INITIAL SUBMISSION

📋 Initial Requirements for Ethics Review

1️⃣ Submission of Letter of Intent

For external research submissions: Please submit a Letter of Intent, addressed as follows:

MARITESS TERESITA M. TORIO, MD, FPPS, FPSPME
Medical Center Chief II, Batangas Medical Center

Through:
TERESITA RISALYN V. VILLANUEVA, MD, FPPS
Chief, Professional Education Training and Research Office

(Submit via email to: batmcrc@gmail.com)

2️⃣ Memorandum of Agreement (MOA)

(Required if a single institution expects to submit multiple or regular requests for ethics review)

• Submit a draft MOA.

• Upon receipt and review of the Letter of Intent and MOA:
  a. The MOA will be forwarded to our Legal Division for review and revision (with inputs from the institution’s Legal representative and the sponsor/CRO counterpart).
  b. Finalized MOA will be signed by all parties.

3️⃣ Certificate of Research Technical Review

• Valid for 6 months.

• Required for all ethics review submissions.

4️⃣ Complete Protocol Package

• Refer to 👉 Complete Protocol Package form.

• All forms must be completely filled out, with the name and signature of the Principal Investigator (PI). 

• Submit completed form in Word format — do not alter the original formatting.

5️⃣ Curriculum Vitae (CV) & Good Clinical Practice (GCP) Certificate of (Primary Investigator, Co-Investigator and Study Team if there is any)

• GCP Certificate must be current within the last 2 years.

• Include any other relevant documents.

6️⃣ Research Protocol Formatting

• Use Continuous Line Numbering (see "PAGE LAYOUT" in MS Word).

• Convert to PDF (A4 size) after adding line numbering.

• Add a footer to every page with:

  • Submission Date

  • Version Number

7️⃣ Informed Consent Form (ICF)

• Use the 👉 WHO ICF TEMPLATE.

8️⃣ Plagiarism Checker Result & Statistician Clearance Certificate

• Plagiarism similarity: 20% or less, updated within the last 6 months.

• Exclude dummy tables and bibliography from the plagiarism check.

• Include an updated Statistician Clearance Certificate.

9️⃣ Non-Disclosure Forms of (Primary Investigator, Co-Investigator and Study Team if there is any)

• Complete the following forms:
  👉 Non-Disclosure Agreement Form for BatMC Personnel (Form 2.7.5)
  👉 Non-Disclosure Undertaking-Site Outside BatMC (Form 2.7.6)

• The Non-Disclosure Agreement (NDA) must be notarized. 

🔟 Other Supporting Documents

• Submit any other applicable documents.