Objectives of the GuidelineThe main objective of this guideline is to provide harmonised principles of genomic sampling and management of genomic data in clinical studies. Scope of the GuidelineThe scope of this guideline pertains to genomic sampling and management of genomic data obtained from interventional and non-interventional clinical studies. Genomic samples and data described in this guideline are consistent with the deoxyribonucleic acid (DNA) and ribonucleic acid (RNA) characteristics defined in ICH E151. To minimize pre-analytical variation in genomic sample handling, standardized procedures for sample collection, processing, transport, and storage must be developed and documented. To properly grasp,GUIDELINE ON GENOMIC SAMPLING AND MANAGEMENT OF GENOMIC DATA E18it is advised that you read the entire guideline.