SOP for Biological Sample Management

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.…

SOP for Interim Analysis and Data Monitoring Committees

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…

SOP for Financial Management and Budgeting

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…

SOP for Study Closure and Reporting

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…

Clinical Studies: SOP for Documentation and Record-Keeping

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…

SOP for Monitoring and Auditing

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…

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…

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…

SOP for Handling Exclusion and Inclusion Criteria

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…

SOP for Subject Recruitment and Selection

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)…