Regulations

Regulations

Fundamental Clinical Research Guidelines

All research studies performed at SEC Clinical Research adhere to clinical research guidelines defined by federal and international codes and regulations. Good Clinical Practice is the core of standards followed by SEC Clinical Research, which is a summary of international standards to be followed in the conduct of clinical research.

The Good Clinical Practice (GCP) guidelines address the following essential aspects of clinical research:

  1. Optimize safety and protections for all participants in clinical research
  2. Define the role and responsibilities of investigators and staff conducting clinical research
  3. Define the components required in a research protocol, which is the document that describes what and how a specific research study will be performed

At SEC Clinical Research, all of our investigators, and all staff having contact with research participants, are required to take and pass an annual GCP certification course.

Specific Research Study Guidelines

Every research study performed at SEC Clinical Research follows a “research protocol” that details every aspect of the specific research study. Protocols have specific inclusion and exclusion criteria that are a listing of features research volunteers should have (inclusion) or not have (exclusion). For example, a common inclusion criteria is an age range: “Subjects must be between the ages of 40 – 80.” A typical exclusion is a coexisting medical condition or history: “Subjects with a history of cancer within the past five years.” The protocol dictates how, when and what procedures, testing, and medications will be performed, and length of the study. Since clinical research studies require multiple sites at different locations, including different countries, in order to enroll the large numbers of volunteers typically required, having all of the sites follow the same detailed protocol permits the research results from many subjects around the country and world to be combined an analyzed as if all were performed at a single location.