of vomiting or spitting incidents in bioequivalence studies.

3. Responsibilities

• Study Nurse: Observes and reports vomiting or spitting incidents immediately to the physician and documents the event.
• Clinical Research Coordinator (CRC): Ensures all observations are recorded in CRFs and subject logs.
• Study Physician: Assesses the subject’s clinical condition and determines whether re-dosing or withdrawal is necessary.
• PI: Decides on subject continuation in the study and signs off all records related to the event.

4. Accountability

The Principal Investigator is accountable for clinical decisions following any post-dosing vomiting or spitting events and for ensuring the incident is reported and managed per regulatory guidelines.

5. Procedure

5.1 Observation Window

1. All subjects shall be continuously observed for at least 2 hours post-dose or as per protocol requirements.
2. Special attention must be paid during the first hour post-dose, when most vomiting events are likely.

5.2 Identification of Incident

1. If the subject vomits or spits:
   • Record exact time of dosing and time of vomiting/spitting.
   • Estimate time interval (in minutes) between dosing and incident.
2. Inform the study physician immediately for assessment.

5.3 Classification of Event

1. Classify as:
   • Vomiting: Expulsion of gastric contents
   • Spitting: Expulsion of un-swallowed drug or liquid immediately after dosing
2. Record clinical observations in Annexure-1: Vomiting/Spitting Event Form.

5.4 Clinical Evaluation and Action

1. The study physician shall:
   • Assess the condition of the subject
   • Determine whether the event affects absorption or requires study withdrawal
   • Consider re-dosing if protocol allows and safety permits
2. Decision must be documented and countersigned by the PI.

5.5 Documentation and Reporting

1. All events must be documented in:
   • Annexure-1
   • CRF – Adverse Event and Dosing Deviation pages
2. Report the incident in the study deviation log and to the sponsor if necessary.

5.6 Subject Follow-Up

1. Continue monitoring vitals and adverse signs for the next 6–8 hours.
2. Provide supportive medical care as advised by the physician.
3. Document all follow-up actions in Annexure-2: Clinical Follow-Up Log.

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• CRC: Clinical Research Coordinator
• PI: Principal Investigator
• CRF: Case Report Form

7. Documents

1. Vomiting/Spitting Event Form – Annexure-1
2. Clinical Follow-Up Log – Annexure-2

8. References

• ICH E6(R2) – Good Clinical Practice
• Study Protocol and Monitoring Plan
• Indian GCP Guidelines

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Vomiting/Spitting Event Form

Subject ID	Dose Time	Event Time	Type	Symptoms	Decision	Physician
VOL-096	08:00 AM	08:07 AM	Spitting	None	Included with note	Dr. A. Shah

Annexure-2: Clinical Follow-Up Log

Time	BP	Pulse	Temp	Symptoms	Remarks
09:00 AM	118/76	70	36.7°C	Stable	Monitoring continued

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
15/01/2022	1.0	Initial SOP	New Study Procedure	QA Head
17/04/2025	2.0	Included follow-up and Annexure separation	Audit Requirement	QA Head