RGAO, RIDO and REB Requirements
For RGAO Requirements:
> Letter addressed to RGAO Cheif Coordinator (Cynthia I. Valencia, MD)
> 1 copy of complete study protocol
>1 copy of final lined-item budget of the study site
>Statement of full disclosure of past and present professional associations and business transactions with sponsors (to be assigned by the PI)
For RIDO Technical Review and UPM-REB ethics review:
A. 9 sets of Dossier ( 1 original and 8 photocopies) with the following documents ( if relevant/applicable)
(Kindly arrange the requirements in your protocol package according to the following order)
a. RIDO FORMS (Available at http://upcm.ph/?q=RIDO) or you can download it below.
Accomplished UPCM RIDO ERB F010 - Protocol Package Receipt
Accomplished UPCM RIDO ERB F011 - Request for Initial review of protocol
Accomplished UPCM RIDO ERB F014 - Ethics Review Board Ethical Review checklist
b. Curriculum Vitae of Principal Investigator and Co-Investigator/s or Supervising Investigator/s
c. GCP and/or Research Ethics training Certificates of all Investigators
d. Listed names of the study members with their brief job desvriptions
e. Protocol
f. Informed Consent Form in English
g. Informed Consent Form in Tagalog
h. Assent for Minors
i. Investigator's Brochure
j. Agreements/ Contracts
k. CDs of synopsis of the protocol containing:
> Title, PI, Department, Sponsor, primary Objective/s, brief Methodology, Number of Participants to be recruited, Study site/s, duration of the study, Inclusion and Exclusion criteria, Study diagram and flowchart, and Statistical Analysis plan.
> Informed Consent forms (English and Filipino)
> Soft Copy of the Accomplished UPCM RIDO ERB F010 - Protocol Package Receipt
B. Other Relevant documents
**Submit all the Requirements to the research Grant Administration Office (RGAO). Incomplete RGAO or RIDO and REB requirements will not be accepted.
**You may also submit the copy of the Agreements/ Contracts of the Study to RGAO upon submission of RIDO and REB Requirements to be reviewed by the UP Manila Legal Office
For RGAO Requirements:
> Letter addressed to RGAO Cheif Coordinator (Cynthia I. Valencia, MD)
> 1 copy of complete study protocol
>1 copy of final lined-item budget of the study site
>Statement of full disclosure of past and present professional associations and business transactions with sponsors (to be assigned by the PI)
For RIDO Technical Review and UPM-REB ethics review:
A. 9 sets of Dossier ( 1 original and 8 photocopies) with the following documents ( if relevant/applicable)
(Kindly arrange the requirements in your protocol package according to the following order)
a. RIDO FORMS (Available at http://upcm.ph/?q=RIDO) or you can download it below.
Accomplished UPCM RIDO ERB F010 - Protocol Package Receipt
Accomplished UPCM RIDO ERB F011 - Request for Initial review of protocol
Accomplished UPCM RIDO ERB F014 - Ethics Review Board Ethical Review checklist
b. Curriculum Vitae of Principal Investigator and Co-Investigator/s or Supervising Investigator/s
c. GCP and/or Research Ethics training Certificates of all Investigators
d. Listed names of the study members with their brief job desvriptions
e. Protocol
f. Informed Consent Form in English
g. Informed Consent Form in Tagalog
h. Assent for Minors
i. Investigator's Brochure
j. Agreements/ Contracts
k. CDs of synopsis of the protocol containing:
> Title, PI, Department, Sponsor, primary Objective/s, brief Methodology, Number of Participants to be recruited, Study site/s, duration of the study, Inclusion and Exclusion criteria, Study diagram and flowchart, and Statistical Analysis plan.
> Informed Consent forms (English and Filipino)
> Soft Copy of the Accomplished UPCM RIDO ERB F010 - Protocol Package Receipt
B. Other Relevant documents
**Submit all the Requirements to the research Grant Administration Office (RGAO). Incomplete RGAO or RIDO and REB requirements will not be accepted.
**You may also submit the copy of the Agreements/ Contracts of the Study to RGAO upon submission of RIDO and REB Requirements to be reviewed by the UP Manila Legal Office
upcmridoerbf010.doc | |
File Size: | 82 kb |
File Type: | doc |
upcmridoerbf011-2.doc | |
File Size: | 92 kb |
File Type: | doc |
upcmridoerbf014.doc | |
File Size: | 129 kb |
File Type: | doc |