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…
Pharmacovigilance protocols
SOP for Safety Monitoring and Reporting
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…
SOP for Handling Participant Complaints and Concerns
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….
SOP for Study Medication Management
Standard Operating Procedure for Managing Study Medication in Clinical Research Purpose This SOP outlines the procedures for managing study medication in clinical trials and clinical studies. The goal is to ensure the safe, accurate, and compliant handling of study medication throughout the study. Scope This SOP applies to all personnel involved in the management of…
SOP for Data Collection and Management
Standard Operating Procedure for Managing Data in Clinical Research Purpose This SOP establishes the procedures for data collection and management in clinical trials and clinical studies. The aim is to ensure data integrity, accuracy, and compliance with regulatory requirements throughout the study. Scope This SOP applies to all personnel involved in data collection and management,…
SOP for Participant Recruitment and Screening
Standard Operating Procedure for Recruiting and Screening Participants in Clinical Research Purpose This SOP outlines the procedures for recruiting and screening participants in clinical trials and clinical studies. The goal is to ensure that recruitment and screening are conducted efficiently, ethically, and in compliance with study protocols and regulatory requirements. Scope This SOP applies to…
Clinical Studies: SOP for Participant Recruitment and Screening
Standard Operating Procedure for Recruiting and Screening Participants in Clinical Research Purpose The purpose of this SOP is to establish the process for recruiting and screening participants for clinical trials and clinical studies. This SOP ensures that the recruitment and screening process is conducted ethically and efficiently, in line with study requirements and regulatory standards….
SOP for Investigator and Site Training
Standard Operating Procedure for Training Investigators and Site Staff in Clinical Research Purpose The purpose of this SOP is to establish the process for training investigators and site staff involved in clinical trials and clinical studies. This SOP ensures that investigators and site personnel are adequately trained on study procedures, protocols, and regulatory requirements to…
SOP for Site Selection and Initiation
Standard Operating Procedure for Selecting and Initiating Clinical Research Sites Purpose The purpose of this SOP is to establish the process for selecting and initiating clinical research sites in order to ensure the success of clinical trials and clinical studies. This SOP ensures that sites are capable of conducting studies according to the study protocol,…
Clinical Studies: SOP for Informed Consent Process
Standard Operating Procedure for Obtaining Informed Consent in Clinical Research Purpose The purpose of this SOP is to establish the process for obtaining informed consent from participants in clinical trials and clinical studies. This SOP ensures that participants are provided with all necessary information to make an informed decision about their participation. Scope This SOP…