Trusted Resource for Clinical Trials, Protocols & Progress
The purpose of this SOP is to outline procedures for submission and lifecycle management of clinical trials under the European Union Clinical Trials Regulation (EU CTR 536/2014) via the Clinical Trials Information System (CTIS). This ensures regulatory compliance, transparency, and harmonized trial management across EU member states.
Click to read the full article.
The purpose of this SOP is to establish standardized procedures for reporting and managing Suspected Unexpected Serious Adverse Reactions (SUSARs) and Individual Case Safety Reports (ICSRs) through the European Medicines Agency’s (EMA) EudraVigilance system. This ensures compliance with EU Clinical Trials Regulation (CTR), Good Pharmacovigilance Practices (GVP), and applicable EMA guidance.
Click to read the full article.
The purpose of this SOP is to define standardized procedures for handling General Data Protection Regulation (GDPR) data subject rights in clinical trials, specifically access, deletion, and restriction requests. It ensures compliance with EU CTR 536/2014, GDPR Articles 12–23, and EMA guidance while safeguarding subject confidentiality and data integrity.
Click to read the full article.
The purpose of this SOP is to define standardized procedures for labelling Investigational Medicinal Products (IMPs) and medical devices in compliance with European Union requirements under Annex 13 of Directive 2001/20/EC and Annex VI of the EU Medical Device Regulation (EU MDR 2017/745). This ensures subject safety, trial integrity, and regulatory compliance.
Click to read the full article.
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.
Click to read the full article.
The purpose of this SOP is to define requirements and processes for archiving essential clinical trial records for a minimum of 25 years, in compliance with the EU Clinical Trials Regulation (EU CTR 536/2014) and EMA guidance. This SOP ensures sponsor accountability for secure, long-term storage of both paper and electronic records.
Click to read the full article.
The purpose of this SOP is to outline the Qualified Person (QP) certification process and define expectations for the interface between Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) during clinical trial product release. This ensures Investigational Medicinal Product (IMP) batches are certified, documented, and released in compliance with EU GMP Annex 13, EMA guidelines, and EU CTR 536/2014 requirements.
Click to read the full article.
