Standard Operating Procedure for Managing the Investigator Site File Purpose This SOP outlines the procedures for maintaining the Investigator Site File (ISF) in clinical trials and clinical studies. The goal…
Standard Operating Procedure for Regulatory Communication Purpose This SOP outlines the procedures for communication with regulatory authorities in the context of clinical trials and clinical studies. The goal is to…
Standard Operating Procedure for Community Relations and Engagement Purpose This SOP outlines the procedures for engaging with and outreaching to the community in the context of clinical trials and clinical…
Standard Operating Procedure for SAE Reporting Purpose This SOP outlines the procedures for identifying, documenting, and reporting serious adverse events (SAEs) in clinical trials and clinical studies. The goal is…
Standard Operating Procedure for Data Analysis and Interpretation Purpose This SOP outlines the procedures for conducting statistical analysis and data interpretation in clinical trials and clinical studies. The goal is…
Standard Operating Procedure for Managing Protocol Deviations and Violations Purpose This SOP outlines the procedures for identifying, documenting, and managing protocol deviations and violations in clinical trials and clinical studies.…
Standard Operating Procedure for Participant and Investigator Masking Purpose This SOP outlines the procedures for blinding and masking in clinical trials and clinical studies. The goal is to maintain objectivity…
Standard Operating Procedure for Randomization and Participant Allocation Purpose This SOP outlines the procedures for randomization and allocation in clinical trials and clinical studies. The goal is to ensure that…
Standard Operating Procedure for Drug Safety Monitoring Purpose This SOP outlines the procedures for pharmacovigilance and drug safety monitoring in clinical trials and clinical studies. The goal is to ensure…
Protocol for Participant Monitoring after BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for conducting post-study follow-up activities with participants who have completed…