SOP for Paediatric Investigation Plan (PIP) Obligations Tracking

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Published on 24/12/2025

Standard Operating Procedure for Paediatric Investigation Plan (PIP) Obligations Tracking

SOP No.	CR/OPS/140/2025
Supersedes	NA
Page No.	X of Y
Issue Date	26/08/2025
Effective Date	01/09/2025
Review Date	01/09/2026

Table of Contents

Purpose

The purpose of this SOP is to establish a standardized process for managing Paediatric Investigation Plan (PIP) obligations as mandated under the European Paediatric

Regulation (EC No 1901/2006). This ensures that sponsors comply with EMA requirements for the development and authorization of medicines intended for use in children, including deferrals and waivers.

Scope

This SOP applies to sponsors, CROs, regulatory affairs, clinical development, and QA personnel responsible for paediatric clinical development in the EU. It covers PIP submission, tracking obligations, reporting modifications, monitoring deferrals/waivers, and ensuring readiness for EMA inspections.

Responsibilities

Sponsor: Prepares, submits, and tracks PIP obligations with EMA and ensures timely reporting.
Regulatory Affairs: Manages PIP correspondence, submissions, and modifications in CTIS.
CRO: Supports operationalization of PIP trials and assists with reporting.
Clinical Development: Aligns trial design with approved PIP requirements.
QA: Audits PIP compliance and ensures inspection readiness.

Accountability

The Sponsor’s Regulatory Affairs Lead is accountable for PIP compliance and timely fulfilment of obligations.

Procedure

1. PIP Preparation and Submission
1.1 Draft PIP in accordance with EMA requirements.
1.2 Submit via EMA’s Paediatric Committee (PDCO) portal.
1.3 Record submission in PIP Submission Log (Annexure-1).

2. Deferrals and Waivers
2.1 Identify if waiver or deferral applies.
2.2 Obtain formal approval from EMA.
2.3 Record in Waiver/Deferral Log (Annexure-2).

3. Modifications
3.1 Submit modifications for significant changes in study design or timelines.
3.2 Track approvals in PIP Modification Log (Annexure-3).

4. Tracking Obligations
4.1 Monitor timelines for PIP-related milestones.
4.2 Use internal tracking tools for trial execution.
4.3 Record updates in PIP Tracking Log (Annexure-4).

5. Results Reporting
5.1 Submit paediatric study results within required timelines.
5.2 Document in PIP Results Log (Annexure-5).

6. Inspection Readiness
6.1 Maintain inspection-ready records for PIP compliance.
6.2 Archive documentation in TMF.
6.3 Record in PIP Archiving Log (Annexure-6).

Abbreviations

SOP: Standard Operating Procedure
PIP: Paediatric Investigation Plan
EMA: European Medicines Agency
PDCO: Paediatric Committee
CRO: Contract Research Organization
QA: Quality Assurance
TMF: Trial Master File
CTIS: Clinical Trials Information System

Documents

PIP Submission Log (Annexure-1)
Waiver/Deferral Log (Annexure-2)
PIP Modification Log (Annexure-3)
PIP Tracking Log (Annexure-4)
PIP Results Log (Annexure-5)
PIP Archiving Log (Annexure-6)

References

Version: 1.0

Approval Section

Prepared By	Ravi Kumar, Regulatory Affairs Specialist
Checked By	Sunita Reddy, QA Officer
Approved By	Dr. Anil Sharma, Head Clinical Operations

Annexures

Annexure-1: PIP Submission Log

Date	Protocol ID	Submission Status	Submitted By	Status
01/09/2025	PIP-2025-01	Submitted	Reg Affairs	Filed

Annexure-2: Waiver/Deferral Log

Date	Protocol ID	Waiver/Deferral	Approved By	Status
03/09/2025	PIP-2025-01	Deferral	EMA	Approved

Annexure-3: PIP Modification Log

Date	Protocol ID	Modification	Submitted By	Status
05/09/2025	PIP-2025-01	Protocol Amendment	Reg Affairs	Approved

Annexure-4: PIP Tracking Log

Date	Milestone	Responsible	Status
10/09/2025	Submission of Results	Data Manager	Ongoing

Annexure-5: PIP Results Log

Date	Protocol ID	Results Submitted	Submitted By	Status
15/09/2025	PIP-2025-01	Yes	Reg Affairs	Filed

Annexure-6: PIP Archiving Log

Date	Protocol ID	Archived By	Location	Status
20/09/2025	PIP-2025-01	QA Officer	TMF	Archived

Revision History

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
26/08/2025	00	Initial version	New SOP creation	Head Clinical Operations

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