涓�銆佸悕璇嶈В閲婏細
1.
涓村簥璇曢獙
(
Clinical
Trial):
鎸囦换浣曞湪浜轰綋
(
鐥呬汉鎴栧仴搴峰織鎰胯�?/p>
)
杩涜鑽墿鐨勭郴缁熸�х爺绌讹紝
浠ヨ瘉瀹炴垨鎻ず璇曢獙鑽墿鐨勪綔鐢ㄣ�佷笉鑹弽搴斿強
/
鎴栬瘯楠岃嵂鐗╃殑鍚告敹銆佸垎甯冦�佷唬璋㈠拰鎺掓硠锛岀洰鐨?/p>
鏄‘瀹氳瘯楠岃嵂鐗╃殑鐤楁晥涓庡畨鍏ㄦ�с�?/p>
2. GCP(Good Clinical Practice):
鑽墿涓村簥璇曢獙璐ㄩ噺绠＄悊瑙勮寖銆?/p>
3.
璇曢獙鏂规
(Protocol):
鍙欒堪璇曢獙鐨勮儗鏅�佺悊璁哄熀纭�鍜岀洰鐨勶紝浠ュ強璇曢獙璁捐銆佹柟娉曞拰缁?/p>
缁囷紝鍖呮嫭缁熻瀛﹁�冭檻銆佽瘯楠屾墽琛屽拰瀹屾垚鐨勬潯浠躲�傛柟妗堝繀椤荤敱鍙傚姞璇曢獙鐨勪富瑕佺爺绌惰�呫�佺爺绌?/p>
鏈烘瀯鍜岀敵鍔炶�呯绔犲苟娉ㄦ槑鏃ユ湡銆傝瘯楠屾柟妗堟姤浼︾悊濮斿憳浼氬鎵瑰悓鎰忓悗鏂瑰彲瀹炴柦銆?/p>
4.
鐮旂┒鑰呮墜鍐?/p>
(Investigator
鈥?/p>
s
Brochure):
鏄湁鍏宠瘯楠岃嵂鐗╁湪杩涜浜轰綋鐮旂┒鏃跺凡鏈夌殑
涓村簥涓庨潪涓村簥璧勬枡銆?/p>
5.
鐮旂┒鑰?/p>
(Investigator):
瀹炴柦涓村簥璇曢獙骞跺涓村簥璇曢獙鐨勮川閲忓強鍙楄瘯鑰呭畨鍏ㄥ拰鏉冪泭鐨勮礋
璐ｈ�呫�傜爺绌惰�呭繀椤荤粡杩囪祫鏍煎鏌ワ紝鍏锋湁涓村簥璇曢獙鐨勪笓涓氱壒闀裤�佽祫鏍煎拰鑳藉姏銆?/p>
6.
鍗忚皟鐮旂┒鑰?/p>
(Coordinating
Investigator):
鍦ㄥ涓績涓村簥璇曢獙涓礋璐ｅ崗璋冨弬鍔犲悇涓?/p>
蹇冪爺绌惰�呭伐浣滅殑涓�鍚嶇爺绌惰�呫�?/p>
7.
鐩戞煡鍛?/p>
(Monitor):
鐢辩敵鍔炶�呬换鍛藉苟瀵圭敵鍔炶�呰礋璐ｇ殑鍏锋湁鐩稿叧鐭ヨ瘑鐨勪汉鍛橈紝鍏朵换鍔℃槸
鐩戞煡鍜屾姤鍛婅瘯楠岀殑杩涜鎯呭喌鍜屾牳瀹炴暟鎹�?/p>
8.
绋芥煡
(Audit)
锛?/p>
鎸囩敱涓嶇洿鎺ユ秹鍙婅瘯楠岀殑浜哄憳鎵�杩涜鐨勪竴绉嶇郴缁熸�ф鏌ワ紝
浠ュ垽瀹氳瘯楠岀殑
瀹炴柦锛屾暟鎹殑璁板綍鍜屽垎鏋愭槸鍚︿笌璇曢獙鏂规銆佹爣鍑嗘搷浣滆绋嬩互鍙婅嵂鐗╀复搴婅瘯楠岀浉鍏虫硶瑙勮姹?