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…
Protocol for Ending BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the termination of Bioavailability (BA) and Bioequivalence (BE) studies, ensuring proper…
Protocol for Unmasking Treatment Allocation in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the handling of unblinding procedures in Bioavailability (BA)…
Protocol for Ensuring Environmental Health and Safety in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for maintaining environmental health and safety standards…
Protocol for Assessing Stability of Investigational Compounds in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the stability testing of study compounds…
Protocol for Reassessment of Analytical Results in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the reanalysis of samples in Bioavailability (BA)…