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°GCPѧϰ | Ӹְٴٴ鰲ȫ¼ı͹

  • 2020-06-29 14:07
  • ߣ̽
  • Դƽ.15999909920

2020°桶ҩٴ淶GCP޶ҹGCPICHӹҪ֣2020GCPУߡо߼ڵٴίԱְȷ2003GCPȣ2020GCP֮ǰļٴ鰲ȫ¼ı仯Ƚϴҵ顣ߴӸְĽǶٴٴ鰲ȫ¼ı͹


ڰȫ¼ְ


ߵְ°GCPʮȷ߸ҩڼҩƷİȫʮȷӦҪʱޱҩﲻӦ⣬2018꡶ҩٴڼ䰲ȫݿٱ׼ͳ򡷵ڰָҩٴ鰲ȫϢԤزӦ塱


ίԱְ°GCPʮȷίԱְDZߵȨͰȫӦرעߡίԱӦעȷҪо߼ʱ棺пҷԤزӦܶߵİȫٴʵʩӰϢίԱȨֹͣδҪʵʩַ߳Ԥ𺦵ٴ顱


°GCPʮ涨оӦʺϵҽƴٴڼ䣬߳صIJ¼ٴʵ쳣ʱоߺٴӦ֤ߵõƵҽƴʵ֪ߡȷٴо߹ͬеΡٴһְ޶ҩƷע취ʮָҩٴгִΧԤڵزӦ֤֤ٴҩƷʱߺҩٴӦֹͣҩٴ顱ֹͣһٴ飬ҲΪ˱߰ȫ


ٴյ¼;


Ϊٴյ¼Ҫ;


һоߵı档ڳֿӰٴʵʩ߷յоӦߡίԱٴ汨档


ߵı档Ӧñ棺1ɷԤزӦ (Suspected Unexpected Serious Adverse Reaction, SUSARٱвμٴо߼ٴίԱ᣻2ҩзڼ䰲ȫԸ±棬Ӧͨвμٴо߼ίԱ᣻3ٴзֵĿӰ߰ȫӰٴʵʩܸıίԱͬ⣬ʱ֪ͨоߺͻҩƷලš


Ϊ˸õоߺٴְ߱ٴڰȫ¼Ĺ̺͹ҪУҪע¼㣺


1.о߻ҪSAEҩԺǷΪԤ¼


°GCPز¼Serious Adverse Event, SAEıΪ鷽ļоֲᣩй涨SAE⣬оӦ汨SAEյκԴİȫϢ󣬾ӦԡҩԼǷΪԤ¼ȡӦSUSARٱвμٴо߼ίԱ᣻ӦҩƷලźܲűSUSAR


ҵй۵Ϊо߲SAEҩԼǷΪԤ¼Ϊֹ۵㲢ȫ档°GCPֻȷSUSARߣųоߴ߰ȫSAEҩԺǷΪԤ¼о߶ԷSAEߵĴߵĴҪSAEһҲҽѧжϵһ֡


ȫԱָԭGuidance for industry and investigators: Safety reporting requirements for INDs and BA/BE studiesǿƽ,ԣǷвоߡ߶Ҫһ¼ǷΪػво߻֮һĹ۵㣻ԤڣоֲǷΪԤڣо߲ҪԤԣɵIJӦϵо߱ṩϵҲҪǷϱԿԡҩоߵְоǷҪǷΪԤ¼


Ŀǰҹٴ鷢չ⣬ߵзҽѧԱʵϴͬʱΪҩȫڰȫ˵ְûȫλгļҲ𲽵УҩзĻڷչ׶Σвࡣı£һʱڵĹɽ׶Σо߿ԻӦûоֲյϣǷΪԤ¼ٶڲSUSARӦüʱĹעӣһ̶ϿԼSUSAR©


2.ҪֱĺSUSAR(SAE)


ڱSUSAR(SAE)оߺͻԷSAEĸȨͰȫĴԼע̶Dzͬģ˴оߺͻְĽǶȳҪֱSUSAR(SAE)оӦ汨SAEͬʱ齫SUSAR(оΪSUSAR)SAEίԱᣬԲȡĴʩߡDZSUSARSAEձίԱҪ󣬱Ϊʱ޿24Сʱʱ޵Ҫ󡣴ӱ߰ȫĽǶȣ鱾SUSAR(SAE)ڱʱޡʽ鼰ʱԵȷ費ͬǡ


3.оҪ԰ȫϢĶǩպʹо߻ϱίԱᡣ


°GCPڶʮоյṩٴذȫϢӦʱǩĶߵƣǷӦҪʱ߹ͨӦίԱᱨ췽ṩĿҷԤزӦʮᵽӦҷԤزӦٱвμٴо߼ٴίԱ᣻ӦҩƷලźܲűҷԤزӦôӦо߻߱ίԱ᣿ôίԱǷյ2ݱ棬Ĺ


ӸְΪоߺͻǿǶ߰ȫΣоҪ԰ȫϢĶǩպʹҪģҪ߱ϢߵƣǷӦҪʱ߹ͨϱߵȨͰȫΪҩٴ鰲ȫϢSUSAR壬Ӧȷϰ涨ʱйػͲű档δʱòSUSARɱҪҩٴ鷽ֹͣҩٴ顣


Σڱ̺·Ż⣬ΪҪԴĺSUSAR


SUSARоڻ֪24Сʱڱ˱ίԱᣬߵغ޸µϣоǩպ󱨸ίԱᱸɣظ飻оߵжϲһ£ҩжϲһ£ߵоǩպ󱨸ίԱᣬ漰ίԱҪٴߵķա


SUSARǿо߶SUSAR¼֪˱ߵơ˭ίԱᲢҪ߻о߽ίԱᶼû⣬˫浵ίԱǩյļ֤SUSARѾͿԣҪظ档ڰȫԱҲһġ


4.Ҫע߱ϵĽ衣


ΪٴִеλҪվڻǶȣȫֵӽŻ߱ϵͻٴооԱѵҩͬٴŻ顢ѧȷ潨Ƶ߱ϵٴУ߰ȫ


֮°GCPڸλַdzȷߡоߺͻְȷĽ綨ڿȫ¼ĹͱʱӦѭ˼·Ǽͱ壬оߺͻְDZ߰ȫо߸ǿĿ߰ȫߡоߺͻְߣڰȫ¼Ĺؼ⣬˭˭桢ʱ޵ͷdzˡ̽ ׶ҽƴѧҽҽԺ


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