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Standard Operating Procedures for
Good Clinical Practices

Introduction

Clinical research has grown over the last fifty years from an Investigator-driven, informal activity to a multi-billion dollar global business, intensely, regulated and controlled by the federal government.  Biomedical research requires specialized knowledge, which includes regulatory requirements, Good Clinical Practice (GCP) and medical ethics.

The Food and Drug Administration (FDA) regulations and the Health and Human Services (HHS) Common Rule regulations define the fundamental requirements of GCP – “A standard for the design, conduct, performance, monitoring, auditing recording, analyses, and reporting of clinical trials that provides assurance that the data and reported results are credible and accurate, and that the rights, integrity, and confidentiality of trial subjects are protected.”  These regulations are built as first described in the Nuremburg Code, and later adopted and enhanced by the World Medical Assembly in the Declaration of Helsinki and the United States in the Belmont Report.  When combined, these concepts serve as the gold standard in the practice of clinical research.

In recent years, the United States, European Union, and Japan came together at the International Conference on Harmonization (ICH) to develop global standards for the conduct of clinical research.  The purpose of ICH is to harmonize the approach of various countries regulatory requirements for the conduct of scientifically sound, ethical research and facilitate mutual acceptance of data submitted in support of drug marketing applications.  Their GCP guideline has been adopted by industry and academia worldwide. 

It is the responsibility of the clinical research investigator, and by extension the investigator’s institution, to nurture an institutional culture where studies are conducted in an ethical and scientifically rigorous manner, and where there is a focus on safeguards for the protection of subjects who participate in clinical studies.  Standard Operating Procedures are an important tool in defining the institutional approach to nurturing GCP standards and research regulatory compliance.

The organization of this SOP Manual is intended to group together related activities and/or concepts.  Each individual SOP is numbered with the group abbreviation and a sequential number to facilitate categorizing the particular SOP.

This SOP Manual also contains an extensive library of attachments, checklists, logs and other forms.  These tools are not required (with just a few exceptions), but are available as a resource for investigative teams to use as is, revise, or serve as examples for the design of their own forms and templates.  There are a few forms that must be used as designed and will be described as such.

This SOP Manual serves as an important tool for the implementation of GCP standards and for nurturing an institutional culture of research excellence.  These SOPs must be read, understood and used by all staff in the conduct of clinical research.  Periodic review and updating will ensure this SOP Manual remains a living, useful document in support of research subject safety and data integrity at Thomas Jefferson University.