The Ultimate Resource for Pharmaceutical SOPs and Best Practices
Standard Operating Procedure for Handling, Storage, and Processing of Biological Samples in Clinical Research Purpose This SOP outlines the procedures for managing biological samples in clinical trials and clinical studies. The goal is to ensure the integrity and quality of biological samples while maintaining compliance with ethical and regulatory standards. Scope This SOP applies to…
Standard Operating Procedure for Conducting Interim Analyses and Utilizing Data Monitoring Committees in Clinical Research Purpose This SOP outlines the procedures for conducting interim analyses and utilizing data monitoring committees (DMCs) in clinical trials and clinical studies. The goal is to ensure participant safety, study integrity, and data quality through regular review and oversight. Scope…
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Standard Operating Procedure for Managing Finances and Budgeting in Clinical Research Purpose This SOP outlines the procedures for financial management and budgeting in clinical trials and clinical studies. The goal is to ensure efficient and transparent use of funds while maintaining compliance with financial regulations and study protocols. Scope This SOP applies to all personnel…
Standard Operating Procedure for Closing and Reporting Clinical Research Studies Purpose This SOP outlines the procedures for closing a clinical trial or clinical study and reporting the results. The goal is to ensure a systematic, organized, and compliant study closure process and accurate reporting of study findings. Scope This SOP applies to all personnel involved…
Standard Operating Procedure for Record-Keeping in Clinical Research Purpose This SOP establishes the procedures for documentation and record-keeping in clinical trials and clinical studies. The goal is to ensure the maintenance of accurate, complete, and up-to-date records in compliance with regulatory requirements and Good Clinical Practice (GCP) standards. Scope This SOP applies to all personnel…
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Standard Operating Procedure for Monitoring and Auditing in Clinical Research Purpose This SOP outlines the procedures for monitoring and auditing in clinical trials and clinical studies. The goal is to ensure study compliance with protocols, regulatory requirements, and good clinical practice (GCP) standards. Scope This SOP applies to all personnel involved in monitoring and auditing…
Standard Operating Procedure for Monitoring and Reporting Safety in Clinical Research Purpose This SOP outlines the procedures for safety monitoring and reporting in clinical trials and clinical studies. The aim is to ensure participant safety, promptly identify and manage adverse events, and comply with regulatory reporting requirements. Scope This SOP applies to all personnel involved…
Standard Operating Procedure for Addressing Participant Feedback and Issues in Clinical Research Purpose This SOP outlines the procedures for receiving, investigating, and resolving participant complaints and concerns in clinical trials and clinical studies. The goal is to ensure participants feel heard and supported, maintain trust in the research process, and promote ethical and high-quality studies….
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Procedure for Defining Study Participant Criteria Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for defining and implementing exclusion and inclusion criteria for selecting participants in Bioavailability (BA) and Bioequivalence (BE) studies in the pharmaceutical industry. Scope This SOP applies to all personnel involved in the development, review, and implementation…
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Protocol for Participant Recruitment in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the recruitment and selection of participants in Bioavailability (BA) and Bioequivalence (BE) studies in the pharmaceutical industry. Scope This SOP applies to all personnel involved in the recruitment and selection process, including Principal Investigators,…