The Ultimate Resource for Pharmaceutical SOPs and Best Practices
Standard Operating Procedure for Project Management in Clinical Trials Purpose This SOP outlines the procedures for project management and coordination in clinical trials and clinical studies. The goal is to ensure the effective planning, execution, and completion of clinical projects in accordance with study protocols and regulatory requirements. Scope This SOP applies to all personnel…
Standard Operating Procedure for Compensating and Reimbursing Clinical Trial Participants Purpose This SOP outlines the procedures for compensating and reimbursing participants in clinical trials and clinical studies. The goal is to ensure participants are fairly compensated for their time and effort and reimbursed for any study-related expenses in a timely manner. Scope This SOP applies…
Read More “Clinical Studies: SOP for Participant Compensation and Reimbursement” »
Standard Operating Procedure for Data and Record Accessibility Purpose This SOP outlines the procedures for managing access to study data and records in clinical trials and clinical studies. The goal is to ensure that access to data and records is controlled, secure, and granted only to authorized personnel for legitimate study-related purposes. Scope This SOP…
Standard Operating Procedure for Management of Regulatory Documentation Purpose This SOP outlines the procedures for maintaining regulatory documents in clinical trials and clinical studies. The goal is to ensure accurate, organized, and secure maintenance of regulatory documentation to support compliance with applicable regulations and study-specific requirements. Scope This SOP applies to all personnel involved in…
Standard Operating Procedure for Closing Out Sites and Terminating Clinical Studies Purpose This SOP outlines the procedures for conducting site close-out and study termination in clinical trials and clinical studies. The goal is to ensure that sites are closed properly and that all study activities are concluded in compliance with regulatory, ethical, and study-specific requirements….
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….
Read More “SOP for Training and Certification of Study Personnel” »
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…
Read More “Clinical Studies: SOP for Participant Follow-Up and Retention” »
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…