Trusted Resource for Clinical Trials, Protocols & Progress
The purpose of this SOP is to define procedures for handling audit reports and integrating Corrective and Preventive Actions (CAPA) in clinical trials. Proper documentation and CAPA management ensure that audit findings are addressed in a timely and effective manner, safeguarding subject safety, data integrity, and regulatory compliance.
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To establish standardized, regulatory-compliant processes that ensure continuous inspection readiness at investigator sites and at sponsor/CRO level. This SOP defines proactive measures for maintaining the Trial Master File (TMF) and Investigator Site File (ISF), preparing personnel, coordinating vendor support, staging records for rapid retrieval, and executing structured responses before, during, and after regulatory inspections by agencies such as CDSCO, US FDA, EMA, MHRA, PMDA, and WHO-prequalification programs.
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The purpose of this SOP is to define standardized processes for managing regulatory inspections conducted by agencies such as US FDA, EMA, CDSCO, MHRA, PMDA, and WHO. It ensures that sponsor, CRO, and site staff are prepared, that inspections are handled professionally, and that responses and CAPA to inspection findings are managed within mandated timelines.
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The purpose of this SOP is to describe the standardized setup, structure, and maintenance of the Trial Master File (TMF), whether maintained in paper format or electronic format (eTMF). TMF serves as the central repository of essential documents demonstrating compliance with Good Clinical Practice (GCP) and enabling evaluation by regulatory authorities.
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The purpose of this SOP is to establish a standardized process for contemporaneous filing of essential documents into the Trial Master File (TMF) during the conduct of a clinical trial. This ensures that all trial-related records are accurate, complete, current, and readily available for inspection by regulatory authorities.
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The purpose of this SOP is to describe the management, filing, and verification of essential documents required before the initiation of a clinical trial, in accordance with ICH E6 §8, GCP, and global regulatory authority expectations. These documents collectively demonstrate trial preparation, regulatory compliance, and readiness for initiation.
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The purpose of this SOP is to define the process for collecting, filing, and maintaining essential documents during the conduct of a clinical trial, as per ICH E6 §8 requirements. These documents collectively enable the evaluation of trial conduct and ensure compliance with GCP, regulatory expectations, and subject protection.
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The purpose of this SOP is to define standardized procedures for collecting, filing, and archiving essential documents after the completion of a clinical trial. These records demonstrate that the trial was conducted in compliance with GCP, regulatory requirements, and ethical standards, and that data generated is credible and verifiable.
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The purpose of this SOP is to define processes for managing access, permissions, and security of Trial Master Files (TMF/eTMF), ensuring that only authorized personnel have appropriate access in compliance with ICH GCP, 21 CFR Part 11, EMA Annex 11, CDSCO, and WHO requirements.
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The purpose of this SOP is to establish standardized processes for archiving and retaining Trial Master Files (TMF/eTMF) in compliance with multi-regional requirements. Proper archiving ensures that essential documents are preserved, secure, accessible, and inspection-ready for the retention period defined by regulatory authorities such as FDA, EMA, CDSCO, MHRA, PMDA, and WHO.
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