clinical site.

3. Responsibilities

• Study Physician: Assesses the safety impact of concomitant medication and provides approval for inclusion/exclusion.
• Clinical Research Coordinator (CRC): Interviews subjects and documents all medication use prior to and during the study.
• Data Entry Staff: Transfers recorded information into CRFs/eCRFs and flags any inconsistencies.
• Principal Investigator (PI): Reviews all concomitant medication data and signs off.

4. Accountability

The PI is accountable for ensuring that all concomitant medications are properly documented, assessed for impact on study outcomes, and reported to the sponsor and ethics committee as required.

5. Procedure

5.1 Identification of Concomitant Medication

1. At screening and check-in, volunteers shall be asked whether they have taken any prescribed or OTC medication, herbal product, vitamin supplement, or traditional remedy in the past 30 days.
2. Any medication taken within the washout or dosing phase shall be treated as potential concomitant medication.

5.2 Interview and Documentation

1. CRC shall record the following for each medication in Annexure-1:
   • Generic/brand name
   • Dose and dosage form
   • Route of administration
   • Indication
   • Start and stop date
2. If the volunteer is unable to recall the name, ask for prescription/medicine strip or use standard drug references.

5.3 Assessment and Decision

1. Study physician evaluates if:
   • The medication could interfere with the pharmacokinetics of the study drug
   • It affects the safety or efficacy profile of the IMP
2. PI or physician records decision:
   • Subject included with documentation
   • Subject excluded

5.4 Recording in Source Documents and CRFs

1. Document information in Annexure-1 and transcribe into CRF (Annexure-2 for paper studies or via eCRF system).
2. Ensure corrections follow GCP-compliant procedures.

5.5 Updates and Follow-Up

1. Repeat inquiry about new medication use during clinical visits and before discharge.
2. Document any newly identified concomitant medication on follow-up CRF page (Annexure-3).

6. Abbreviations

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

7. Documents

1. Concomitant Medication Interview Form – Annexure-1
2. CRF Concomitant Medication Log – Annexure-2
3. Follow-up Medication Log – Annexure-3

8. References

• ICH E6(R2) – Good Clinical Practice
• Schedule Y – Drugs and Cosmetics Rules
• Study Protocol

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Concomitant Medication Interview Form

Subject ID	Drug Name	Dose	Route	Indication	Start/Stop Date
VOL-095	Paracetamol	500 mg	Oral	Fever	10/04/2025 – 12/04/2025

Annexure-2: CRF Concomitant Medication Log

Subject ID	Drug	Dose	Start Date	End Date	PI Comment
VOL-095	Paracetamol	500 mg	10/04/2025	12/04/2025	No interaction

Annexure-3: Follow-up Medication Log

Subject ID	Drug	Dose	Date of Report	Action Taken
VOL-095	Vitamin C	500 mg	15/04/2025	Continue study

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
12/01/2022	1.0	Initial Issue	New SOP	QA Head
17/04/2025	2.0	Included Follow-up Log and PI Comments	Audit Recommendation	QA Head