Charter (draft v0.2) (1)(a) Name. (1)(a) Prepared By. (1)(b) Purpose. (1)(b) Business Problem. Evolution of Product Information

Transcription

1 Charter (draft v0.2) Subject: OASIS DITA Pharmaceutical Cntent Subcmmittee DRAFT Charter Date: 21-April-2009 Versin: 0.2 (1)(a) Name Full Name: OASIS DITA Pharmaceutical Cntent Subcmmittee Shrt Name: DITA-PC-SC (1)(a) Prepared By James Averback Life Science Integratin Partners Steffen Frederiksen Cntent Technlgies Ole Andersen Cntent Technlgies (1)(b) Purpse This dcument is intended t be a charter regarding the creatin f the DITA Pharmaceutical Cntent Subcmmittee (DITA-PC-SC). After review, the intent is t finalize a frmal charter fr the DITA-PC-SC. (1)(b) Business Prblem Evlutin f Prduct Infrmatin Authrizatin t market a pharmaceutical prduct fr use in humans requires 3 8 years f nnclinical and clinical studies t adequately assess bth safety and effectiveness f the prduct. As a task f each study cnducted dcumentatin is created which may range frm a simple scientific mem fr an early pharmaclgy study t hundreds f dcuments fr a majr phase III clinical study. The study reprt fr sme clinical studies may cntain thusands f pages including data tabulatins, charts and medical images. A dssier submitted t a Regulatry Authrity n applicatin t market a new prduct can easily require authred dcuments assembled frm the thusands f supprting dcuments that have been created during the prduct s develpment ver a 5 10 year perid. The challenge is enrmus t manage this cntinuusly grwing bdy f prduct infrmatin expressed ver time in thusands f dcuments. As new studies are cnducted and prduct knwledge evlves, the cntent f dcuments frm earlier wrk may becme bslete r less relevant. Hence, the bdy f dcumentatin is cntinuusly evlving thrughut the lifecycle f the prduct. In additin t nnclinical and clinical studies, infrmatin related t manufacturing prcesses, frmulatin design and materials f manufacture and packaging fr the pharmaceutical prduct evlve thrughut its lifecycle. Hundreds f additinal dcuments result frm the extensive testing and validatin f pharmaceutical develpment activities which are required t ensure the pharmaceutical prduct s delivery f the active ingredient is bth safe and effective.

2 (1)(c) Scpe The OASIS DITA Pharmaceutical Cntent Subcmmittee (DITA-PC-SC) will define DITA tpics, maps, assciated metadata prperties and terminlgy t streamline design and creatin f the cmplete bdy f pharmaceutical dcumentatin required t present a prduct fr scientific and regulatry purpses thrughut its lifecycle. These cnstructs will include: a pharmaceutical cntent taxnmy f DITA tpics, the metadata and terminlgy t be assciated with each tpic instance a taxnmy f DITA maps all f which are defined t ptimize reuse and re-purpsed cntent Initial bjectives are t define tpics and maps as required t implement: a) ICH CTD (Cmmn Technical Dcument) cntent specificatin b) US IND (Investigatinal New Drug) cntent specificatin c) EU CTA (Clinical Trial Authrizatin) cntent specificatin d) FDA Structured Prduct Labeling cntent specificatin e) EU Prduct Infrmatin Management cntent specificatins. T ptimize the value f DITA it is an bjective t supprt these specializatins with additinal tpics and maps fr facilitating the business prcesses f cntent design, authring, dcument review and submissin assembly. The subcmmittee will als determine the pssible need fr pharmaceutical DITA specializatins as well as define these specializatins and submit them t the main DITA Technical Cmmittee (TC) fr cnsideratin. Specific elements f cntent which may be cnsidered fr analysis are utlined in Appendix 1: Ptential List f Areas fr Evaluatin f Pharmaceutical Specific DITA Cnstructs (1)(d) Deliverables DITA-PC-SC will deliver recmmendatins fr DITA cnstructs n a peridic basis as they cmplete a standard prcess f draft, review, capture f industry feedback and apprval fr release. The schedule fr specific tpics will be determined by DITA-PC-SC participants based n availability f resurces with adequate dmain expertise and capacity t undertake wrk n a defined schedule. A 12 mnth plan f deliverables will be prvided with updates at 6 mnth intervals. Deliverables frm this SC will include: A set f best-practice recmmendatins n hw t implement the DITA standard cntent architecture in each pharmaceutical dmain DITA cnstructs t include: A series f map, tpic, and metadata templates alng with a systematic taxnmy f pharmaceutical cntent A submissin f draft specificatins f required pharmaceutical DITA specializatins t the main DITA TC

3 DITA cnstructs prvided will be rganized int a standard package frmat t include: a) Statement f business need b) Cntent scpe addressed c) Prcess scpe addressed d) Cncept in peratin hw the DITA cnstructs are envisined t be used e) Glssary f terms f) DITA cnstruct specificatin prvided Fr each DITA cnstruct, a specificatin in standard frmat describing the cnstruct at a high level and each element f the cnstruct at a level adequate t enable implementatin. g) DITA cnstruct implementatin infrmatin prvided Fr each DITA cnstruct, if an implementatin has been cmpleted a descriptin will be prvided with cntact infrmatin shuld a viewer wish t gain access t the implementatin. (1)(e) IPR Mde (t be determined) (1)(f) Audience DITA-PC-SC will be f interest t the fllwing cnstituencies in the pharmaceutical industry: a) Scientists and labratry persnnel respnsible fr design and cnduct f nnclinical studies in pharmaclgy, pharmackinetics, pharmacdynamics and txiclgy. b) Physicians and clinical study scientists respnsible fr design f clinical studies and dcumenting these designs in the frm f a study prtcl, data management plan, statistical analysis plan, mnitring plan r a clinical supply plan c) Persnnel respnsible fr writing nnclinical study reprts d) Persnnel respnsible fr medical writing clinical study reprts including medical writers e) Persnnel respnsible fr prgram and prject management and fr prviding status and decisin supprt infrmatin required thrughut the cnduct f a prduct s lifecycle. f) Persnnel respnsible design and assembly f a prduct dssier suitable fr regulatry submissin fr bth pre-market and pst-marketed prducts g) Persnnel respnsible fr prviding prduct safety infrmatin t meet pst-marketed regulatry bligatins fr peridic safety reprting h) Persnnel respnsible fr prviding pst-marketed manufacturing infrmatin including changes being effected and any ther majr changes in the manufacturing prcess i) Persnnel respnsible fr develpment f prduct labeling including the cmpany cre data sheet and target prduct label prfile j) Persnnel respnsible fr DITA technlgy implementatin

4 (1)(g) Language DITA-PC-SC shall cnduct all discussins and prvide dcumentatin in English. (2a) Nn-nrmative Infrmatin - Other Relevant Wrk Other Wrk Relevant t DITA-PC-SC Dcument and Recrds Management SIAC f the Drug Infrmatin Assciatin A grup is wrking t establish a reference mdel fr pharmaceutical cntent under the auspices f the Dcument and Recrds Management SIAC f the Drug Infrmatin Assciatin. The EDM Reference Mdel wrking grup is cmplementary t the prpsed DITA-PC-SC as it defines cntent, metadata and terminlgy while DITA-PC-SC wrks t define DITA cnstructs such as specializatins and DITA maps. It is anticipated DITA-PC-SC will wrk cllabratively with the DIA EDM Reference Mdel wrking grup (DIA-EDM-RM) t include: a) DITA-PC-SC t request DIA-EDM-RM assessment f prpsed DITA cnstructs b) DITA-PC-SC t request DIA-EDM-RM participatin in jint sessin t assess business need, requirements and apprach fr DITA cnstruct definitin in specific business prcesses related t but nt limited by: ptimized granularity f tpic based cntent fr nnclinical infrmatin ptimized granularity f tpic based cntent fr clinical infrmatin ptimized granularity f tpic based cntent fr chemistry, manufacturing and cntrl infrmatin Medical Writing SIAC f the Drug Infrmatin Assciatin The Medical Writing SIAC is wrking t establish best practices in medical writing under the auspices f Drug Infrmatin Assciatin. The Medical Writing SIAC is cmplementary t the prpsed DITA-PC-SC as it defines authring practices and style f writing fr medical writers in the pharmaceutical industry. DITA-PC-SC will wrk with the Medical Writing SIAC t design DITA maps and relatinships applying standards fr medical writing style and autmatin t crss-reference implementatin in written materials. h) DITA-PC-SC t request Medical Writing SIAC participatin in jint sessin t assess business need, requirements and apprach fr DITA cnstruct definitin in specific business prcesses related t but nt limited by: ptimized granularity f tpic based cntent fr nnclinical infrmatin ptimized granularity f tpic based cntent fr clinical infrmatin ptimized granularity f tpic based cntent fr chemistry, manufacturing and cntrl infrmatin standard crss-reference implementatin fr nnclinical infrmatin standard crss-reference implementatin fr clinical infrmatin standard crss-reference implementatin fr chemistry, manufacturing and cntrl infrmatin HL7 Regulated Prduct Submissin Technical Grup

5 (t be prvided) Structured Prduct Labeling (t be prvided) Prduct Infrmatin Management (t be prvided) (2b) Initial Meetings Initial meeting f a cre planning grup is scheduled fr May 2009 A kickff meeting fr general participants is scheduled fr June 2009 Meetings will generally be cnducted via cnference call with presentatins being distributed in advance. A telephne bridge fr the meeting will be prvided by (meeting spnsr t be determined) (2c) Meeting Schedule At least ne face t face meeting will be cnducted n an annual basis. Spnsrship fr the annual meeting will be sught frm supprting cntributrs. Peridic meetings via cnference call with all participants invited will be nce every 4 weeks. These meetings will require a cnference bridge (spnsr t be determined) (2d) Participant List A cre grup f participants will be assembled frm the fllwing list TBD Additinal participating members will be engaged as the plan fr tpics is defined and will be based n dmain expertise (2e) Cnvener and Technical Cmmittee Rles The DITA-PC-SC cnvener will be Steffen Frederiksen, Cntent Technlgies. Rles in the DITA-PC-SC are: TBD

6 Meeting minutes will be taken by vlunteers n a rtating basis fr the full TC and the tpic r prcess based subcmmittees. (2f) Member Sectin (2)(f) The name f the Member Sectin with which the SC intends t affiliate, if any. (t be determined) (2g) Cntributins f Existing Wrk (2)(g) Optinally, a list f cntributins f existing technical wrk that the prpsers anticipate will be made t this TC. The EDM Reference Mdel published by the EDM Reference Mdel wrking grup f the Dcument and Recrds Management SIAC f the Drug Infrmatin Assciatin. (2h) Frequently Asked Questins (2)(h) Optinally, a draft Frequently Asked Questins (FAQ) dcument regarding the planned scpe f the TC, fr psting n the TC's website. (2i) Wrking Title and Acrnym Cnventin fr Specificatins (2)(i) Optinally, a prpsed wrking title and acrnym fr the specificatin(s) t be develped by the TC.

7 Appendix 1: Ptential List f Areas fr Evaluatin f Pharmaceutical Specific DITA Cnstructs Prcess Platfrm: Clinical Studies Structural elements f clinical study design including thse addressing: inclusin/exclusin criteria subject/patient ppulatin and demgraphics including screening study scientific design and cntrls study regulatry design study regulatry design fr cnsideratin f ethics including statements required by external and internal ethics review bdies and patient cnsent study drug frmulatin including dsage strength, dsage frm and investigatinal labeling study drug supply plan and distributin prcedures including regulatry waivers required fr distributin f investigatinal medicinal prducts study risk management apprach, methds and safety review bdies study site mnitring standards and prcedures study data management methds and prcedures study data analysis methds and prcedures fr efficacy study data analysis methds and prcedures fr safety NOTE: Suggested belw are cnsideratins fr bth regulatry and. The differences are intended nly t be with respect t frmat, degree f detail and specific cntent requirements which may differ fr a spnsr cmpany as ppsed t a Regulatry Authrity. Structural elements f clinical study reprting tabular data presentatins fr line listings f safety infrmatin tabular data presentatins fr line listings f efficacy infrmatin tabular data presentatins fr summarized safety infrmatin tabular data presentatins fr summarized efficacy infrmatin graphical data presentatins fr safety infrmatin graphical data presentatins fr efficacy infrmatin cntent fr a simple scientific study synpsis element cntent fr a cmplex scientific study synpsis element cntent fr a simple regulatry study synpsis element cntent fr a cmplex regulatry study synpsis element cntent fr a study statement f ethics general and special cnsideratins cntent fr a study statement f patient cnsent general and special cnsideratins cntent fr a study statement f intrductin fr regulatry cntent fr a study statement f intrductin fr cntent fr a study statement f bjectives fr regulatry cntent fr a study statement f bjectives fr cntent fr a study statement f investigatinal plan verview fr regulatry cntent fr a study statement f investigatinal plan verview fr cntent fr a study statement f investigatinal plan time and events schedule fr regulatry cntent fr a study statement f investigatinal plan time and events schedule fr

8 cntent fr a study statement f investigatinal plan subject/patient screening fr regulatry cntent fr a study statement f investigatinal plan subject/patient screening fr cntent fr a study statement f investigatinal plan dsing regimen fr regulatry cntent fr a study statement f investigatinal plan dsing regimen fr scientific cntent fr a study statement f investigatinal plan subject/patient pre-treatment fr regulatry cntent fr a study statement f investigatinal plan subject/patient pre-treatment fr cntent fr a study statement f investigatinal plan subject/patient pst-treatment fr regulatry cntent fr a study statement f investigatinal plan subject/patient pst-treatment fr cntent fr a study statement f dispsitin f subject/patient ppulatin fr regulatry cntent fr a study statement f reasn fr discntinuatin f subject/patient ppulatin fr regulatry cntent fr a study statement f reasn fr exclusin f subject/patient data fr regulatry cntent fr a study statement f subject/patient demgraphics fr regulatry cntent fr a study statement f measurements f subject/patient treatment cmpliance fr regulatry cntent fr a study statement f efficacy results fr the primary endpint fr regulatry cntent fr a study statement f efficacy results fr the primary endpint fr scientific cntent fr a study statement f efficacy results fr the secndary endpint(s) fr regulatry cntent fr a study statement f efficacy results fr the secndary endpint(s) fr cntent fr a study statement f verview f safety results fr regulatry cntent fr a study statement f verview f safety results fr cntent fr a study statement f safety results fr adverse events related t study drug fr regulatry cntent fr a study statement f safety results fr adverse events related t study drug fr cntent fr a study statement f safety results fr adverse events leading t discntinuatin fr regulatry cntent fr a study statement f safety results fr adverse events leading t discntinuatin fr cntent fr a study statement f safety results fr adverse events leading t death fr regulatry cntent fr a study statement f safety results fr adverse events leading t death fr cntent fr a study statement f discussin f data findings fr regulatry cntent fr a study statement f discussin f data findings fr

9 cntent fr a study statement f cnclusins frm data fr regulatry cntent fr a study statement f cnclusins frm data fr Prcess Platfrm: Preclinical Studies Structural elements f nnclinical study design including thse addressing: assay design including reprting f validatin studies study scientific design and cntrls study regulatry design including that required fr cmpliance with Gd Labratry Practice study regulatry design fr cnsideratin f ethics in using animal mdels fr testing study drug frmulatin including dsage strength and dsage frm study media reference standards study data management methds and prcedures study data analysis methds and prcedures fr efficacy study data analysis methds and prcedures fr txicity study data analysis methds and prcedures fr pharmackinetics study data analysis methds and prcedures fr pharmacdynamics Structural elements f nnclinical study reprting tabular data presentatins fr pharmackinetics infrmatin tabular data presentatins fr pharmacdynamics infrmatin tabular data presentatins fr txiclgy infrmatin tabular data presentatins fr summarized safety infrmatin tabular data presentatins fr summarized efficacy infrmatin tabular data presentatins fr submissin presentatins cntent fr a study statement f study drug frmulatin including dsage strength and dsage frm cntent fr a study statement f animal care cntent fr a study statement f animal mdel grup cmpsitin cntent fr a study statement f animal dsing ratinale cntent fr a study statement f experimental prcedure cntent fr a study statement f analysis prcedure cntent fr a study statement f discussin f data findings fr regulatry cntent fr a study statement f discussin f data findings fr Prcess Platfrm: Chemistry, Manufacturing and Cntrls Infrmatin (t be prvided) Prcess Platfrm: Medical Cmmunicatins and Educatin (t be prvided)