Healthcare has a very detailed and strict regulations.
These are mostly the same as the still growing regulations as with commercial business. A lot is added to as this is a dedicated domain.
The Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments. The FDA is responsible for protecting and promoting public health through the regulation and supervision of food safety, tobacco products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines, biopharmaceuticals, blood transfusions, medical devices, electromagnetic radiation emitting devices (ERED), veterinary products, and cosmetics.
is related to HHS
A lot of information and regulations.
CDISC mainly consists of the following:
- Study Data Tabulation Model(SDTM)
Electronic Data Capture(EDC) and Electronic Case Report Form(eCRF) annotation
- Analysis Data Model(ADaM)
- Operational Data Model(ODM)
XML programming knowledge
- Laboratory Data Model(LAB)
Conversion of external data to
- Case Report Tabulation Data Define Specification(CRTDDS) – Define.xml
Metadata of SDTM and ADaM and XML programming knowledge
- Protocol Representation(PR)
- Trial Design Model(TDM)
Statistical Analysis Plan(SAP) and SDTM
- Clinical Data Acquisition Standards Harmonization(CDASH)
Introduction to the CDISC Standards
The Clinical Data Interchange Standards Consortium (CDISC) encompasses a suite of standards across the clinical space. The Study Data Tabulation Model (SDTM) and Analysis Data Model (ADaM) are probably the two standards
most familiar to PharmaSUG attendees, but there are many others. This paper and presentation focus on the foundational standards of CDISC, from protocol to analysis reporting, along with data exchange and controlled
terminology. Each of these standards is introduced, emphasizing how it fits into the big picture. Whether you want to discover these standards that are quickly becoming common place in our industry, or just add a few acronyms (PRM,
CDASH, SDTM, SEND, ADaM, ODM, and NCI EVS) to your vocabulary, then this is for you!
The word mock tables is introduced as where a logical metadata design with accoding tooling is used in a dbms approach
A .... Application to Create Mock Tables in Statistical Analysis Plans for Phase I Clinical Studies
Good statistical practice dictates that a Statistical Analysis Plan (SAP) should be prepared for clinical studies (ICH E6, E9; references 1 and 2). The SAP describes statistical methods planned in more detail than in the study protocol and will include descriptions and mocks of the statistical data summaries. The mock tables focus on the layout of the rows and columns of each table and show arbitrary symbols such as an “X” to represent the unknown, future data.
Although this macro could be used for any clinical study,
standars to software
is an open standard specification in health informatics that describes the management and storage, retrieval and exchange of health data in electronic health records (EHRs).
In openEHR, all health data for a person is stored in a "one lifetime", vendor-independent, person-centred EHR. The openEHR specification is not concerned with the exchange of data between EHR-systems as this is the primary focus of other standards such as EN 13606 and HL7.
HL7 Health Level Seven (HL7), is a non-profit organization involved in the development of international healthcare informatics interoperability standards. "HL7" also refers to some of the specific standards created by the organization
EN 13606 The overall goal of this Health informatics - Electronic Health Record Communication (EN 13606) European Standard is to define a rigorous and stable information architecture for communicating part or all of the Electronic Health Record (EHR) of a single subject of care (patient).