SOP for Randomization and Blinding

Procedure for Randomization and Masking in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the randomization and blinding processes in Bioavailability (BA)…

SOP for Vendor and Third-Party Management

Standard Operating Procedure for Managing Vendors and Third Parties in Clinical Research Purpose This SOP outlines the procedures for the selection, engagement, oversight, and evaluation of vendors and third parties…

SOP for Conflict of Interest Management

Standard Operating Procedure for Identifying and Managing Conflicts of Interest in Clinical Research Purpose This SOP outlines the procedures for identifying, assessing, and managing conflicts of interest (COI) in clinical…

Clinical Studies: SOP for Emergency Preparedness and Response

Standard Operating Procedure for Managing Emergencies in Clinical Research Purpose This SOP outlines the procedures for emergency preparedness and response in clinical trials and clinical studies. The goal is to…

SOP for Confidentiality and Privacy

Standard Operating Procedure for Maintaining Participant Confidentiality and Privacy in Clinical Research Purpose This SOP outlines the procedures for ensuring the confidentiality and privacy of participant data in clinical trials…

SOP for Participant Compensation and Reimbursement

Standard Operating Procedure for Compensating and Reimbursing Participants in Clinical Research Purpose This SOP outlines the procedures for compensating and reimbursing participants in clinical trials and clinical studies. The goal…

SOP for Risk Management and Mitigation

Standard Operating Procedure for Managing and Mitigating Risks in Clinical Trials Purpose This SOP outlines the procedures for risk management and mitigation in clinical trials and clinical studies. The goal…

SOP for Project Management and Coordination

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…

Clinical Studies: SOP for Participant Compensation and Reimbursement

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…

SOP for Access to Study Data and Records

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…