Standard Operating Procedures (SOPs) in Clinical Trials are the standard documents that define the procedure, which must be followed to ensure that standards are followed while carrying out research. These SOP’s help the research teams, as recommendations for conducting research in the appropriate manner. They clearly outline the step by step procedure to be followed on various topics concerned with clinical research in question.
Here is the list of 5 Important Standard Operating Procedures (SOPs) in Clinical Trials.
Standard Operating Procedure for Preparing, Maintaining and Training:
This is the most primary SOP as it helps in preparing, maintaining, numbering and formatting SOPs. It helps the research team to prepare SOP’s that comply with the guidelines set by GCP and FDA.
Standard Operating Procedure for Responsibilities Of The Research Team:
This SOP defines the responsibilities of the research team, that all conditions defined by FDA on the use of investigational articles are followed. The principal investigator acts as the head of the team and is responsible for implementing the guidelines.
Standard Operating Procedure for Training and Education:
This SOP defines the standard training procedures that must be adopted to ensure that clinical research is carried out in a responsible manner. The purpose of the SOP is to define guidelines for good clinical practice in compliance with FDA.
Standard Operating Procedure for Assessing Protocol Feasibility:
All clinical trials need to comply with certain ethical and scientific procedures. It is important to access the ethical, scientific and financial advantages that can be drawn from the trials. This SOP helps in determining the feasibility of protocols in a trial and also setting up protocols that can take care of ethical, medical and regulatory requirements.
Standard Operating Procedure for Pre-study Site Visit:
This SOP is defined to help the sponsor in analyze the study site in view of facilities, implementation and feasibility.
Standard Operating Procedures make it easier for the research team to carry out trials in compliance with the standards set by FDA or other standard organizations.