Post REVIEW Approval

Amendment refers to any modification or revision to a research protocol that is made after its official approval.

Researchers are required to ensure that all changes, whether minor or major, are submitted to and approved by the Research Ethics Review Committee (RERC) prior to implementation. Implementation of amendments without prior approval constitutes a protocol violation.

📝 Step-by-Step Submission Guide 

Step 1: Download & Complete the Amendment Form

1. Click here to download the form: 👉  Protocol Amendment Review Form 3.17.1 

2. Open in Microsoft Word.

3. Complete all required fields—do not leave blanks.

4. Do not modify the original formatting of the form.

Step 2: Prepare the Amended Protocol

1. Clearly highlight all changes in bold text.

2. Include line numbering for reference.

3. Add a footer on every page with(Version number & Version date)

4. Save the final protocol as a PDF.

Step 3: Attach Supporting Documents

1. Include all relevant documents justifying the amendment.

2. Make sure files are complete and properly labeled.

Step 4: Submit Online

1. Visit the RERC submission portal: 👉 https://bit.ly/3LNdGL7 

2. Upload: Completed Form 3.17.1 (Word), Amended Protocol (PDF), Supporting Documents

Step 5: Notify the Committee

1. Send an email to the RERC office confirming your submission.

A Progress Report / Continuing Review Application is a formal communication submitted by the Primary Investigator (PI) or researcher to update the Research Ethics Review Committee (RERC) on the status and progress of the study.

Through this report, the Committee will be informed of:

• Changes in the participant population

• Withdrawals from the study

• Modifications in the recruitment process

• Updates in the informed consent process

• Discovery of new evidence relevant to the study, which should be incorporated in the literature review

Frequency of report submission will really depend on the amount of the risk that a study will harbor.  But generally, all studies MUST SUBMIT THEIR PROGRESS REPORT EVERY THREE (6) MONTHS OR AT INTERVALS APPROPRIATE FOR THE DEGREE OF RISK, DURATION OF THE STUDY PROTOCOL AND SAMPLE SIZE AND TO FILE  CONTINUING REVIEW ANNUALLY AS PER RENEWAL OF THE ETHICAL CLEARANCE.  

📝 Step-by-Step Submission Guide 

Step 1: Download the Form

1. Click the download link: 👉Progress Report / Continuing Review Application Form 3.18.1 

2. Open the form in Microsoft Word

3. Save a copy to your device
   
   

Step 2: Complete the Form

1. Fill all sections of the form; do not leave any questions unanswered

2. Include the electronic signature of the Principal Investigator (PI)

3. Add the date of signature

4. Double-check that all required information is complete

5. Forms missing information or signatures will not be accepted

Step 3: Submit the Form Online

1. Go to the RERC submission portal: 👉https://bit.ly/3LNdGL7 

2. Upload: Completed Form 3.18.1 (Word), Any supporting documents, if applicable

Step 4: Notify the Committee

1. Send an email to the RERC office confirming your submission

The purpose of reporting protocol deviations and violations is to protect the safety and welfare of human participants and to uphold the credibility and integrity of the research data. Researchers are required to report any protocol deviations or violations related to the approved study within one week of the occurrence. 

📝 Step-by-Step Submission Guide 

Step 1: Download the Form

1. Click the download link: 👉  Protocol Deviation / Non-Compliance / Violation Report Form 3.19.1 

2. Open the form in Microsoft Word

3. Save a copy to your device
   
   

Step 2: Complete the Form

1. Fill all sections; do not leave any questions unanswered

2. Ensure that all information is accurate and complete

Step 3: Submit the Form Online

1. Go to the RERC submission portal: 👉 https://bit.ly/3LNdGL7 

2. Upload the completed form
   
   

Step 4: Notify the Committee

1. Send an email to the RERC office confirming your submission

The Batangas Medical Center Research Ethics Review Committee (BATMC-RERC) requires the submission of reports of Serious Adverse Events (SAEs) and Suspected Unexpected Serious

Adverse Reactions (SUSARs) by the Sponsor or Principal Investigator (PI) within the following timelines:

On-Site Cases (Within BATMC or its affiliated research sites)

• Fatal or life-threatening SAEs/SUSARs: Within 24 to 48 hours of awareness, followed by a detailed report within 7 calendar days.

• Non-fatal SAEs/SUSARs: Within 7 calendar days, with a final detailed report within 15 calendar days.

Off-Site Cases (External sites or multi-center trials)

• To be listed in the progress report form and to be reported during review of the progress report.

Review and Oversight Process:

• On-site SAE/SUSAR cases shall undergo Full Board Review to ensure a thorough evaluation of risks, causality, and necessary corrective actions.

• Off-site SAE/SUSAR cases shall be included in the progress report

📝 Step-by-Step Submission Guide 

Step 1: Download the Form

1. Click the download link: 👉  Form 3.20.1-SAE_ SUSAR Summary Report (On Site) 

2. Open the form in Microsoft Word

3. Save a copy to your device
   
   

Step 2: Complete the Form

1. Fill all fields in Form 3.20.1 – SAE/SUSAR Summary Report

2. Ensure that all information is accurate and complete

Step 3: Prepare Supporting Documents

1. CIOMS Serious Adverse Reaction Form

2. Latest Investigator’s Brochure

3. Protocol Summary

4. Any other relevant documents

5. Ensure all files are clearly labeled and complete
   
   

Step 4: Submit Online

1. Go to the RERC submission portal: 👉  https://bit.ly/3LNdGL7 

2. Upload the form and all supporting documents
   
   

Step 5: Notify the Committee

1. Send an email to the RERC office confirming your submission

The review of RNE reports aims to ensure that the safety and welfare of human participants and the research team are safeguarded and that information on RNEs are properly documented and evaluated.

The BATMC-REC shall require the submission of RNE reports, at the latest three (3) days after the event has come to the attention of the researcher.

📝 Step-by-Step Submission Guide 

Step 1: Download the RNE Form

1. Click the RNE form link: 👉 Form 3.21.1-Report of Negative Events  

2. Once the form opens, go to the “File” tab (upper left corner).

3. Select “Download” → “Microsoft Word (.docx)” to save the editable version on your device.
   
   

Step 2: Complete the RNE Form

1. Ensure that all sections are fully completed — do not leave any fields blank.

2. Provide accurate and concise details of the negative event.

3. Include supporting documents if applicable.

4. Note: Incomplete forms or incorrect formats may delay processing.

Step 3: Submit the RNE Form

1. Go to the submission portal: 👉 https://bit.ly/3LNdGL7 

2. Upload the completed Word (.docx) version of your form.
   
   

Step 4: Notify BATMC-REC

1. Send an email to the RERC office confirming your submission

Research may be terminated early or prematurely because of various reasons, such as poor participant recruitment, frequent occurrence of adverse reactions, insufficient funding, etc. In these cases, early protocol termination may be recommended by the Data Safety Monitoring Board (DSMB), the scientific director, the sponsor, the PI, the RERC itself, and/or other authorized bodies. A plan for early termination shall include reason/s for termination and also strive to ensure the safety and privacy of already recruited participants. Applications for early termination shall undergo full board review.

📝 Step-by-Step Submission Guide 

Step 1: Download the Forms

1. Click the download links:👉 Form 3.22.1-Early Study Termination 

2. Open each form in Microsoft Word

3. Save a copy to your device
   
   

Step 2: Complete the Forms

1. Fill all sections; do not leave any questions unanswered

2. Ensure all information is accurate and complete

3. Include Principal Investigator’s signature and date

4. Prepare a Request for Termination Memorandum including: Brief summary of study protocol, Study results, Accrual data
   
   

Step 3: Submit the Forms Online

1. Go to the submission portal: 👉 forms.gle/RVEFwPLahdACBK3f9  

2. Upload all completed Word documents
   
   

Step 4: Notify the Committee

1. Send an email to the RERC office confirming your submission

The BATMC-RERC requires that a Final Report be submitted no later than four (4) weeks after the end of the study.

Definition of “End of Study”:

• For BATMC-initiated protocols: The end of study is marked by the dissemination date of the Final Report by the department.

• For Clinical Trials: The end of study is based on the definition stated in the Clinical Trial Agreement.

• For non-BATMC initiated protocols (excluding clinical trials): The end of study will follow the timeline outlined in the Principal Investigator’s submitted Gantt Chart.
  
  

Important Notes:

• Final reports will undergo Expedited Review, unless there are noted deviations or violations from RERC-approved protocols.

• Submission and review of the final report signify the formal completion of the study and its acceptance by the Research Ethics Committee.

📝 Step-by-Step Submission Guide 

Step 1: Download the Form

1. Click the download link: 👉 Form 3.23.1-Final Report 

2. Open the form in Microsoft Word

3. Save a copy to your device

Step 2: Complete the Form

1. Fill all sections; do not leave any questions unanswered

2. Include the Principal Investigator’s signature and date

3. Prepare and attach the following documents: Final paper, Final statistical analysis, Plagiarism report, Dissemination form and Departmental approval

Step 3: Submit the Form Online

1. Go to the submission portal: 👉 https://bit.ly/3LNdGL7 

2. Upload the completed Word form along with all required attachments

Step 4: Notify the Committee

1. Send an email to the RERC office confirming your submission