DataPlace

Medical Dictionary for Regulatory Activities. The international standard terminology for coding adverse events, indications, and medical history.

WHO Drug Dictionary & ATC/DDD classification system. The international standard for drug coding and pharmaceutical classification.

International Classification of Diseases. The global standard for classifying diseases and health conditions, widely used in diagnosis coding.

Systematized Nomenclature of Medicine — Clinical Terms. A comprehensive clinical terminology used in electronic health records (EHR).

Logical Observation Identifiers Names and Codes. An international standard for identifying laboratory results, clinical documents, and vital signs.

Common Terminology Criteria for Adverse Events. NCI standard criteria for grading adverse event severity from Grade 1 to 5.

ICH Good Clinical Practice guidelines. The international standard for the design, conduct, recording, and reporting of clinical trials.

FDA regulation on electronic records and electronic signatures. Ensures reliability, integrity, and confidentiality of electronic data.

Korean Good Clinical Practice by MFDS. Domestic clinical trial regulations based on ICH-GCP standards.

EU Clinical Trials Regulation. Governs clinical trial authorization and management in Europe through the CTIS portal.

Japan Pharmaceuticals and Medical Devices Agency guidelines. Regulations for conducting clinical trials in Japan.

China National Medical Products Administration clinical trial regulations. Standards for clinical trial approval and management in China.

CDASH, SDTM, ADaM, ODM-XML and more. Essential data structure standards required for FDA submissions.

Society for Clinical Data Management. Provides GCDMP guides and educational resources for data management professionals.

Global pharma collaboration initiative. Shares guides on eSource, Risk-Based Monitoring, and clinical trial optimization.

NIH-operated clinical trials registry database. Search and browse clinical trial information from around the world.

Clinical Trials Transformation Initiative. A Duke-FDA partnership providing research and recommendations to improve trial quality and efficiency.

Clinical Research Information Service operated by KDCA (Korea). A WHO ICTRP partner providing Korean clinical trial registration and search.