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)…

SOP for Informed Consent Process

Guidelines for Participant Consent in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to establish guidelines for obtaining informed consent from participants in Bioavailability (BA) and…

SOP for Ethical Approval of Studies

Protocol for Ethical Review in BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the process for obtaining ethical approval for Bioavailability (BA) and Bioequivalence…

SOP for Study Design Planning

Protocol for Planning BA/BE Studies Purpose The purpose of this Standard Operating Procedure (SOP) is to outline the process for planning the design of Bioavailability (BA) and Bioequivalence (BE) studies…

SOP for Study Medication Management

Standard Operating Procedure for Managing Study Medication in Clinical Research Purpose This SOP outlines the procedures for managing study medication in clinical trials and clinical studies. The goal is to…

SOP for Data Collection and Management

Standard Operating Procedure for Managing Data in Clinical Research Purpose This SOP establishes the procedures for data collection and management in clinical trials and clinical studies. The aim is to…

SOP for Participant Recruitment and Screening

Standard Operating Procedure for Recruiting and Screening Participants in Clinical Research Purpose This SOP outlines the procedures for recruiting and screening participants in clinical trials and clinical studies. The goal…

Clinical Studies: SOP for Participant Recruitment and Screening

Standard Operating Procedure for Recruiting and Screening Participants in Clinical Research Purpose The purpose of this SOP is to establish the process for recruiting and screening participants for clinical trials…

SOP for Regulatory Compliance Monitoring and Reporting

Standard Operating Procedure for Regulatory Compliance Monitoring and Reporting Purpose The purpose of this SOP is to establish procedures for monitoring regulatory compliance within the pharmaceutical distribution facility and reporting…