Initial Submission

For the initial submission of a New Protocol Application for ethics review, please prepare and submit the following documents using the file names written in BOLD letters:

01 Request Letter

- addressed to REC Head Dr. Josephine M. Lumitao and signed by all authors.

02 Endorsement Letter

- certification issued / signed by your Dept. Research Committee stating technical review, approval, and endorsement addressed to REC Head Dr. JM Lumitao. For USTH Trainees, letter must be noted by DMER.

03 F06 Requirements Checklist Form

- properly accomplished REC F06 Form.

04 F07 Application Form

- properly accomplished REC F07 Form.

05 F08 Assessment Form

- properly accomplished signed and dated REC F08 Form.

06 F22 Compliance Form

- must be signed by all authors.

07 Research Protocol v1

- Manuscript with version date & no. (e.g. Protocol Version 1 dated DD_MM_YYYY) & pagination.

08 Informed Consent Forms English/Filipino v1

- must consist of 2 parts. (Information Sheet & Certificate of Consent) - e.g. ICF English/Filipino Version 1 dated DD_MM_YYYY.

09 CV - First Name Surname

- updated short CV,signed & dated of all authors,co-authors and research adviser.

10 GCP - First Name Surname

- must be issued by a local GCP provider (3 years validity period)

11 Review Fee - Charge Slip/Official Receipt.

- scanned copy of charge slip and official receipt

12 Others

- Tracking Form, Data Collection Forms, Questionnaires, Recruitment Materials, Permission Letters, etc.

Instructions & Reminders:

For initial submission of new protocol for ethics review, please prepare / submit the following documents using the "file names" indicated in this guideline (e.g. 01 Request Letter).

FOR ONLINE SUBMISSION: Submit the complete requirements in pdf format except REC F08 & F27 (must be in docx/word. format).

FOR PRINTED COPY SUBMISSION : Provide 1 printed copy (complete set).

Formatting Requirements:

Paper: A4 size
Font: Arial, size 11
Folder: 1.5 inch,2-hole black arch file
Number of Copies: 1 complete set

*Incomplete submission will not be accepted/processed.

For further inquiries, please do not hesitate to call +63 2 8731-3001 local 2610 or email us at usthrec@gmail.com

The REC Forms may be downloaded here:

FORMS

Instruction for Resubmission

1. Integrate the modifications into a revised research protocol, consent forms, and related

documents, as applicable.

2. Submit revised protocols and consent forms on A4-sized paper, using Arial font at 12-

point size. Please ensure double-spacing throughout, except for the title page.

3. Begin each main document on a new page. Update the footer to include both the

creation date and version number. Any modified sections should be highlighted in bold.

4. Submit a properly accomplished, signed and dated REC Resubmission Form (F11)

along with your revised research protocol and/or consent forms, as applicable.

5. Include a submission letter addressed to the Head of the REC.

6. Attach the REC-issued letter containing recommendations, comments, and questions

for the reviewer's reference.

7. Submit an electronic copy of the revised documents via the USTH-REC website:

usthrec.online.

8. Provide one printed copy, placed in an ordinary folder, to the REC Office.

9. Adhere to the updated submission schedule effective November 2021, as follows:

Online submissions: Every Monday-Friday, no later than 12:00

midnight.

Printed copy submissions: Every Wednesday and Friday, between 9:00 AM and 3:00 PM.

Resubmission

For the submission of a Resubmitted/Revised Protocol for review and approval, please prepare and submit your documents using the file names written in BOLD letters:

1. Request Letter

- addressed to REC Head Dr. Josephine M. Lumitao and signed by all authors.

2. F11 Resubmission Form

- Properly completed REC Form (see attached F11) signed by all authors.

3. Amended Protocol / Informed Consent Forms

- Include the version number and date (Version No. _ dated day_month_year).

4. Other Documents Needing Revision

- Includes ICFs, Data Collection Forms, GANTT Chart, etc.

Reminders:

For Resubmission of Revised Protocols:

No need to resubmit CV and GCP.
Integrate revisions into the revised/amended research protocol, consent forms, and related documents.

For further inquiries, please do not hesitate to call +63 2 8731-3001 local 2610 or email us at usthrec@gmail.com

The REC Forms may be downloaded here:

FORMS

Protocol Amendment

For the submission of a Protocol Amendment for review and approval, please prepare and submit your documents using the file names written in BOLD letters:

1. Request Letter

- addressed to REC Head Dr. Josephine M. Lumitao and signed by all authors.

2. F14 Amendment Form

- Properly accomplished, signed and dated REC F14 Form signed by all authors.

3. Amended Protocol / Informed Consent Forms

- Include the version number and date (Amended Protocol Version No. _ dated day_month_year).

4. Other Documents As Needed

- ICFs, Data Collection Forms, GANTT Chart, Updated CV and/or GCP etc.

Reminders:

For Submission of Protocol Amendments:

No need to resubmit CV and GCP, Unless needed to update.
Integrate revisions into the amended research protocol, consent forms, and related documents.

FOR ONLINE SUBMISSION: Submit the above requirements in pdf format except REC F14 (must be in docx/word. format).

FOR PRINTED COPY : Please Provide 1 printed copy (complete set).

For further inquiries, please do not hesitate to call +63 2 8731-3001 local 2610 or email us at usthrec@gmail.com

The REC Forms may be downloaded here:

FORMS

Final Report

For the submission of a Final Report for review and approval, please prepare and submit your documents using the file names written in BOLD letters:

1. Request Letter

- addressed to REC Head Dr. Josephine M. Lumitao and signed by all authors.

2. F18 Final Report Form

- Properly accomplished, signed and dated REC F18 Form signed by all authors.

3. Final Report Protocol / Manuscript

- Include the version number and date (Final Report Protocol Version No. 1 dated day_month_year).

4. Other documents as needed

- Permission Letters secured from Medical Director, Data Privacy Officer and other department/units concerned.

Reminders:

For Submission of Final Report:

No need to resubmit CV and GCP.

Submit the above requirements in pdf format except REC F18 (must be in docx/word. format).

For further inquiries, please do not hesitate to call +63 2 8731-3001 local 2610 or email us at usthrec@gmail.com

The REC Forms may be downloaded here:

FORMS

Exemption From Review

For application for Exemption from review please submit the following:

1. Letter of intent/request addressed to REC Head signed by the all authors

DR. JOSEPHINE M. LUMITAO

Head

Research Ethics Committee

University of Santo Tomas Hospital

2. Properly accomplished REC Forms

a. F07 Application Form

b. F24 Exemption Review Form (to be submitted in word format)

3. Meta analysis protocol with version no. & date

4. updated short CV - signed & dated

5. updated local GRP/GCP certificate

6. Proof of review fee payment (scanned copy of official receipt)

Reminders:

Submit the above requirements in pdf format except REC F24 & F27 (must be in docx/word. format).

For further inquiries, please do not hesitate to call +63 2 8731-3001 local 2610 or email us at usthrec@gmail.com

The REC Forms may be downloaded here:

FORM