Standard Operating Procedures (SOPs) is a written document of instructions to perform different processes based on the company´s needs. It provides a step-by-step method to ensure consistency, accuracy and quality of a company’s processes, a formula of safe conduct and a legal document for those who use it. It is the pillar of all quality work.

 SOPs are required to allow the company to continue growing on an organized and solid structure to establish a succession plan and train the growing employee base.

SOPs will be organized in sections, according to the activities each employee is involved. Additionally, each SOP will identify which department is affected by it.

This refresher course ensures compliance and proficiency in using the platform for study conduct/eReg. Participants will learn to navigate the platform, manage documents, access patient and visit information, manage regulatory documents, sign trainings and documents.

This course provides a thorough overview of the informed consent process and Good Documentation Practices (GDP) in clinical research. It emphasizes ethical standards, regulatory compliance (ICH-GCP, FDA), and participant rights. The training includes step-by-step guidance on preparing for and conducting informed consent discussions, handling special populations (e.g., minors, LARs, non-English speakers), and avoiding common errors. It also covers ALCOA+ principles of documentation to ensure accuracy, integrity, and traceability in clinical trial records.

This refresher course ensures compliance and proficiency in using the platform for study conduct. Participants will learn to navigate the platform, manage documents, access patient and visit information, and respond to quality control findings.

This course provides a step-by-step overview of handling investigational product (IP) at the site—from shipment receipt and temperature monitoring (Temp-Tale), through documentation in IWRS/IPAL and dispensing (including remote pharmacist verification), to return and destruction of IP—ensuring full accountability and compliance with SOP requirements and Pharmacy Manual.

This refresher course ensures compliance and proficiency in using the platform for study conduct. Participants will learn to navigate the platform, manage documents, access patient and visit information, and respond to quality control findings.

This training is designed to introduce and reinforce knowledge of medical terminology for newly hired personnel.

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Documentation of applicable meetings, calls, trainings, etc. 

By: Lizandro Loor. 

Standard Operating Procedures (SOPs) is a written document of instructions to perform different processes based on the company´s needs. It provides a step-by-step method to ensure consistency, accuracy and quality of a company’s processes, a formula of safe conduct and a legal document for those who use it. It is the pillar of all quality work.

 SOPs are required to allow the company to continue growing on an organized and solid structure to establish a succession plan and train the growing employee base.