commiss direct ec april lai principl detail guidelin good clinic practic investig medicin product human requir authoris manufactur import product text eea relev commiss european commun regard treati establish european commun regard direct ec european parliament council april approxim law regul administr provis member state relat implement good clinic practic conduct clinic trial medicin product human articl articl articl thereof direct ec requir adopt principl good clinic practic detail guidelin line principl minimum requir authoris manufactur import investig medicin product detail guidelin document relat clinic trial verifi complianc direct ec principl guidelin good clinic practic ensur conduct clinic trial investig medicin product defin articl direct ec found protect human right digniti human manufactur requir appli investig medicin product provid commiss direct ec octob lai principl guidelin good manufactur practic respect medicin product human investig medicin product human titl iv direct ec european parliament council novemb commun code relat medicin product human provis appli authoris manufactur medicin product part requir need applic market authoris articl direct establish requir applic medicin product intend research develop trial lai minim requir applic manag authoris manufactur import investig medicin product grant content authoris order guarante qualiti investig medicin product clinic trial regard protect trial subject ensur unnecessari clinic trial conduct import defin principl detail guidelin good clinic practic whilst allow result trial document phase ensur expert individu involv design initi conduct record clinic trial appli standard good clinic practic principl detail guidelin good clinic practic defin provis function ethic committe establish member state basi common detail guidelin order ensur protect trial subject time allow harmonis applic member state procedur ethic committe secur complianc clinic trial provis good clinic practic inspector ensur practic effect provis essenti provid detail guidelin minimum standard qualif inspector educ train reason detail guidelin inspect procedur cooper agenc follow inspect laid intern confer harmonis ich reach consensu provid harmonis approach good clinic practic consensu paper account agre committe medicin product human chmp european medicin agenc hereinaft quot agenc quot publish agenc sponsor investig particip account scientif guidelin relat qualiti safeti efficaci medicin product human agre chmp publish agenc pharmaceut commun guidelin publish commiss volum rule govern medicin product european commun conduct clinic trial investig medicin product human safeti protect right trial subject ensur detail rule adopt member state pursuant articl direct ec protect abus individu incap give inform consent cover individu temporarili incap give inform consent emerg situat commerci clinic trial conduct research particip pharmaceut industri great benefit patient concern direct ec recognis specif commerci clinic trial trial conduct authoris medicin product patient characterist cover authoris indic requir fulfil authoris medicin product manufactur import concern consider due specif condit commerci trial conduct member state forese specif modal appli trial conduct authoris medicin product patient characterist order compli principl impos direct manufactur import requir authoris document submit archiv trial master file concern condit commerci research conduct public research place research take place make applic detail good clinic practic unnecessari guarante mean member state ensur case provid specif modal object protect right patient particip trial gener correct applic good clinic practic principl achiev commiss prepar draft guidanc respect measur provid direct accord opinion stand committe medicin product human adopt direct chapter subject matter articl direct lai provis appli investig medicin product human principl good clinic practic detail guidelin line principl refer articl direct ec design conduct report clinic trial human subject involv product requir authoris manufactur import product provid articl direct ec detail guidelin provid articl direct ec document relat clinic trial archiv qualif inspector inspect procedur appli principl detail guidelin requir refer paragraph member state account technic implement modal provid detail guidanc publish commiss rule govern medicin product european union appli principl detail guidelin requir refer paragraph commerci clinic trial conduct research particip pharmaceut industri member state introduc specif modal order account specif trial chapter concern member state account special posit trial plan requir manufactur packag process carri medicin product market authoris mean direct ec manufactur import accord direct conduct patient characterist cover indic market authoris label investig medicin product intend trial natur subject simplifi provis laid good manufactur practic guidelin investig medicin product member state inform commiss member state specif modal implement accord paragraph modal publish commiss chapter good clinic practic design conduct record report clinic trial section good clinic practic articl right safeti trial subject prevail interest scienc societi individu involv conduct trial qualifi educ train experi perform task clinic trial scientif sound guid ethic principl aspect procedur secur qualiti aspect trial compli articl clinic clinic inform investig medicin product adequ support propos clinic trial clinic trial conduct accord declar helsinki ethic principl medic research involv human subject adopt gener assembl world medic associ articl protocol refer point articl direct ec provid definit inclus exclus subject particip clinic trial monitor public polici investig sponsor relev guidanc respect commenc conduct clinic trial articl clinic trial inform record handl store accur report interpret verifi confidenti record trial subject remain protect section ethic committe articl ethic committe establish articl direct ec adopt relev rule procedur implement requir set direct articl thereof ethic committe case retain essenti document relat clinic trial refer articl direct ec year complet trial retain document longer period requir applic requir commun inform ethic committe compet author member state ensur effici system section sponsor articl sponsor deleg trial relat function individu compani institut organis case sponsor remain respons ensur conduct trial final data gener trial compli direct ec direct investig sponsor person section investig brochur articl inform investig brochur refer articl direct ec present concis simpl object balanc promot form enabl clinician potenti investig understand make unbias risk benefit assess appropri propos clinic trial subparagraph appli updat investig brochur investig medicin product market authoris summari product characterist investig brochur investig brochur valid updat sponsor year chapter manufactur import authoris articl authoris provid articl direct ec requir total partial manufactur investig medicin product process divid packag present authoris requir product manufactur intend export authoris requir import countri member state authoris provid articl direct ec requir reconstitut prior packag process carri hospit health centr clinic pharmacist person legal authoris member state carri process investig medicin product intend exclus institut articl order obtain authoris applic meet requir applic type medicin product pharmaceut form manufactur import applic relev manufactur import oper applic relev case viral convent agent inactiv manufactur process applic place product manufactur dispos manufactur import suitabl suffici premis technic equip control facil compli requir direct ec manufactur control storag product perman continu dispos servic qualifi person refer articl direct ec purpos point subparagraph quot type medicin product quot includ blood product immunolog product cell therapi product gene therapi product biotechnolog product human anim extract product herbal product homeopath product radiopharmaceut product product chemic activ ingredi applic provid applic documentari evid compli paragraph articl compet author issu authoris verifi accuraci particular provid applic pursuant articl mean inquiri carri agent member state measur ensur procedur grant authoris complet dai dai compet author receiv valid applic compet author member state requir applic inform particular suppli pursuant articl includ inform qualifi person dispos applic accord point articl compet author concern exercis applic time limit laid paragraph suspend addit data requir suppli articl order ensur requir laid articl compli authoris made condit carri oblig impos authoris grant date authoris appli premis applic type medicin product pharmaceut form applic pursuant point articl articl holder authoris compli requir dispos servic staff compli legal requir exist member state concern manufactur control dispos investig authoris medicin product accord legisl member state concern give prior notic compet author make particular suppli pursuant articl inform compet author immedi qualifi person refer articl direct ec replac unexpectedli agent compet author member state concern access premis time enabl qualifi person refer articl direct ec carri duti place dispos facil compli principl guidelin good manufactur practic medicin product laid commun law detail guidelin line principl refer point paragraph publish commiss revis account technic scientif progress articl holder authoris request chang particular refer point articl time procedur relat request exce dai except case period time extend dai articl compet author suspend revok authoris part holder authoris fail time compli relev requir chapter trial master file archiv articl document refer articl direct ec trial master file consist essenti document enabl conduct clinic trial qualiti data produc evalu document show investig sponsor compli principl guidelin good clinic practic applic requir annex direct ec trial master file provid basi audit sponsor independ auditor inspect compet author content essenti document accord specif phase clinic trial commiss publish addit guidanc order content document articl sponsor investig retain essenti document relat clinic trial year complet retain document longer period requir applic requir agreement sponsor investig essenti document archiv ensur readili request compet author medic file trial subject retain accord nation legisl accord maximum period time permit hospit institut privat practic articl transfer ownership data document document owner assum respons data retent archiv accord articl articl sponsor appoint individu organis respons archiv access archiv restrict name individu respons archiv articl media store essenti document document remain complet legibl requir period retent made compet author request alter record traceabl chapter inspector articl inspector appoint member state pursuant articl direct ec made awar maintain confidenti gain access confidenti inform result good clinic practic inspect accord applic commun requir nation law intern agreement member state ensur inspector complet educ univers level equival experi medicin pharmaci pharmacolog toxicolog relev field member state ensur inspector receiv train train assess regularli action maintain improv skill member state ensur inspector knowledg principl process appli develop medicin product clinic research inspector knowledg applic commun nation legisl guidelin applic conduct clinic trial grant market authoris inspector familiar procedur system record clinic data organis regul healthcar system relev member state countri member state maintain date record qualif train experi inspector inspector provid document set standard oper procedur give detail duti respons ongo train requir procedur maintain date inspector provid suitabl mean identif inspector sign statement declar financi link parti inspect statement consider inspector assign specif inspect articl order ensur presenc skill specif inspect member state appoint team inspector expert qualif experi fulfil collect requir conduct inspect chapter inspect procedur articl good clinic practic inspect place occas conduct clinic trial part verif applic market authoris follow grant authoris accord articl direct ec inspect request coordin european medicin agenc scope regul ec european parliament council connect clinic trial relat applic procedur establish regul inspect conduct accord inspect guidanc document develop support mutual recognit inspect find commun improv harmonis inspect guidanc achiev member state collabor commiss agenc joint inspect agre process procedur share experi train articl member state make publicli territori document relat adopt good clinic practic principl establish legal administr framework good clinic practic inspect oper definit power inspector entri clinic trial site access data ensur request inspector compet author member state access clinic trial site data articl member state provid suffici resourc appoint adequ number inspector ensur effect verif complianc good clinic practic articl member state establish relev procedur verif good clinic practic complianc procedur includ modal examin studi manag procedur condit clinic trial plan perform monitor record follow measur articl member state establish relev procedur appoint expert accompani inspector case request inspect assist member state line articl direct ec cooper inspect member state arrang inspect countri articl member state maintain record nation applic intern inspect includ good clinic practic complianc statu follow articl order harmonis conduct inspect compet author member state guidanc document common provis conduct inspect publish commiss consult member state member state ensur nation inspect procedur complianc guidanc document refer paragraph guidanc document refer paragraph updat regularli scientif technic develop articl member state lai rule ensur confidenti respect inspector expert regard person data requir direct ec european parliament council respect inspect report made member state recipi refer articl direct ec accord nation regul member state subject arrang conclud commun countri chapter final provis articl member state bring forc law regul administr provis compli direct januari latest forthwith commun commiss text provis correl tabl provis direct member state adopt provis refer direct accompani refer occas offici public member state determin refer made member state commun commiss text main provis nation law adopt field cover direct articl direct enter forc twentieth dai public offici journal european union articl direct address member state brussel april commiss günter verheugen vice presid oj oj oj direct amend direct ec oj oj oj