Trusted Resource for Clinical Trials, Protocols & Progress
The purpose of this SOP is to define procedures for labeling investigational devices and applying Unique Device Identification (UDI) requirements in clinical trials. Proper labeling ensures device traceability, subject safety, regulatory compliance, and consistency across global studies.
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The purpose of this SOP is to establish standardized oversight procedures for clinical trials involving drug-device combination products. It ensures that both drug and device components are managed, documented, and monitored in compliance with global regulatory requirements, maintaining subject safety and data integrity.
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The purpose of this SOP is to establish standardized procedures for handling and reporting samples in in vitro diagnostic (IVD) clinical trials. Proper sample handling and accurate reporting ensure subject safety, data integrity, regulatory compliance, and validity of trial outcomes.
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The purpose of this SOP is to establish standardized procedures for the design and regulatory submissions of clinical trials involving Advanced Therapy Medicinal Products (ATMPs), including gene therapies, cell therapies, and tissue-engineered products. This ensures patient safety, data integrity, and regulatory compliance across regions.
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The purpose of this SOP is to define the processes required to maintain Chain of Identity (CoI) and Chain of Custody (CoC) for cell and gene therapy products used in clinical trials. These processes ensure traceability, product integrity, subject safety, and regulatory compliance from collection through administration and follow-up.
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The purpose of this SOP is to establish GMP-compliant procedures for handling gene and cell therapy products at clinical trial sites. Proper handling ensures product quality, subject safety, data integrity, and compliance with global regulatory requirements.
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The purpose of this SOP is to define standardized procedures for the long-term follow-up (LTFU) of subjects enrolled in Advanced Therapy Medicinal Product (ATMP) clinical trials. Due to the potential for delayed adverse events, gene integration risks, and long-term immunogenicity, subjects must be followed beyond the trial’s active treatment phase to ensure safety and regulatory compliance.
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The purpose of this SOP is to define standardized procedures for traceability of cell and tissue-based products used in clinical trials of Advanced Therapy Medicinal Products (ATMPs). Traceability ensures donor-to-patient linkage, product integrity, subject safety, and regulatory compliance throughout collection, processing, distribution, administration, and long-term follow-up.
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The purpose of this SOP is to establish standardized procedures for cold-chain management of vaccines in clinical trials, with a focus on large-scale and mass vaccination trials. Proper cold-chain practices ensure product stability, subject safety, and compliance with international regulatory requirements.
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The purpose of this SOP is to define standardized procedures for accountability and reconciliation of investigational vaccines (IP) used in clinical trials, as well as to describe actions for handling wastage and spillage. These procedures safeguard trial integrity, ensure accurate dosing records, and maintain regulatory compliance.
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