Standard Operating Procedure for First-Aid Management of Mild Reactions in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/067/2025
Supersedes	SOP/BA-BE/067/2022
Page No.	Page 1 of 9
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To establish a clear and systematic approach for recognizing, providing first-aid, and documenting mild adverse reactions in volunteers participating in Bioavailability/Bioequivalence (BA/BE) studies.

2. Scope

This SOP is applicable to all clinical staff responsible for safety monitoring, emergency readiness, and initial medical intervention for mild events such as nausea, headache, giddiness, or injection-site irritation in BA/BE clinical studies.

3. Responsibilities

• Nursing Staff: Identify symptoms, provide immediate care, and escalate when necessary.
• Clinical Research Coordinator (CRC): Ensure availability of first-aid supplies and document events in the safety log.
• Investigator/Sub-Investigator: Review and approve the first-aid provided and determine follow-up care.

4. Accountability

The Principal Investigator is accountable for ensuring that all mild adverse events are promptly addressed, properly documented, and that staff are trained in basic first-aid procedures.

5. Procedure

5.1 Identification of Mild Reactions

1. Train staff to identify symptoms typically classified as mild reactions:
   • Nausea or vomiting (non-severe)
   • Headache, dizziness
   • Mild rash or itching
   • Transient hypotension not requiring medical intervention

5.2 Immediate First-Aid Management

1. Place the subject in a comfortable position and ensure proper ventilation.
2. Provide fluids (if allowed by protocol) for dehydration or dizziness.
3. Apply cold compress for headache or rashes.
4. Use first-aid kit items such as:
   • Antiemetic tablets for nausea
   • Antihistamines for minor allergic reactions (under PI supervision)
   • ORS solution for mild dehydration

5.3 Documentation of Event

1. Record the incident in Annexure-1: Mild Reaction First-Aid Log, including:
   • Subject ID
   • Time of symptom onset
   • Description and severity
   • First-aid provided
   • Outcome and recovery time
2. Inform the Investigator or Sub-Investigator for review and signature.

5.4 Escalation Criteria

1. If symptoms worsen or do not resolve with first-aid, initiate medical evaluation.
2. Convert to Adverse Event (AE) or Serious Adverse Event (SAE) reporting pathway as needed.

5.5 First-Aid Supplies Checklist

1. Maintain a stocked and easily accessible first-aid kit in the clinical area.
2. Checklist to include:
   • Cotton, antiseptic, gauze, gloves
   • Paracetamol, antiemetics, antihistamines
   • ORS sachets, thermometer, glucose powder
3. Document monthly inspections of first-aid kit in Annexure-2: First-Aid Kit Maintenance Log.

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• PI: Principal Investigator
• AE: Adverse Event
• SAE: Serious Adverse Event

7. Documents

1. Mild Reaction First-Aid Log – Annexure-1
2. First-Aid Kit Maintenance Log – Annexure-2

8. References

• ICH E6(R2) – Good Clinical Practice
• CDSCO Guidelines for Clinical Safety
• WHO First-Aid Training Manual

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Mild Reaction First-Aid Log

Subject ID	Symptom	Onset Time	First-Aid Given	Outcome	Reviewed By
VOL-067	Headache	08:30	Cold compress	Resolved	Dr. Sunita Reddy

Annexure-2: First-Aid Kit Maintenance Log

Date	Inspected By	Items Replenished	Remarks
10/04/2025	Ravi Nair	ORS, gloves	Stocked and verified

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
12/01/2022	1.0	Initial version	BA/BE implementation	QA Head
17/04/2025	2.0	Included escalation pathway and annexure logs	Audit requirement	QA Head