Trusted Resource for Clinical Trials, Protocols & Progress
The purpose of this SOP is to define standardized procedures for the accountability, calibration, and maintenance of devices used in clinical trials. Proper management of devices ensures reliability of data, subject safety, regulatory compliance, and inspection readiness.
Click to read the full article.
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.
Click to read the full article.
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.
Click to read the full article.
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.
Click to read the full article.
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.
Click to read the full article.
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.
Click to read the full article.
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.
Click to read the full article.
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.
Click to read the full article.
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.
Click to read the full article.
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.
Click to read the full article.
