SAE & SUSAR (Onsite)

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

SAE/SUSAR Submission Requirements:

To ensure proper processing, please complete all fields in the Form 3.20.1-SAE_ SUSAR Summary Report (On Site) and submit it along with the following supporting documents:

• CIOMS Serious Adverse Reaction Form (Appendices – Reference No. 8)

• Latest version of the Investigator’s Brochure

• Protocol Summary

• Any other relevant supporting documents, if applicable
  
  

*Please note: Kindly ensure all documents are submitted together for timely review and assessment.

How to download:

• Click the link and open the form

• Go to "File" tab found in the upper left corner of the screen

• Go to "Download" and select "Microsoft Word (.docx)"

📂 How to Submit

✅ Complete all required forms — no blank fields.
✅ Upload via: 👉 https://bit.ly/3LNdGL7
✅ After submission, notify us via email.