The Ultimate Resource for Pharmaceutical SOPs and Best Practices
Standard Operating Procedure for Ensuring Participant Follow-Up and Retention in Clinical Research Purpose This SOP outlines the procedures for conducting follow-up with participants and ensuring their retention in clinical trials and clinical studies. The goal is to maintain high levels of participant engagement, adherence, and retention to support study integrity and data quality. Scope This…
Standard Operating Procedure for Training and Certifying Clinical Study Staff Purpose This SOP outlines the procedures for training and certifying study personnel involved in clinical trials and clinical studies. The goal is to ensure that all staff have the necessary knowledge and skills to conduct the study in compliance with protocols, regulations, and ethical standards….
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Standard Operating Procedure for Ensuring Participant Follow-Up and Retention in Clinical Research Purpose This SOP outlines the procedures for conducting follow-up with participants and ensuring their retention in clinical trials and clinical studies. The goal is to maintain high levels of participant engagement, adherence, and retention to support study integrity and data quality. Scope This…
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Standard Operating Procedure for Ensuring Data Integrity and Compliance in Clinical Research Purpose This SOP outlines the procedures for ensuring data integrity and compliance in clinical trials and clinical studies. The goal is to maintain high standards of data quality, accuracy, and consistency while adhering to regulatory requirements. Scope This SOP applies to all personnel…
Standard Operating Procedure for Compliance with Regulatory and Ethical Requirements in Clinical Research Purpose This SOP outlines the procedures for ensuring regulatory and ethical compliance in clinical trials and clinical studies. The goal is to maintain adherence to all applicable laws, regulations, guidelines, and ethical standards throughout the study. Scope This SOP applies to all…
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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