Source Documents. Source documents are defined as original documents, data and records. This may include hospital records, clinical and office charts, laboratory data/information, work sheets, subjects’ diaries or evaluation checklists, pharmacy dispensing and other records, recorded data from automated instruments, microfiches, photographic negatives, microfilm or magnetic media, ECG printouts, and/or x-rays. The Investigator(s)/institution(s) will permit trial-related monitoring, audits, IRB/IEC review, and regulatory inspection(s), providing direct access to source data documents.
Appears in 7 contracts
Sources: Work Statement (Radius Health, Inc.), Clinical Trial Services Agreement (Radius Health, Inc.), Clinical Trial Services Agreement (Radius Health, Inc.)