Protocol for Inventory Control and Management of Study Materials in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the management of study…
Protocol for Protocol Amendment and Change Control in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for managing changes to study protocols in…
Protocol for Standardizing Endpoint Assessment in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for endpoint adjudication in Bioavailability (BA) and Bioequivalence…
Protocol for Monitoring Study Progress and Data Quality in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to define procedures for conducting interim analysis and monitoring…
Protocol for Ensuring Insurance Protection of Study Participants Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for providing insurance coverage to participants enrolled in Bioavailability…
Protocol for Monitoring Drug Safety in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the procedures for monitoring and reporting adverse events, serious adverse…
Protocol for Managing Safety Information in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for the collection, evaluation, documentation, and reporting of safety…
Protocol for Handling Returned and Expired Drugs in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to define the procedures for the proper handling, documentation, and…
Protocol for Managing Participant Withdrawals in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for handling participant dropouts and withdrawals from Bioavailability (BA)…
Protocol for Implementing CAPA in BA/BE Study Facilities Purpose The purpose of this Standard Operating Procedure (SOP) is to define the process for identifying, implementing, and verifying corrective and preventative…