<unk>  (GCDMP) is the current industry standards for clinical<unk><unk>  that consist of best business practice and acceptable regulatory standards. In all phases of clinical trials, clinical and laboratory information must be collected and converted to digital form for analysis and reporting purposes. The U.S. Food and Drug Administration and International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use have provided specific regulations and guidelines surrounding this component of the drug and device development process. The effective, efficient and regulatory-compliant<unk>  of clinical trial<unk>  is an essential component of drug and device development. The Society for Clinical<unk><unk>  (SCDM) has created the<unk> s (GCDMP©) standard, a comprehensive document that provides guidance on accepted practices of clinical<unk><unk>  (CDM) that are not totally covered by current guidelines and regulations. This document is updated by Subject Matter Experts on a continuous basis.
Good clinical data management practice
Good clinical practice
Patient group directions
Clinical research ethics
Good clinical laboratory practice
Guidances for statistics in regulatory affairs
Patient safety organization
Glossary of clinical research