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
- 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
- Place the subject in a comfortable position and ensure proper ventilation.
- Provide fluids (if allowed by protocol) for dehydration or dizziness.
- Apply cold compress for headache or rashes.
- 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
- 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
- Inform the Investigator or Sub-Investigator for review and signature.
5.4 Escalation Criteria
- If symptoms worsen or do not resolve with first-aid, initiate medical evaluation.
- Convert to Adverse Event (AE) or Serious Adverse Event (SAE) reporting pathway as needed.
5.5 First-Aid Supplies Checklist
- Maintain a stocked and easily accessible first-aid kit in the clinical area.
- Checklist to include:
- Cotton, antiseptic, gauze, gloves
- Paracetamol, antiemetics, antihistamines
- ORS sachets, thermometer, glucose powder
- 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
- Mild Reaction First-Aid Log – Annexure-1
- 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 |