№ files_lp_4_process_3_110284
Provides a detailed framework for preparing and submitting clinical trial documentation, including cover letters, protocols, investigator brochures, IMPD dossiers, informed consent forms, and recruitment procedures, ensuring compliance with CTR Annex I and Belgian regulations.
Year: 2025
Region: European Union / Belgium
Subject: Clinical trial submission and documentation
Document type: Regulatory guidance / annex
Issuing authority: Clinical Trials Coordination Group (CTCG)
Related legislation: EU Clinical Trials Regulation (CTR), ICH E6 GCP
Audience: Sponsors of clinical trials, investigators, ethics committees
Applicable period: From 01/01/2025 for new submissions
Update date: 20/11/2025
References: Eudralex Volume 10, Belgian law of 7 May 2017, EMA guidelines
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.

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