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TX: CodeSystem v4-ICHContextOfUse

Properties

Defining URL http://terminology.hl7.org/CodeSystem/ICHContextOfUse
Name ICHContextOfUse
Title ICH Context of Use
Status active
Definition

Codes are found within the vocabulary package at the link above which is available from this page: https://ich.org/page/ich-electronic-common-technical-document-ectd-v40 . Specifically, the codes are in the “ICH Context of Use” tab of the "ICH M8 OID Listing_eCTDv4_v5.xlsx" workbook. The codes are part of the ICH implementation of HL7 V3 Standard: Regulated Studies; Regulated Product Submissions (RPS), Release 2 Normative (described here: https://www.hl7.org/implement/standards/product_brief.cfm?product_id=38 )

When using this uri in FHIR, the version identifier is mandatory and the code system uri cannot be used without it.

This system uses an integer based versioning system in conjunction with an OID update. For example, if the version of the system is v5, the OID is 2.16.840.1.113883.3.989.2.2.1.1.5. This system has an OID stem of 2.16.840.1.113883.3.989.2.2.1.1.
Publisher International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
Copyright "The information, material and photographic content provided on this website are protected by copyright and may, with the exception of the ICH logo, be used, reproduced, incorporated into other works, adapted, modified, translated or distributed under a public license provided that ICH's copyright in the information and material is acknowledged at all times. In case of any adaption, modification or translation of the information, material or photographic content, reasonable steps must be taken to clearly label, demarcate or otherwise identify that changes were made to or based on the original information or material. Any impression that the adaption, modification or translation of the original information or material is endorsed or sponsored by the ICH must be avoided." For more information, see [https://ich.org/page/legal-mentions](https://ich.org/page/legal-mentions)

This case-sensitive code system http://terminology.hl7.org/CodeSystem/ICHContextOfUse provides a fragment that includes following codes:

Code Display
ich_3.2.p.4.5 m3.2.p.4.5 excipients of human or animal origin
ich_3.2.s m3.2.s drug substance
ich_3.2.p.3.2 m3.2.p.3.2 batch formula
ich_2.7.5 m2.7.5 literature references
ich_3.2.p.2 m3.2.p.2 pharmaceutical development
ich_4.2.3.4.1 m4.2.3.4.1 long-term studies
ich_3.2.p.4.3 m3.2.p.4.3 validation of analytical procedures
ich_2.4 m2.4 nonclinical overview
ich_3.2.a.2 m3.2.a.2 adventitious agents safety evaluation
ich_3.2.p.8.2 m3.2.p.8.2 post-approval stability protocol and stability commitment
ich_3.2.s.2.4 m3.2.s.2.4 controls of critical steps and intermediates
ich_2.6.7 m2.6.7 toxicology tabulated summary
ich_3.2.p.2.1 m3.2.p.2.1 components of the drug product
ich_4.2.1.1 m4.2.1 1 primary pharmacodynamics
ich_2.3.p m2.3.p drug product
ich_3.2.s.2.3 m3.2.s.2.3 control of materials
ich_2.3.a.2 m2.3.a.2 adventitious agents safety evaluation
ich_4.2.2.4 m4.2.2.4 metabolism
ich_4.2.2.7 m4.2.2.7 other pharmacokinetic studies
ich_5.3.2.3 m5.3.2.3 reports of studies using other human biomaterials
ich_4.2.3.7.3 m4.2.3.7.3 mechanistic studies
ich_5.3.3.4 m5.3.3.4 extrinsic factor pk study reports
ich_3.2.s.1 m3.2.s.1 general information
ich_5.3.5.3 m5.3.5.3 reports of analyses of data from more than one study
ich_2.6.5 m2.6.5 pharmacokinetics tabulated summary
ich_4.3 m4.3 literature references
ich_4.2.1.2 m4.2.1 2 secondary pharmacodynamics
ich_3.2.a.1 m3.2.a.1 facilities and equipment
ich_3.2.p.4 m3.2.p.4 control of excipients
ich_4.2.2.2 m4.2.2 2 absorption
ich_3.2.a m3.2.a appendices
ich_3.2.p.4.1 m3.2.p.4.1 specifications
ich_2.6.3 m2.6.3 pharmacology tabulated summary
ich_3.2.p.2.5 m3.2.p.2.5 microbiological attributes
ich_2.7.4 m2.7.4 summary of clinical safety
ich_5.3.6 m5.3.6 reports of postmarketing experience
ich_3.2.p.2.4 m3.2.p.2.4 container closure system
ich_2.6.1 m2.6.1 introduction
Ich_2 m2 common technical document summaries
ich_4.2.3.1 m4.2.3.1 single-dose toxicity
ich_3.2.s.7.1 m3.2.s.7.1 stability summary and conclusions
ich_4.2.1.4 m4.2.1 4 pharmacodynamic drug interactions
ich_4.2.3.7.6 m4.2.3.7.6 impurities
ich_3.2.s.2.6 m3.2.s.2.6 manufacturing process development
ich_4.2.3.5.2 m4.2.3.5.2 embryofetal development
ich_3.2.p.2.6 m3.2.p.2.6 compatibility
ich_3.2.p.8.3 m3.2.p.8.3 stability data
ich_5.3.1.4 m5.3.1 4 reports of bioanalytical and analytical methods for human studies
ich_3.2.p.2.3 m3.2.p.2.3 manufacturing process development
ich_3.2.p.3.5 m3.2.p.3.5 process validation and/or evaluation
ich_5.3.3.3 m5.3.3 3 intrinsic factor pk study reports
ich_5.3.5.2 m5.3.5.2 study reports of uncontrolled clinical studies
ich_5.3.4.1 m5.3.4.1 healthy subject pd and pk/pd study reports
ich_4.2.2.5 m4.2.2.5 excretion
ich_3.2.p.5.2 m3.2.p.5.2 analytical procedures
ich_3.2.s.2.5 m3.2.s.2.5 process validation and/or evaluation
ich_5.3.2.1 m5.3.2.1 plasma protein binding study reports
ich_2.3.r m2.3.r regional information
ich_3.2.s.3.2 m3.2.s.3.2 impurities
ich_4.2.3.3.2 m4.2.3.3.2 in vivo
ich_2.3.i m2.3 introduction
ich_3.2.s.2.2 m3.2.s.2.2 description of manufacturing process and process controls
ich_3.2.s.2.1 m3.2.s.2.1 manufacturer(s)
ich_3.2.p.5.4 m3.2.p.5.4 batch analyses
ich_3.2.p.3.1 m3.2.p.3.1 manufacturer(s)
ich_2.5 m2.5 clinical overview
ich_3.2.s.3 m3.2.s.3 characterisation
ich_3.2.s.5 m3.2.s.5 reference standards or materials
ich_2.6.2 m2.6.2 pharmacology written summary
ich_3.2.s.4.2 m3.2.s.4.2 analytical procedures
ich_3.2.s.3.1 m3.2.s.3.1 elucidation of structure and other characteristics
ich_3.2.s.4.5 m3.2.s.4.5 justification of specification
ich_5.3.2.2 m5.3.2.2 reports of hepatic metabolism and drug interaction studies
ich_4.2.2.6 m4.2.2.6 pharmacokinetic drug interactions
ich_3.2.p.5.5 m3.2.p.5.5 characterisation of impurities
ich_3.2.s.4.4 m3.2.s.4.4 batch analyses
ich_4.2.3.6 m4.2.3.6 local tolerance
ich_3.2.s.2 m3.2.s.2 manufacture
ich_3.2.p.4.2 m3.2.p.4.2 analytical procedures
ich_4.2.3.7.7 m4.2.3.7.7 other
ich_5.3.1.1 m5.3.1 1 bioavailability study reports
ich_5.3.1.2 m5.3.1 2 comparative ba and bioequivalence study reports
ich_2.3.s m2.3.s drug substance
ich_4.2.3.7.5 m4.2.3.7.5 metabolites
ich_3.2.s.4.1 m3.2.s.4.1 specification
ich_3.2.p.2.2 m3.2.p.2.2 drug product
ich_3.2.p.4.6 m3.2.p.4.6 novel excipients
ich_5.3.5.1 m5.3.5.1 study reports of controlled clinical studies pertinent to the claimed indication
ich_3.2.s.7.3 m3.2.s.7.3 stability data
ich_3.2.p.5.3 m3.2.p.5.3 validation of analytical procedures
ich_5.2 m5.2 tabular listing of all clinical studies
ich_2.7.1 m2.7.1 summary of biopharmaceutic studies and associated analytical methods
ich_4.2.3.3.1 m4.2.3.3.1 in vitro
ich_3.2.p.3 m3.2.p.3 manufacture
ich_2.3.a.1 m2.3.a.1 facilities and equipment
ich_4.2.2.3 m4.2.2.3 distribution
ich_4.2.3.2 m4.2.3.2 repeat-dose toxicity
ich_2.6.4 m2.6.4 pharmacokinetics written summary
ich_4.2.3.4.2 m4.2.3.4.2 short or medium-term studies
ich_4.2.3.5.1 m4.2.3.5.1 fertility and early embryonic development
ich_3.2.p.1 m3.2.p.1 description and composition of the drug product
ich_4.2.3.5.4 m4.2.3.5.4 studies in which the offspring juvenile animals are dosed and/or further evaluated
ich_5.4 m5.4 literature references
ich_3.3 m3.3 literature references
ich_5.3.3.5 m5.3.3.5 population pk study reports
ich_3.2.p.3.3 m3.2.p.3.3 description of manufacturing process and process controls
ich_5.3.4.2 m5.3.4.2 patient pd and pk/pd study reports
ich_2.7.2 m2.7.2 summary of clinical pharmacology studies
ich_2.3 m2.3 quality overall summary
ich_3.2.p.7 m3.2.p.7 container closure system
ich_3.2.p m3.2.p drug product
ich_3.2.p.6 m3.2.p.6 reference standards or materials
ich_2.3.a.3 m2.3.a.3 excipients
ich_3.2.s.4 m3.2.s.4 control of drug substance
ich_3.2.p.3.4 m3.2.p.3.4 controls of critical steps and intermediates
ich_5.3.1.3 m5.3.1 3 in vitro in vivo correlation study reports
ich_4.2.3.5.3 m4.2.3.5.3 prenatal and postnatal development, including maternal function
ich_5.3.7 m5.3.7 case report forms and individual patient listings
ich_3.2.a.3 m3.2.a.3 excipients
ich_5.3.3.2 m5.3.3.2 patient pk and initial tolerability study reports
ich_3.2.p.8 m3.2.p.8 stability
ich_2.6.6 m2.6.6 toxicology written summary
ich_3.2.s.4.3 m3.2.s.4.3 validation of analytical procedures
ich_4.2.2.1 m4.2.2.1 analytical methods and validation reports
ich_4.2.3.7.2 m4.2.3.7.2 immunotoxicity
ich_5.3.3.1 m5.3.3.1 healthy subject pk and initial tolerability study reports
ich_5.3.5.4 m5.3.5.4 other study reports
ich_3.2.s.7.2 m3.2.s.7.2 post-approval stability protocol and stability commitment
ich_2.7.6 m2.7.6 synopses of individual studies
ich_4.2.3.7.1 m4.2.3.7.1 antigenicity
ich_2.2 m2.2 introduction
ich_3.2.p.5.6 m3.2.p.5.6 justification of specifications
ich_3.2.p.8.1 m3.2.p.8.1 stability summary and conclusion
ich_3.2.r m3.2 r regional information
ich_4.2.3.4.3 m4.2.3.4.3 other studies
ich_3.2.p.5 m3.2.p.5 control of drug product
ich_2.7.3 m2.7.3 summary of clinical efficacy
ich_4.2.1.3 m4.2.1 3 safety pharmacology
ich_3.2.p.4.4 m3.2.p.4.4 justification of specifications
ich_4.2.3.7.4 m4.2.3.7.4 dependence
ich_3.2.s.7 m3.2.s.7 stability
ich_3.2.p.5.1 m3.2.p.5.1 specification(s)
ich_3.2.s.6 m3.2.s.6 container closure system