Good Clinical Practice
RSSL have the capability of conducting both sensory evaluation and consumer research studies in accordance with the Good Clinical Practice (GCP), as interpreted in ICH Harmonised Tripartite Guideline. To ensure compliance with the guideline, studies are audited by the RSSL Quality Assurance Unit (QAU). The Declaration of Helsinki and its amendments are respected at all times. RSSL obtain written approval for these tests from an appropriately constituted Ethics Committee before the start of the study. The committee requires a full written protocol, containing a detailed description of the research methodology along with full details of the formulation of each product, relevant safety data, proposed information sheets and informed consent forms, along with details of any questionnaires (Case Report Forms) which are to be used.
|