Trusted Resource for Clinical Trials, Protocols & Progress
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.
Click to read the full article.
The purpose of this SOP is to establish standardized workflows for the collection, processing, shipment, storage, and analysis of immunogenicity samples in clinical trials. It also outlines requirements for specialty laboratories performing immunogenicity assays, ensuring accuracy, traceability, and regulatory compliance.
Click to read the full article.
The purpose of this SOP is to define standardized procedures for logistics planning and execution in multi-site mass-vaccination trials. It ensures that investigational vaccines are distributed, stored, and administered under validated conditions, maintaining compliance with global regulatory guidelines and safeguarding subject safety.
Click to read the full article.
The purpose of this SOP is to define pediatric safeguards in clinical trials to ensure ethical conduct, subject safety, and regulatory compliance. It provides procedures for obtaining parental consent and age-appropriate assent, implementing child-centered trial procedures, and ensuring oversight for pediatric research.
Click to read the full article.
The purpose of this SOP is to establish standardized procedures for regulatory interactions in orphan drug clinical trials. Orphan drug trials involve unique challenges due to small patient populations, complex designs, and high unmet medical needs, making effective regulatory communication critical for trial success and compliance.
Click to read the full article.
The purpose of this SOP is to define standardized procedures for implementing remote and electronic informed consent (eConsent) in clinical trials. It ensures compliance with FDA 21 CFR Part 11, EMA eConsent guidelines, GDPR, HIPAA, and ICH GCP, while safeguarding subject autonomy, comprehension, and data privacy.
Click to read the full article.
The purpose of this SOP is to establish standardized procedures for remote and central source data verification (SDV) in decentralized clinical trials. Remote/central SDV ensures data quality, regulatory compliance, and subject safety while reducing the need for onsite monitoring.
Click to read the full article.
The purpose of this SOP is to define procedures for acquiring, managing, and validating data collected from wearable devices and digital biomarkers in clinical trials. It ensures subject safety, data reliability, and compliance with international regulations for decentralized and hybrid trial designs.
Click to read the full article.
The purpose of this SOP is to define standardized procedures for implementing telemedicine visits and remote adverse event (AE) reporting in clinical trials. It enables subject safety, data integrity, and regulatory compliance while facilitating decentralized and hybrid trial designs.
Click to read the full article.
The purpose of this SOP is to define cybersecurity and privacy measures for decentralized clinical trials. It establishes controls for securing clinical trial data, ensuring confidentiality of subject information, preventing unauthorized access, and meeting international regulatory requirements.
Click to read the full article.
