Standard Operating Procedure for Trial Registration with EudraCT in BA/BE Studies

Department	BA-BE Studies
SOP No.	SOP/BA-BE/044/2025
Supersedes	SOP/BA-BE/044/2022
Page No.	Page 1 of 11
Issue Date	17/04/2025
Effective Date	20/04/2025
Review Date	17/04/2026

1. Purpose

To define the process for registering BA/BE clinical trials in the European Clinical Trials Database (EudraCT) in accordance with European Medicines Agency (EMA) requirements for transparency, regulatory compliance, and study oversight.

2. Scope

This SOP is applicable to all BA/BE studies that are required to be registered in the EudraCT system, either as part of regulatory submissions to EU member states or for clinical trial applications involving investigational medicinal products in Europe.

3. Responsibilities

• Regulatory Affairs: Responsible for initiating, completing, and submitting the EudraCT registration dossier.
• Clinical Project Manager: Provides protocol, site, and sponsor-related details required for registration.
• Quality Assurance: Verifies EudraCT documentation during audits and inspections.

4. Accountability

The Head of Regulatory Affairs is accountable for ensuring that no study involving EU submission proceeds without a valid EudraCT number and confirmation of registration completion.

5. Procedure

5.1 Pre-Registration Requirements

1. Ensure the final protocol and Investigator’s Brochure (IB) are approved and available in English.
2. Ensure the sponsor holds a valid EudraCT user account.
3. Obtain Ethics Committee (EC) contact and site details for inclusion in the form.

5.2 EudraCT Registration Steps

1. Log in to the European Commission EudraCT portal at https://eudract.ema.europa.eu/.
2. Select “Create Clinical Trial Application” and generate a new EudraCT number.
3. Fill in the required sections, including:
   • Trial identification
   • Sponsor and CRO details
   • Product and trial characteristics
   • Subject inclusion criteria
   • Safety and IMPD data
4. Upload supporting documents (protocol, IB, informed consent form).
5. Electronically sign and submit the application.

5.3 Confirmation and Documentation

1. Upon successful submission, download and archive the EudraCT summary report.
2. Record the generated EudraCT number in Annexure-1: Trial Registration Log.
3. Notify internal stakeholders and CRO partners regarding registration completion.

5.4 Amendments and Updates

1. For any protocol amendment or change in site/sponsor, update the trial entry in the EudraCT system within 15 days.
2. Maintain update records in Annexure-2: Registration Amendment Tracker.

5.5 Public Disclosure

1. Ensure clinical trial results are posted in the EU Clinical Trials Register within 12 months of study completion.
2. Responsibility lies with the sponsor to comply with posting timelines.

6. Abbreviations

• BA: Bioavailability
• BE: Bioequivalence
• EMA: European Medicines Agency
• IB: Investigator’s Brochure
• EC: Ethics Committee
• CRO: Contract Research Organization

7. Documents

1. Trial Registration Log – Annexure-1
2. Registration Amendment Tracker – Annexure-2

8. References

• EMA EudraCT User Manual
• Regulation (EU) No 536/2014 on Clinical Trials
• ICH E6(R2) – Good Clinical Practice

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Trial Registration Log

Study Title	Protocol No.	EudraCT No.	Registration Date	Registered By
BE Study for XYZ Tablets	BE-045	2025-000123-45	15/04/2025	Sunita Reddy

Annexure-2: Registration Amendment Tracker

EudraCT No.	Amendment Type	Date Submitted	Submitted By	Status
2025-000123-45	Site Addition	28/04/2025	Rajesh Kumar	Approved

Revision History:

Revision Date	Revision No.	Details	Reason	Approved By
10/01/2022	1.0	Initial version	New study registration requirement	QA Head
17/04/2025	2.0	Updated per EU Regulation 536/2014 and portal changes	Process harmonization	QA Head