Trusted Resource for Clinical Trials, Protocols & Progress
The purpose of this SOP is to define the process for monitoring, managing, and balancing investigator workload to ensure the quality, integrity, and ethical conduct of clinical trials. Proper workload management safeguards participant safety, prevents errors, and ensures compliance with international regulatory standards.
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The purpose of this SOP is to establish standardized procedures for training clinical trial staff in Good Clinical Practice (GCP) and protocol-specific requirements. Training ensures that staff understand regulatory expectations, trial procedures, participant rights, and responsibilities, thereby maintaining compliance and data integrity.
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The purpose of this SOP is to define procedures for assessing training effectiveness and tracking the competency of clinical research staff to ensure compliance with GCP, protocol requirements, and applicable regulatory guidelines. Continuous competency evaluation ensures high-quality data and participant safety in clinical trials.
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The purpose of this SOP is to establish standardized procedures for the development, review, and approval of recruitment materials used in clinical trials. It ensures that all recruitment communications are ethically sound, scientifically accurate, and approved by Ethics Committees (EC) or Institutional Review Boards (IRB) before use.
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The purpose of this SOP is to define the procedures for conducting screening and pre-screening of participants in clinical trials. It establishes standardized practices for maintaining screening logs, assessing eligibility, documenting outcomes, and ensuring compliance with regulatory guidelines.
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The purpose of this SOP is to establish standardized procedures for verifying the eligibility of potential participants in clinical trials by applying inclusion and exclusion criteria defined in the protocol. This ensures participant safety, data reliability, and compliance with ethical and regulatory standards.
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This SOP defines the process for submitting documents, obtaining approvals, and reporting to Research Ethics Boards (REBs) to ensure compliance with Division 5 and ICH-GCP requirements. It establishes timelines, documentation standards, and communication pathways to safeguard participant rights and maintain regulatory oversight throughout the clinical trial lifecycle.
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The purpose of this SOP is to establish a standardized process for assigning unique subject identification (ID) numbers and maintaining tracking logs in clinical trials. This ensures participant confidentiality, data integrity, and traceability throughout the study.
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The purpose of this SOP is to establish clear, regulatory-compliant processes for the identification, assessment, documentation, and reporting of Serious Adverse Events (SAEs), Suspected Unexpected Serious Adverse Reactions (SUSARs), and Development Safety Update Reports (DSURs) to Health Canada. It ensures timely communication, protects subject safety, maintains sponsor obligations under Division 5 of the Food and Drug Regulations, and aligns with ICH-GCP and ICH E2A/E2F guidelines.
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The purpose of this SOP is to define the procedures for handling participant withdrawals and dropouts during clinical trials. This ensures that participant rights are respected, safety is prioritized, and data integrity is maintained while complying with applicable ethical and regulatory guidelines.
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