GCP & More

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Do I Need to More than GCP?

Clinical research is more than just understanding the requirements of Good Clinical Practices (GCP) and it's more thatn just understanding the regulatory requirements. It is about effectively putting all of it together.

GCP Training: Essentials of Fundamentals

Several doctors that have never been trained in GCP may get a research study to participate in. Typically, a sales rep from a pharmaceutical company (or a medical liasion) will inform you of an upcoming trial. But training...makes the difference. Proper training allows you to address problems before they arise and provide the need information that the sponsor requires on-time.

Informed Consent Process and Study Participant Recruitment

The process of obtaining informed consent must comply with the requirements of 45 CFR 46.116. The documentation of informed consent must comply with 45 CFR 46.117. The following comments may help in the development of an approach and proposed language by investigators for obtaining consent and its approval by IRBs:

  • Informed consent is a process, not just a form. Information must be presented to enable persons to voluntarily decide whether or not to participate as a research subject. It is a fundamental mechanism to ensure respect for persons through provision of thoughtful consent for a voluntary act.

Subject recruitment is a critical and necessary component for the advancement of science and a research study. Investigators are expected to identify and enroll in their research study. Sephmer assists investigators with recruitment strategies for clinical trials.

Clinical Trials: More Just People

Investigators are required to file regulatory documents and keep records for a clinical trial:

  • Regulatory Binder and Checklist
  • Source Documentation and Guidelines
  • Case Report Form (CRF) Notebook
  • Study Closeout
  • Clinical Laboratory Certification

Clinical Laboratory certification is a protocol-specific requirement for clinical research. The certificates are provided by College of American Pathologists (CAP) or the Clinical Laboratory Improvement Amendments Program (CLIA) through the Centers for Medicare and Medicaid Services (CMS).