ERB FORM 4 ERB Ethical Review Checklist
Republic of the Philippines
CAVITE STATE UNIVERSITY
Don Severino de las Alas Campus
Indang, Cavite
' (046) 862-0939 / 862-0940 www.cvsu.edu.ph CvSU ERB Form 04. Ethics Review Board Ethical Review Checklist
TITLE:
PROPONENT/INVESTIGATOR:
Co - Investigators/Co-Researchers:
Sponsor:
For the Principal Investigator/Proponent:
This checklist has been prepared to ensure that the protocol submission complies with GCP standards.
Please review the checklist carefully.
In the 2nd column, please indicate the page in the protocol where the item (if applicable to your study) can be found.
Write N/A if not applicable.
Write your other remarks in the column.
For the Reviewer:
In the 3rd column, please write your remarks.
Indicate if item is: adequately addressed (√) not applicable (n/a)
If the item is not adequately addressed – please write your remarks regarding the issue which P.I needs to address.
REVIEW of the PROTOCOL
I. Review of the Technical Soundness of the Protocol
To be filled up by Principal Investigator/Proponents
N/A
Remarks by Reviewer
Page/Paragraph No. and PI’s/Proponents remarks
1. Were potential conflicts of interest between the Principal Investigator (PI) /Proponents and the participant disclosed and addressed?
2. Has a scientific/technical review been done by a research advisory committee?
3. Has the protocol been submitted to/approved by an ERB elsewhere?
a. If yes, please submit the result of the ERB review elsewhere with the documents for your present application.
4. Is there a section on ethical concerns in the protocol? a. Are possible ethical issues identified? [gender, culture, equity (fairness in treating people without prejudice1)]
b. Is the informed consent process clearly described?
5. Is the investigator/roponent qualified to undertake the study?
a. Please submit updated CV of investigator (s) and research staff
b. If applicable, please submit certified true copy of GCP training
CAVITE STATE UNIVERSITY
Don Severino de las Alas Campus
Indang, Cavite
' (046) 862-0939 / 862-0940 www.cvsu.edu.ph CvSU ERB Form 04. Ethics Review Board Ethical Review Checklist
TITLE:
PROPONENT/INVESTIGATOR:
Co - Investigators/Co-Researchers:
Sponsor:
For the Principal Investigator/Proponent:
This checklist has been prepared to ensure that the protocol submission complies with GCP standards.
Please review the checklist carefully.
In the 2nd column, please indicate the page in the protocol where the item (if applicable to your study) can be found.
Write N/A if not applicable.
Write your other remarks in the column.
For the Reviewer:
In the 3rd column, please write your remarks.
Indicate if item is: adequately addressed (√) not applicable (n/a)
If the item is not adequately addressed – please write your remarks regarding the issue which P.I needs to address.
REVIEW of the PROTOCOL
I. Review of the Technical Soundness of the Protocol
To be filled up by Principal Investigator/Proponents
N/A
Remarks by Reviewer
Page/Paragraph No. and PI’s/Proponents remarks
1. Were potential conflicts of interest between the Principal Investigator (PI) /Proponents and the participant disclosed and addressed?
2. Has a scientific/technical review been done by a research advisory committee?
3. Has the protocol been submitted to/approved by an ERB elsewhere?
a. If yes, please submit the result of the ERB review elsewhere with the documents for your present application.
4. Is there a section on ethical concerns in the protocol? a. Are possible ethical issues identified? [gender, culture, equity (fairness in treating people without prejudice1)]
b. Is the informed consent process clearly described?
5. Is the investigator/roponent qualified to undertake the study?
a. Please submit updated CV of investigator (s) and research staff
b. If applicable, please submit certified true copy of GCP training