Good Clinical Practice (GCP): International quality standard provided by the International Conference on Harmonisation (ICH) that defines standards, which governments can transpose into regulations for clinical trials involving human subjects. The guidelines define the standards which trials are conducted including the roles and responsibilities of clinical trial sponsors, clinical research investigators, and monitors. They also include protection of human rights as a subject in clinical trial as well as provide assurance of the safety and efficacy of the newly developed compounds.

Health Level Seven (HL7): An all-volunteer, not-for-profit organization involved in development of international healthcare standards. “HL7” is also used to refer to some of the specific standards created by the organization (i.e. HL7 v2.x, v3.0, HL7 RIM etc.). HL7’s primary mission is to create flexible, low-cost standards, guidelines, and methodologies to enable the exchange and interoperability of electronic health records.

Good Distribution Practice: (GDP) Guidelines for the proper distribution of medicinal products for human use. GDP is a quality warranty system, which includes requirements for purchase, receiving, storage and export of drugs, intended for human consumption. GDP regulates the division and movement of pharmaceutical products from the premises of the manufacturer of medicinal products, or another central point, to the end user thereof, or to an intermediate point by means of various transport methods, via various storage and/or health establishments.

Structure product label (SPL):Defines the content of human prescription drug labeling in an XML format and is displayed in a web browser using the SPL style sheet. The use of SPL is approved by Health Level Seven (HL7) and has been adopted by FDA as a mechanism for exchanging medication information.

SPL documents: contain the content of labeling (all text, tables and figures) for a product along with drug-listing data elements. Drug-listing data elements include information about the product (product and generic names, ingredients, ingredient strengths, dosage forms, routes of administration, appearance, DEA schedule) and the packaging (package quantity and type).

Physician labeling rule (PLR): Requires that the content of labeling be organized in a specific manner with a highlights section that contains key benefit and risk information, a table of contents, the date of initial product approval, and a toll-free number and URL for reporting suspected adverse events.

21 CFR Part 11: Section of the Code of Federal Regulations that deals with the FDA guidelines on electronic records and electronic signatures in the United States. Part 11 as it is commonly called, defines the criteria under which electronic records and electronic signatures are considered to be trustworthy, reliable and equivalent to paper records. Practically speaking, Part 11 requires drug makers, medical device manufacturers, biotech companies, biologics developers, and other FDA-regulated industries (not including food manufacturers) to implement controls, including audits, validation systems, and documentation for software and systems involved in processing many forms of data as part of business operations and product development.