The Ultimate Resource for Pharmaceutical SOPs and Best Practices
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 Bioequivalence (BE) studies in the pharmaceutical industry. Scope This SOP applies to all personnel involved in the recruitment, enrollment, and consent process of study participants,…
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 (BE) studies in the pharmaceutical industry. Scope This SOP applies to all personnel involved in the planning, conduct, and oversight of BA and BE studies,…
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 in the pharmaceutical industry. Scope This SOP applies to all personnel involved in the planning, conduct, and oversight of BA and BE studies, including Principal…
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 ensure the safe, accurate, and compliant handling of study medication throughout the study. Scope This SOP applies to all personnel involved in the management of…
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 ensure data integrity, accuracy, and compliance with regulatory requirements throughout the study. Scope This SOP applies to all personnel involved in data collection and management,…
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 is to ensure that recruitment and screening are conducted efficiently, ethically, and in compliance with study protocols and regulatory requirements. Scope This SOP applies to…
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 and clinical studies. This SOP ensures that the recruitment and screening process is conducted ethically and efficiently, in line with study requirements and regulatory standards….
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Standard Operating Procedure for Training Investigators and Site Staff in Clinical Research Purpose The purpose of this SOP is to establish the process for training investigators and site staff involved in clinical trials and clinical studies. This SOP ensures that investigators and site personnel are adequately trained on study procedures, protocols, and regulatory requirements to…
Standard Operating Procedure for Selecting and Initiating Clinical Research Sites Purpose The purpose of this SOP is to establish the process for selecting and initiating clinical research sites in order to ensure the success of clinical trials and clinical studies. This SOP ensures that sites are capable of conducting studies according to the study protocol,…
Standard Operating Procedure for Obtaining Informed Consent in Clinical Research Purpose The purpose of this SOP is to establish the process for obtaining informed consent from participants in clinical trials and clinical studies. This SOP ensures that participants are provided with all necessary information to make an informed decision about their participation. Scope This SOP…
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