Submission Process

Please read through each items carefully to assist you with the process for initial submission (via iREB) to the UP Manila Research Ethics Board (UPMREB):

1. Register study with RGAO (Research Grants Administration Office) at http://rgao.upm.edu.ph/registration

You will need the RGAO reference number in your iREB application. A registration certificate with RGAO reference number will be sent to you via email after 1-2 working days. You may also reach them at rgao.upm@up.edu.ph for inquiries on ethics fees, clinical trial agreements, and opportunities for funding (as applicable).

2. Request for an iREB account at https://ireb.upm.edu.ph/account/request and use your UP ADS account

You can do this while waiting for the RGAO reference code. After registration, UPMREB Secretariat will assess the request after 1-2 working days and forward this to IMS if there are no ADS accounts yet. Once approved, you can access iREB using your UP ADS account (iREB username will be your UP email, without '@up.edu.ph', and the password will be the same one used in the UP email). If the Principal Investigator does not have an official UP email/account, he/she can request through the iREB website.

If no UP ADS account yet, please wait for the IMS to notify you regarding creation of ADS credential. To request for ADS password reset, please email ads-admins@post.upm.edu.ph with the subject "Request for ADS Password Reset".

3. Log in to iREB at https://ireb.upm.edu.ph/login, complete the online forms and upload all the required documents in PDF format.

Upload applicable documents in their respective fields. Merge all CVs in one pdf file, and all GCPs in another pdf file. You can explore online tools such as ilovepdf.com for merging files. Upload a signed UPMREB Form 2B (e.g. signature fields on item 28, Section II, Section III, Section IV as applicable, and Section V), in the "Others" field.

You may refer to our website at http://reb.upm.edu.ph/ for detailed information on the submission process, cut-off dates, review status, etc. Updated versions of UPMREB forms are downloadable at http://reb.upm.edu.ph/sops-and-forms (see SOP II).

4. Wait for UPMREB's notification regarding acceptance of iREB application

UPMREB will screen your submission. You will be notified through email once documents will be received, or if you need to address screening issues. Please take note that iREB sends you an email using a 'no-reply' email address. For any concerns, you can reach us at upmreb@post.upm.edu.ph.

5. Submit four (4) complete sets of printed copies of the required forms and basic documents to UPMREB at Room 126, NIH Bldg., UP Manila.

Instructions for Other Type of Submissions
General Instructions:

1. Download the required UPMREB form at http://reb.upm.edu.ph/sops-and-forms.

2. Submit your application and corresponding attachments to upmreb@post.upm.edu.ph using the following subject heading: ___

3. Wait for an email notification from UPMREB to submit the hard copies of your documents.

4. Submit four (4) complete sets of hard copy of accomplished UPMREB form and related document(s) to UPMREB office at Rm 126, NIH Bldg, UP Manila (temporarily lifted).

Resubmission
1. Summarize the revisions vis-a-vis the panel recommendations in a cover letter addressed to the Panel Chair indicating in which page of the revised study protocol the respective revision may
be found;
2. Integrate the requested revisions into a revised STUDY PROTOCOL/PACKAGE and UPMREB FORM2(B)2012 APPLICATION FORM, with the revisions underlined and bold-faced;
3. Write the panel recommendations in the first column of the UPMREB FORM 2(H)2012: REVIEW OF
RESUBMITTED REVIEW FORM, and the second column only with a number outline corresponding the
recommendations (e.g. 1.1, 1.2, 1.3, ..). This column will be filled out by the reviewer.
4. Ensure that the version number and date are indicated in the revised protocol and other revised protocol-related files.
5. Submit the resubmission package via email with the following subject: Type of submission_Last name_Code_Panel (Ex: Resubmission_Dela Cruz_UPMREB 2020-001-01_Panel 1)
6. Please note that resubmissions can only be accepted within 90 days from the date of the decision letter. Failure to respond within 90 days from the date of the letter will inactivate the application and study protocol will be archived. Subsequent submissions will be processed as an initial review.

Study Protocol Amendment
1. Accomplish UPMREB Form 3(A)2012: Study Protocol Amendment Submission Form completely and accurately (e.g. Study Protocol Title, Study Protocol Approval Date)
2. Specify the type of amendment, section in the protocol, and justification for the change/s
3. If there are changes in the approved protocol and documents, ensure to update version number and date
4. Submit a signed Form 3A, and a version in word form (to be accomplished by the reviewers)
5. Submit the amendment package via email with the following subject: Type of submission_Last name_Code_Panel (Ex: Amendment_Dela Cruz_UPMREB 2020-001-01_Panel 2)
6. Ensure that the study has a valid ethical clearance prior to submission of any subsequent applications.

Continuing Review Application
1. Accomplish UPMREB Form 3(B)2012: Continuing Review Application Form completely and accurately (e.g. Study Protocol Title, Study Protocol Approval Date)
2. List only reports (e.g. amendments, deviations) that were processed and approved prior to submission of the continuing review application
3. Attach the protocol synopsis and copy of the latest approved ICF (as applicable)
4. Submit a signed Form 3B, and a version in word form (to be accomplished by the reviewers)
5. Submit the package via email with the following subject: Type of submission_Last name_Code_Panel (Ex: CRA_Dela Cruz_UPMREB 2020-001-01_Panel 3)
6. We advise to submit the continuing review application form at least 30 days prior to expiry date of the ethical clearance.

Final Report Form
1. Accomplish UPMREB Form 3(C)2012: Final Report Form completely and accurately (e.g. Study Protocol Title, Study Protocol Approval Date, period of data collection)
2. Attach the final report and the copy of the latest approved ICF (as applicable). Also submit turn-it-in results as appropriate.
3. Submit a signed Form 3C, and a version in word form (to be accomplished by the reviewers)
4. Submit the package via email with the following subject: Type of submission_Last name_Code_Panel (Ex: Final Report_Dela Cruz_UPMREB 2020-001-01_Panel 3)

Deviation / Early Termination / Notification / SAE
1. Accomplish the appropriate UPMREB Forms completely and accurately:
a. UPMREB FORM 3(D)2012 Study NonCompliance Report
b. UPMREB FORM 3(E)2012 Early Study Termination Report Form
c. UPMREB FORM 3(G)2012 Suspected Unexpected Serious Adverse Events Report
d. UPMREB FORM 3(I)2012 Queries Notification and Complaints
2. Submit a signed Form, and a version in word form (to be accomplished by the reviewers). Attach applicable documents as necessary.
3. Submit the package via email with the following subject: Type of submission_Last name_Code_Panel (Ex: Deviation / Early Termination / Notification / SAE_Dela Cruz_UPMREB 2020-001-01_Panel 3)