provided for the primary reviewer.
B1 1. SCIENTIFIC DESIGN
1.1. Objectives
Review of viability of expected output yes Page 6,
1.2. Literature review
Review of results of previous
animal/human studies showing Yes Page 4-5,
Paragraph
known risks and benefits of 3
intervention, including known
adverse drug effects, in case of drug
trials.
Page 7,
1.3. Research design Paragraph 2
Review of appropriateness of design yes
in view of objectives
1.4. Sampling design
Page 8-9,
Paragrap
Review of appropriateness of sample yes h1
Size
1.5. Sample size
Page 8-9,
Paragrap
h1
Review of computation of sample yes
size
1.6. Statistical analysis plan
Review of appropriateness of No
statistical methods used and how
participant data will be summarized
RECOMMENDED ACTION
APPROVAL
MINOR MODIFICATIONS
MAJOR MODIFICATIONS
DISAPPROVAL
JUSTIFICATION FOR RECOMMENDATION
PRIMARY REVIEWER:
___________________ ______________
Signature over printed name Date: <dd/mm/yyyy>
PANEL SECRETARY:
DR. RIVIKA C. ALDA ______________
Signature over printed name Date: <dd/mm/yyyy>
PANEL CHAIR:
DR. EMMANUEL V. HERNANI ______________
Signature over printed name Date: <dd/mm/yyyy>
AF 03-v1/SOP004/v1
INSTRUCTIONS: Please submit 3 (1 original + 2 double sided copies) copies of your protocol assessment form,
together with the appropriate supporting documentation.
TO THE PRINCIPAL Please indicate in the space provided below whether or not the specified
INVESTIGATOR/LEAD RESEARCHER: element is addressed by the Informed Consent Form (ICF). TO facilitate the
evaluation of the assessment point, indicate the page and paragraph where the
information can be found.
TO THE PRIMARY REVIEWER: Please evaluate how the elements outlined below have been appropriately
addressed by the Informed Consent Form (ICF), as applicable by confirming the
submitted information and putting your comments in the space provided under
“REVIEWER COMMENTS.” In your comments, ensure that vulnerability,
recruitment process, and process of obtaining informed consent are always
assessed in the context of the study protocol and the participant. Finalize your
review by indicating your conclusions under “RECOMMENDED ACTION” and
signing in space provided for the primary reviewer.
D1
Particulars Sources of Funds and Amount (PhP)
Source (A) Source (B) Source (C)
GRAND TOTAL
AF 05-v1/SOP004/v1
IMPORTANT: The purpose of this checklist is to provide support for CNU-ERC Secretariat conducting screening
of submission materials.
Item
No. Documents for Submission Yes No NA
BASIC REQUIREMENTS
1 CNU-REC processing fee
2 Cover Letter /
3
CNU-REC Research Protocol Application Form, duly filled and duly signed by the
Principal Investigator /
4 Protocol Review Assessment Form /
5 Compliance Checklist (approved and signed by the adviser and panel members) /
6 Informed Consent Form (ICF) Checklist /
7 Study Protocol - 3 hard copies (fastened in short paper folder) /
8 Study Protocol - soft copy sent by e-mail ([email protected]) /
9 Amendments to protocol, if any /
Participant Information Sheet & Informed Consent Form (ICFs) in English and dialect /
10
spoken and understood by research participants
11 Amendments to ICF, if any /
12 Research participants questionnaires (if applicable) /
13
Signed and dated brief current Curriculum Vitae (CV) of Principal Investigators and Co- /
Investigators
14 Document Receipt Form (one copy only) /
15 Gantt Chart (signed and endorsed by the adviser/technical review panel) /
SUPPLEMENTARY
16 Research participants recruitment procedures: advertisement, notices (if applicable) /
17 Translation of Informed Consent & Back Translation Certificate /
18 Case Record Form (for clinical research) /
19 Investigator Brochure (if applicable) /
20 Insurance Policy & Indemnity Letter (if applicable) /
21 Copy of Good Clinical Practice Training Certificate for all Investigators /
22 If ICFs is not applicable, is waiver applied for /
Clinical Trial Agreement for drug trial / Memorandum of Understanding / Copy of
23 clinical trial protocol Material Transfer Agreement (MTA), as applicable, for collaborator /
& government sponsored trials (draft if final not ready)
24 FDA marketing/manufacturing license for herbal formulations / nutraceutics /
a) Administrative sanction from the Head of the Institution in case of collaborat6ive
studies with other institutions / foreign agencies (one copy) or Memorandum of /
Understanding (as applicable)
25
b) Administrative sanction from the Head of the Institution for the samples to be sent /
to outside institution (one copy) or Material Transfer Agreement (as applicable)
26 Line Item Budget /
27 Detailed Budget Sheet /
28 Site profile /
29 Any other documents submitted
DOCUMENT RECEIPT FORM
CEBU NORMAL UNIVERSITY RESEARCH ETHICS COMMITTEE CNU-REC
IMPORTANT: The purpose of this checklist is to provide support for CNU-REC Secretariat conducting screening of
submission materials.
CNU-REC
Code: __ __ __/__ __ __ __-__ __ - _______
Type of Submission: Initial Review Continuing Review of Approved Protocols
Resubmission for re-review Renewal
Protocol Amendments Protocol Termination
Full
If an approved study, level of Exempt
initial review:
Expedited
Protocol Title:
BASIC REQUIREMENTS
1. CNU-REC processing fee
2. Cover Letter
3. CNU-REC Research Protocol Application Form, duly filled and duly signed by the
Principal Investigator
4. Protocol Review Assessment Form
5. Compliance Checklist (approved and signed by the adviser and panel members)
6. Informed Consent Form (ICF) Checklist
7. Study Protocol - 3 hard copies (fastened in short paper folder)
8. Study Protocol - soft copy sent by e-mail ([email protected])
9. Amendments to protocol, if any
10. Participant Information Sheet & Informed Consent Form (ICFs) in English and
dialect spoken and understood by research participants
11. Amendments to ICF, if any
12. Research participants questionnaires (if applicable)
13. Signed and dated brief current Curriculum Vitae (CV) of Principal Investigators and
Co-Investigators
14. Document Receipt Form (one copy only)
15. Gantt Chart (signed and endorsed by the adviser/technical review panel)
SUPPLEMENTARY
16. Research participants recruitment procedures: advertisement, notices (if
applicable)
17. Translation of Informed Consent & Back Translation Certificate
18. Case Record Form (for clinical research)
19. Investigator Brochure (if applicable)
20. Insurance Policy & Indemnity Letter (if applicable)
21. Copy of Good Clinical Practice Training Certificate for all Investigators
22. If ICFs is not applicable, is waiver applied for
Clinical Trial Agreement for drug trial / Memorandum of Understanding / Copy of
23. clinical trial protocol Material Transfer Agreement (MTA), as applicable, for
collaborator & government sponsored trials (draft if final not ready)
24. FDA marketing/manufacturing license for herbal formulations / nutraceutics
c) Administrative sanction from the Head of the Institution in case of
collaborat6ive studies with other institutions / foreign agencies (one copy) or
Memorandum of Understanding (as applicable)
25.
d) Administrative sanction from the Head of the Institution for the samples to be
sent to outside institution (one copy) or Material Transfer Agreement (as
applicable)
26. Line Item Budget
27. Detailed Budget Sheet
28. Site profile
29. Any other documents submitted
------ - - - - - -TOBEFILLEDOUTBYTHERECSECRETARIAT
COMPLETENESS Complete
OF DOCUMENT Incomplete
REMARKS
DATE RECEIVED:
RECEIVED BY:
*NOTE: Please bring this receipt with you when you visit the Office of the CNU-REC.
AF 07-v1/SOP004/v1
Project Title: The Meaning of Learning to Students Amidst Pandemic: Modular Approach vs. Online Learning
Investigator: Dhafney Gonzaga, Jaime Erlano, Jamaica Fayette Lopez, Michael Clyde S. Lepasana, and Jane Lumen
Sponsor: N/A
We, the third year students who are currently enrolled in the Bachelor of Secondary
Education Major in Science of Cebu Normal University – Main Campus is currently on the
process of conducting our thesis as a requirement for our Educational Research subject. In
connection with this, we would like to ask for your written consent to be one of our respondents
for our research paper data gathering procedure.
PROCEDURES
If you volunteer to participate in this study, you will be asked to engage in a one-on-one
interview with one of the researchers. This will be done via Google Meet, Messenger or any
other online platform of your choice. You will be answering the questions based on your
experiences and perspective. With your consent, the researcher will record the whole interview
session on an audio recording device. If you wish not to, the researcher will just take note by
hand. Feel free to tell the researcher if you are not comfortable, as well as the things that you
wish not to include in this study. The one-on-one interview will take 15-20 minutes at most or it
will be up to you.
Costs
There is no cost at all, except for the time and effort required to participate in the data
gathering procedures.
CONFIDENTIALITY
We, the researcher will make sure that all records are keep confidential including your
name, your name, and response to the said study. The collected information/data will only be
available to the researcher who are responsible in conducting the study. If the result of this
study will published, the data will be released in table form and the name of the individual
participants will not be mentioned. The digitally recorded audio-video files will be stored in the
computer of the researcher with security password housed in her residence. Only the principal
investigator will have access to the file. The files will be deleted once the research paper will be
published in a journal.
IDENTIFICATION OF INVESTIGATORS
If you have any query or concerns about this research, you may ask questions to this
contact information [email protected] or you may reach the mobile number
09430579323.