facility.

3. Responsibilities

• Phlebotomist/Nurse: Accurately collects samples at specified time points and reports any delay.
• Clinical Research Coordinator: Logs the actual sampling time and assesses deviation magnitude.
• Principal Investigator: Reviews and signs off on deviation documentation.
• QA Personnel: Audits sampling logs for compliance and trending.

4. Accountability

The Clinical Operations Manager is accountable for ensuring that all deviations in PK sampling time are identified, recorded, assessed, and communicated appropriately to maintain study data integrity.

5. Procedure

5.1 Definition of PK Sampling Deviation

1. Deviation is defined as any sampling time that falls outside the permitted ± window as specified in the protocol (commonly ±2 min to ±5 min depending on the time point).
2. Minor deviations (within protocol-specified range) are to be recorded but do not require CAPA.
3. Major deviations (outside window or missed samples) must be documented and evaluated for impact.

5.2 Documentation of Actual Sampling Time

1. Record actual time of blood collection in 24-hour format on:
   • PK Sampling Log
   • CRF
   • Source Document
2. Use Annexure-1: PK Sampling Deviation Log to document any deviations.

5.3 Categorization and Evaluation

1. Deviations shall be categorized as:
   • Early Sample: Collected before scheduled time
   • Late Sample: Collected after scheduled time
   • Missed Sample: Not collected at all
2. Evaluate the impact based on:
   • Time point (e.g., Cmax, Tmax critical points)
   • Deviation duration
   • Frequency of occurrence
3. Involve Bioanalytical Principal Scientist in decision-making if required.

5.4 CAPA and Communication

1. Prepare a CAPA using Annexure-2: PK Sampling Deviation CAPA Form for major deviations.
2. Communicate the deviation in the site deviation report and include in study summary.
3. Notify the sponsor or regulatory body if deviation is frequent or critical (as per agreement).

5.5 Trend Analysis and Preventive Actions

1. QA shall review sampling deviations monthly.
2. Implement retraining, checklist improvements, or automated alarms to reduce reoccurrence.
3. Document preventive actions in Annexure-3: Deviation Trending Log.

6. Abbreviations

• PK: Pharmacokinetic
• BA: Bioavailability
• BE: Bioequivalence
• CRF: Case Report Form
• CAPA: Corrective and Preventive Action
• QA: Quality Assurance

7. Documents

1. PK Sampling Deviation Log – Annexure-1
2. PK Sampling Deviation CAPA Form – Annexure-2
3. Deviation Trending Log – Annexure-3

8. References

• ICH E6(R2) – Good Clinical Practice
• US FDA Bioanalytical Method Validation Guidance
• Protocol-specific time window definitions

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: PK Sampling Deviation Log

Subject ID	Scheduled Time	Actual Time	Deviation (min)	Type	Remarks
V021	10:00	10:07	+7	Late	Volunteer delay

Annexure-2: PK Sampling Deviation CAPA Form

Deviation Description	Root Cause	Corrective Action	Preventive Action	Closed By
Missed 4-hr sample	Shift handover error	Reminder checklist added	Shift logbook updated	QA Manager

Annexure-3: Deviation Trending Log

Month	Total PK Samples	Deviations	% Deviation	Comments
March 2025	960	14	1.46%	Within limit

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
10/01/2022	1.0	Initial SOP Release	Regulatory Requirement	QA Head
17/04/2025	2.0	Added trending and early/late deviation classification	Audit Observation	QA Head