中国临床试验注册中心 - 世界卫生组织国际临床试验注册平台一级注册机构

注册号： Registration number：	ChiCTR2500113001
最近更新日期： Date of Last Refreshed on：	2025-11-24 01:31:26
注册时间： Date of Registration：	2025-11-24 00:00:00
注册号状态：	补注册
Registration Status：	Retrospective registration
注册题目：	一项评价银杏去甲基酮酯清淤片治疗湿性年龄相关性黄斑变性患者的有效性和安全性——随机、双盲、安慰剂对照的临床研究
Public title：	A randomized, double-blind, placebo-controlled clinical study evaluating the efficacy and safety of ginkgo biloba demethylketone ester silting tablets in patients with wet age-related macular degeneration
注册题目简写：
English Acronym：
研究课题的正式科学名称：	一项评价银杏去甲基酮酯清淤片治疗湿性年龄相关性黄斑变性患者的有效性和安全性——随机、双盲、安慰剂对照的临床研究
Scientific title：	A randomized, double-blind, placebo-controlled clinical study evaluating the efficacy and safety of ginkgo biloba demethylketone ester silting tablets in patients with wet age-related macular degeneration
研究课题代号(代码)： Study subject ID：
在二级注册机构或其它机构的注册号： The registration number of the Partner Registry or other register：

申请注册联系人：	李善学	研究负责人：	王莉菲
Applicant：	Li Shanxue	Study leader：	Wang Lifei
申请注册联系人电话： Applicant telephone：	+86 319 323 7196	研究负责人电话： Study leader's telephone：	+86 319 323 7196
申请注册联系人传真： Applicant Fax：		研究负责人传真： Study leader's fax：
申请注册联系人电子邮件： Applicant E-mail：	956537877@qq.com	研究负责人电子邮件： Study leader's E-mail：	wlfhb@126.com
申请单位网址(自愿提供)： Applicant website(voluntary supply)：		研究负责人网址(自愿提供)： Study leader's website(voluntary supply)：
申请注册联系人通讯地址：	河北省邢台市泉北东大街399号	研究负责人通讯地址：	河北省邢台市泉北东大街399号
Applicant address：	No. 399, Quanbei East Street, Xingtai City, Hebei Province	Study leader's address：	No. 399, Quanbei East Street, Xingtai City, Hebei Province
申请注册联系人邮政编码： Applicant postcode：		研究负责人邮政编码： Study leader's postcode：
申请人所在单位：	河北省眼科医院
Applicant's institution：	Hebei Eye Hospital
研究负责人所在单位：	河北省眼科医院
Affiliation of the Leader：	Hebei Eye Hospital

是否获伦理委员会批准：	是
Approved by ethic committee：	Yes
伦理委员会批件文号： Approved No. of ethic committee：	YK-ZJ202400102	伦理委员会批件附件： Approved file of Ethical Committee：	查看附件View
批准本研究的伦理委员会名称：	河北省眼科医院临床试验伦理委员会
Name of the ethic committee：	Hebei Eye Hospital clinical Trial Ethics Committee
伦理委员会批准日期： Date of approved by ethic committee：	2024-11-22 00:00:00
伦理委员会联系人：	张晓
Contact Name of the ethic committee：	Zhang Xiao
伦理委员会联系地址：	河北省邢台市泉北东大街399号
Contact Address of the ethic committee：	No. 399, Quanbei East Street, Xingtai City, Hebei Province
伦理委员会联系人电话： Contact phone of the ethic committee：	+86 319 3237720	伦理委员会联系人邮箱： Contact email of the ethic committee：	hbsykyyll@126.com

研究实施负责（组长）单位：

河北省眼科医院

Primary sponsor：

Hebei Eye Hospital

研究实施负责（组长）单位地址：

河北省邢台市泉北东大街399号

Primary sponsor's address：

No. 399, Quanbei East Street, Xingtai City, Hebei Province

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：	中国	省(直辖市)：	河北省	市(区县)：
Country：	China	Province：	Hebei	City：
单位(医院)：	河北省眼科医院	具体地址：	河北省邢台市泉北东大街399号
Institution hospital：	Hebei Eye Hospital	Address：	No. 399, Quanbei East Street, Xingtai City, Hebei Province

经费或物资来源：

自选课题（自筹）

Source(s) of funding：

Self-selected topic (self-funded)

研究疾病：

湿性年龄相关性黄斑变性（wAMD）

Target disease：

Wet age-related macular degeneration (wAMD)

研究疾病代码：

Target disease code：

研究类型：

干预性研究

Study type：

Interventional study

研究所处阶段：

其它

Study phase：

N/A

研究设计：

随机平行对照

Study design：

Parallel

研究目的：

主要目的：在湿性年龄相关性黄斑变性（wAMD）患者中，评价服用银杏去甲基酮酯清淤片的有效性。次要目的：在wAMD患者中，评价银杏去甲基酮酯清淤片临床安全性。

Objectives of Study：

Main Objectives: To evaluate the effectiveness of ginkgo demethylketone ester desilting tablets in patients with wet age-related macular degeneration (wAMD). Secondary Objectives: To evaluate the clinical safety of ginkgo biloba demethylketone ester desilting tablets in patients with wAMD.

药物成份或治疗方案详述：

Description for medicine or protocol of treatment in detail：

纳入标准：

Inclusion criteria

排除标准：

1.研究眼存在视网膜下或视网膜内出血且出血面积>=病灶总面积的50%，或出血位于中心凹下且面积>=1个视盘面积（DA）； 2.研究眼存在累及中心凹的瘢痕、纤维化、萎缩或密集中心凹下硬性渗出； 3.研究眼存在非wAMD导致的CNV（如外伤、病理性近视、多灶性脉络膜炎、眼组织胞浆菌病、血管样条纹）； 4.研究眼存在除wAMD以外的可能影响中心视力和/或黄斑检测的任何眼部疾病或病史（糖尿病视网膜病变、视网膜静脉阻塞、视网膜脱离、黄斑裂孔、黄斑前膜、累及黄斑的视网膜色素上皮撕裂、玻璃体黄斑牵引综合症、视神经疾病等）； 5.研究眼首次给药前90天内曾行内眼手术（如白内障摘除、玻璃体切除、黄斑区激光光凝治疗等）或30天内曾行外眼手术； 6.研究眼存在角膜移植病史或角膜营养不良； 7.研究眼首次给药前30天内曾有玻璃体出血； 8.研究眼首次给药前90天内曾眼内或全身给药使用过皮质类固醇或30天内曾球周给药使用过皮质类固醇； 9.研究眼存在控制不佳的青光眼（定义为经抗青光眼治疗后眼内压仍>=21mmHg），和/或曾接受过青光眼滤过性手术（如小梁切除术、巩膜咬切术、非穿透性小梁手术等）； 10.研究眼无晶状体（人工晶体眼除外）或晶状体后囊膜破裂（距首次给药前30天以上的人工晶体植入后的钇-铝-石榴石（YAG）激光后囊切开术除外）； 11.研究眼存在的眼内状况，可能需要在研究期间进行禁用药物或手术干预的； 12.研究眼存在影响眼底检查或OCT成像的屈光间质浑浊和/或瞳孔缩小； 13.研究眼任何可能的屈光矫正或白内障手术之前的等效球面屈光度>=-8D； 14.研究眼存在巩膜软化症； 15.任意眼曾接除激光光凝术以外的手术治疗（如光动力学治疗（PDT）、外放射、经瞳孔温热疗法及其他黄斑下手术等）； 16.任意眼存在葡萄膜炎病史； 17.任意眼存在眼内、眼外或眼周活动性炎症或感染； 18.独眼患者； 19.已知对荧光素、聚维酮碘或吲哚菁绿或研究药物活性成分及其辅料过敏； 20.首次给药前180天内发生过心肌梗塞和/或脑梗塞； 21.患有全身免疫性疾病； 22.目前存在需要全身治疗的严重感染性疾病； 23.合并有不能控制的高血压（定义为经抗高血压药物治疗后，坐位收缩压>=160mmHg 或舒张压>=95mmHg）； 24.患有甲状腺功能障碍性疾病者； 25.肝功能损伤，定义为ALT和AST升高超过正常上限（ULN）的1.5倍； 26.胆红素水平超过正常上限（ULN）的1.5倍； 27.未进行抗凝治疗，国际标准化比值（INR）>=1.3，或凝血功能受损的其他证据； 28.肾功能不全，估算的肾小球滤过率（eGRF）<60 mL/min/1.73 m^2； 29.空腹状态下，甘油三酯（TG）>=2.26mmol/L（200mg/dL）和低密度脂蛋白（LDL-C）>=4.14mmol/L（160mg/dL）者； 30.B超检查为中重度脂肪肝者； 31.存在无法控制的临床问题（如严重的精神、神经、心血管、呼吸、泌尿等系统疾病以及恶性肿瘤等）； 32.有以下实验室检查异常者：乙型肝炎患者【乙肝表面抗原（HBsAg）阳性，乙肝病毒脱氧核糖核酸（HBV-DNA）低于检测下限允许入组】；丙型肝炎患者【若丙肝病毒（HCV）抗体阳性，丙肝病毒核糖核酸（HCV-RNA）低于检测下限允许入组】；梅毒筛查【梅毒螺旋体抗体（Tp-Ab）】阳性；已知人类免疫缺陷病毒（HIV）阳性病史或HIV筛查阳性； 33.妊娠期、哺乳期女性，或研究期间及末次给药结束90天内不愿采取充分避孕措施且有生育能力男性或女性患者； 34.首次给药前90天内参加过任何药物（维生素和矿物质除外）或器械临床试验且已使用试验药物或已接受器械治疗； 35.研究者认为不适合入选本研究的其他情况。

Exclusion criteria：

1. The study eye has subretinal or intraretinal hemorrhage with the hemorrhage area >=50% of the total lesion area, or the hemorrhage is located under the fovea centralis and the area is >=1 optic disc area (DA); 2. The study eye has scars, fibrosis, atrophy involving the fovea centralis or dense hard exudation under the fovea centralis; 3. Study the presence of CNV in the eyes that is not caused by wAMD (such as trauma, pathological myopia, multifocal choroiditis, histoplasmosis of the eye, and vascular streaks); 4. The study eye has any ocular diseases or medical history other than wAMD that may affect central vision and/or macular detection (diabetic retinopathy, retinal vein occlusion, retinal detachment, macular hole, epiretinal membrane, retinal pigment epithelium tear involving the macula, vitreous macular traction syndrome, optic nerve diseases, etc.); 5. The study eye had undergone internal eye surgery (such as cataract extraction, vitrectomy, macular laser photocoagulation therapy, etc.) within 90 days before the first administration or external eye surgery within 30 days. 6. The study eye has a history of corneal transplantation or corneal dystrophy; 7. There was vitreous hemorrhage in the study eye within 30 days before the first administration; 8. The study eye had received intraocular or systemic administration of corticosteroids within 90 days before the first administration, or had received peribulbar administration of corticosteroids within 30 days before the first administration. 9. The study eye has poorly controlled glaucoma (defined as intraocular pressure remaining >=21mmHg after anti-glaucoma treatment), and/or has undergone glaucoma filtering surgery (such as trabeculectomy, sclerectomy, non-penetrating trabeculectomy, etc.); 10. The study eye has no lens (except for intraocular lens eyes) or posterior capsule rupture of the lens (except for yttrium-aluminum-garnet (YAG) laser posterior capsule incision after intraocular lens implantation more than 30 days before the first administration); 11. Where the intraocular conditions of the eye under study may require the use of prohibited drugs or surgical intervention during the study period; 12. The study eye has refractive media opacity and/or pupil constriction that affect fundus examination or OCT imaging; 13. The equivalent spherical refractive power of the study eye before any possible refractive correction or cataract surgery is greater than or equal to -8D; 14. The studied eye has scleral softening syndrome; 15. Either eye has undergone surgical treatment other than laser photocoagulation (such as photodynamic therapy (PDT), external radiation, transpupillary thermotherapy, and other submacular surgeries, etc.); 16. There is a history of uveitis in either eye; 17. There is active inflammation or infection within, outside or around the eye in either eye; 18. One-eyed patients; 19. Known to be allergic to fluorescein, povidone iodine or indocyanine green or the active ingredient of the investigational drug and its excipients; 20. Myocardial infarction and/or cerebral infarction occurred within 180 days prior to the first administration; 21. Suffering from systemic immune diseases; 22. At present, there are serious infectious diseases that require systemic treatment; 23. There is uncontrollable hypertension (defined as a sitting systolic blood pressure of >=160mmHg or a diastolic blood pressure of >=95mmHg after antihypertensive drug treatment); 24. People with thyroid dysfunction diseases; 25. Liver function impairment is defined as elevated ALT and AST levels exceeding 1.5 times the upper limit of normal (ULN); 26. The bilirubin level exceeds 1.5 times the upper limit of normal (ULN). 27. No anticoagulant therapy was received, with an international normalized ratio (INR) >=1.3, or other evidence of impaired coagulation function; 28. Renal insufficiency, estimated glomerular filtration rate (eGRF) <60 mL/min/1.73 m^2; 29. In the fasting state, those with triglyceride (TG) >=2.26mmol/L (200mg/dL) and low-density lipoprotein (LDL-C) >=4.14mmol/L (160mg/dL); 30. Those diagnosed with moderate to severe fatty liver by B-ultrasound examination; 31. There are uncontrollable clinical problems (such as severe mental, neurological, cardiovascular, respiratory, urinary and other system diseases as well as malignant tumors, etc.); 32. Those with the following abnormal laboratory tests: Hepatitis B patients [positive hepatitis B surface antigen (HBsAg), hepatitis B virus deoxyribonucleic acid (HBV-DNA) below the detection limit are allowed to be enrolled]; Patients with hepatitis C [If hepatitis C virus (HCV) antibody is positive and hepatitis C virus ribonucleic acid (HCV-RNA) is below the detection limit, they are allowed to be enrolled]; The syphilis screening was positive for Treponema pallidum antibody (Tp-Ab). Known history of positive human immunodeficiency virus (HIV) or positive HIV screening; 33. Pregnant or lactating women, or fertile male or female patients who were unwilling to take adequate contraceptive measures during the study period and within 90 days after the last administration; 34. Have participated in any clinical trials of drugs (excluding vitamins and minerals) or devices within 90 days prior to the first administration and have used the investigational drugs or received device treatment; 35. Other circumstances that the researchers consider unsuitable for inclusion in this study.

研究实施时间：

Study execute time：

从 From 2024-11-01 00:00:00至 To 2027-12-31 00:00:00

征募观察对象时间：

Recruiting time：

从 From 2025-02-12 00:00:00 至 To 2026-12-31 00:00:00

干预措施：

Interventions：

组别：	试验组	样本量：	72
Group：	Experimental group	Sample size：	72
干预措施：	银杏去甲基酮酯清淤片，4片/次，口服，每日2次，连续给药12周。	干预措施代码：
Intervention：	Ginkgo biloba demethylketone ester desilting tablet, 4 tablets/time, orally, twice a day, for 12 weeks.	Intervention code：

组别：	对照组	样本量：	72
Group：	Control group	Sample size：	72
干预措施：	银杏去甲基酮酯清淤片模拟剂，4片/次，口服，每日2次，连续给药12周。	干预措施代码：
Intervention：	Ginkgo biloba demethylketone desilting tablet simulator, 4 tablets/time, orally, twice a day for 12 weeks.	Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：	中国	省(直辖市)：	河北省	市(区县)：
Country：	China	Province：	Hebei	City：
单位(医院)：	河北省眼科医院	单位级别：	三级甲等
Institution hospital：	Hebei Eye Hospital	Level of the institution：	Tertiary A

测量指标：

Outcomes：

指标中文名：	12周内两组接受抗VEGF再注射的受试者比例。	指标类型：	主要指标
Outcome：	Proportion of subjects receiving anti-VEGF reinjection in both groups within 12 weeks.	Type：	Primary indicator
测量时间点：	12周内	测量方法：	接受抗VEGF补救治疗标准：nAMD疾病符合以下活跃体征之一的受试者给与抗VEGF治疗：①BCVA较之前最高值下降≥5个字母；②出现新的视网膜出血；③OCT显示存在视网膜内或视网膜下积液，且CRT较本研究最低值增加≧50μm。统计接受补救治疗的受试者比例。
Measure time point of outcome：	Within 12 weeks	Measure method：	Criteria for receiving anti-VEGF remedial therapy: Subjects with nAMD disease meeting one of the following active signs were given anti-VEGF therapy: ①BCVA decreased by ≥5 letters from the previous maximum; ② New retinal hemorrhage occurs; (3) OCT showed intraretinal or subretinal fluid accumulation, and CRT increased by ≧50μm from the lowest value in this study. The proportion of subjects receiving remedial treatment was measured.

指标中文名：	12周内两组接受抗VEGF的平均再注射次数；	指标类型：	次要指标
Outcome：	The mean number of reinjections of anti-VEGF in the two groups within 12 weeks;	Type：	Secondary indicator
测量时间点：	12周内	测量方法：	接受抗VEGF补救治疗标准：nAMD疾病符合以下活跃体征之一的受试者给与抗VEGF治疗：①BCVA较之前最高值下降≥5个字母；②出现新的视网膜出血；③OCT显示存在视网膜内或视网膜下积液，且CRT较本研究最低值增加≧50μm。统计接受补救治疗的平均再注射次数。
Measure time point of outcome：	Within 12 weeks	Measure method：	Criteria for receiving anti-VEGF remedial therapy: Subjects with nAMD disease meeting one of the following active signs were given anti-VEGF therapy: ①BCVA decreased by ≥5 letters from the previous maximum; ② New retinal hemorrhage occurs; (3) OCT showed intraretinal or subretinal fluid accumulation, and CRT increased by ≧50μm from the lowest value in this study. The average number of reinjections received for remedial treatment was measured.

指标中文名：	根据ETDRS视力表评估，研究过程中第4周末、第8周末、第12周末最佳矫正视力（BCVA）较基线改善的字母数；	指标类型：	次要指标
Outcome：	The number of letters of best corrected visual acuity (BCVA) improvement from baseline at week 4, week 8, and week 12 during the study, as assessed by the ETDRS eye chart;	Type：	Secondary indicator
测量时间点：	第4周末、第8周末、第12周末	测量方法：	检查受试者第4周末、第8周末、第12周末最佳矫正视力（BCVA）较基线改善的字母数。
Measure time point of outcome：	Weekends 4, 8, 12	Measure method：	The number of letters of improvement from baseline in best corrected visual acuity (BCVA) at week 4, week 8, and week 12 were examined.

指标中文名：	根据ETDRS视力表评估，第4周末、第8周末、第12周末BCVA较基线提高≥5、≥10、≥15个字母的受试者比例；	指标类型：	次要指标
Outcome：	The proportion of subjects with BCVA improvement of ≥5, ≥10, ≥15 letters from baseline at week 4, week 8, and week 12, as assessed by ETDRS visual acuity chart;	Type：	Secondary indicator
测量时间点：	第4周末、第8周末、第12周末	测量方法：	第4周末、第8周末、第12周末对受试者再次进行BCVA检查，统计较基线提高≥5、≥10、≥15个字母的受试者比例；
Measure time point of outcome：	Weekends 4, 8, 12	Measure method：	BCVA examination was performed again at the end of the 4th, 8th and 12th week to statistically increase the proportion of subjects with ≥5, ≥10 and ≥15 letters compared with baseline.

指标中文名：	根据光学相干断层扫描（OCT）评估，第4周末、第8周末、第12周末中央视网膜厚度（CRT）相对于基线的变化；	指标类型：	次要指标
Outcome：	Changes in central retinal thickness (CRT) relative to baseline as assessed by optical coherence tomography (OCT) at weekend 4, 8, and 12;	Type：	Secondary indicator
测量时间点：	第4周末、第8周末、第12周末	测量方法：	根据第4周末、第8周末、第12周末光学相干断层扫描（OCT）检查，评估受试者第4周末、第8周末、第12周末中央视网膜厚度（CRT）相对于基线的变化。
Measure time point of outcome：	Weekends 4, 8, 12	Measure method：	Changes in central retinal thickness (CRT) relative to baseline were assessed at weekend 4, 8, and 12 based on optical coherence tomography (OCT) at weekend 4, 8, and 12.

指标中文名：	根据FA评估，第12周末脉络膜新生血管（CNV）渗漏面积相对于基线的变化。	指标类型：	次要指标
Outcome：	Changes in the area of choroidal neovascularization (CNV) leakage relative to baseline at the end of week 12, as assessed by FA.	Type：	Secondary indicator
测量时间点：	第12周末	测量方法：	根据第12周末FA检查，评估受试者第12周末脉络膜新生血管（CNV）渗漏面积相对于基线的变化。
Measure time point of outcome：	Weekend 12	Measure method：	Changes in the area of choroidal neovascularization (CNV) leakage relative to baseline at the end of week 12 were assessed based on the end 12 FA examination.

指标中文名：	全身安全性	指标类型：	次要指标
Outcome：	Whole body safety	Type：	Secondary indicator
测量时间点：	筛选期及治疗期第12周末/筛选期及治疗期第1周、第4周末、第8周末、第12周末	测量方法：	筛选期及治疗期第12周末进行全身症状和体征、临床实验室检查（血常规、血生化、血脂生化、甲状腺功能、尿常规）、凝血功能、体格检查、心电图；筛选期及治疗期第1周、第4周末、第8周末、第12周末进行生命体征检测。
Measure time point of outcome：	Screening period and treatment period The 12th weekend/Screening period and treatment period the 1st	Measure method：	Systemic symptoms and signs, clinical laboratory tests (blood routine, blood biochemistry, lipid biochemistry, thyroid function, urine routine), coagulation function, physical examination, electrocardiogram were performed at the end of the screening period and the 12th week of treatment period. Vital signs were detected at the 1st, 4th, 8th, and 12th week of screening and treatment.

指标中文名：	眼部安全性	指标类型：	次要指标
Outcome：	Eye safety	Type：	Secondary indicator
测量时间点：	筛选期及治疗期第1周、第4周末、第8周末、第12周末	测量方法：	筛选期及治疗期第4周末、第8周末、第12周末进行眼部的症状和体征、眼科检查（眼底检查、眼内压等）评估眼部安全性，从OCT、眼底照相（CFP）和荧光素血管造影（FA）获得的影像学资料也可用于眼部安全性评估；治疗期第1周检测视力及眼内压。
Measure time point of outcome：	Screening period and treatment period: Week 1, weekend 4, weekend 8, weekend 12	Measure method：	During the screening period and treatment period, ocular signs and symptoms, ophthalmic examination (fundus examination, intraocular pressure, etc.) were performed at the 4th, 8th and 12th weekend to assess ocular safety. Imaging data obtained from OCT, fundus photography (CFP) and fluorescein angiography (FA) could also be used for ocular safety assessment. Visual acuity and intraocular pressure were measured at the first week of treatment.

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：	无	组织：
Sample Name：	None	Tissue：
人体标本去向	其它	说明
Fate of sample：	0thers	Note：

征募研究对象情况：

Recruiting status：

正在进行

Recruiting

年龄范围：

Participant age：

最小 Min age	50	岁 years
最大 Max age		岁 years

性别：

男女均可

Gender：

Both

随机方法（请说明由何人用什么方法产生随机序列）：

药物现场编盲由统计单位人员和申办单位与本试验无关人员参加，采用 SAS 9.4 输出随机表，受试者随机号与药物编号一致，根据药物编号为对应受试者进行给药。并将试验药和对照药的药物包装号粘贴在标签上。本试验药物按受试者包装，每个受试者的试验用药作为一个包装。编盲过程形成编盲记录保存。

Randomization Procedure (please state who generates the random number sequence and by what method)：

Drug field coding was performed by personnel of statistical unit and those unrelated to this study. SAS 9.4 output randomization table was adopted. The random number of subjects was consistent with the drug number, and the corresponding subjects were administered according to the drug number. And the drug package number of the test drug and the control drug will be pasted on the label. The test drug is packaged according to subject, with each subject's test drug as one package. The blind process forms blind record keeping.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

不公开/Private

盲法：	双盲，对研究参与者和研究者设盲
Blinding：	Double-blind, blinding both the research participants and the researchers

是否共享原始数据： IPD sharing	是Yes
共享原始数据的方式（说明：请填入公开原始数据日期和方式，如采用网络平台，需填该网络平台名称和网址）：	研究结束后，通过ResMan(www.medresman.org.cn)方式共享
The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：	After the end of the study, it was shared by ResMan (www.medresman.org.cn).
数据采集和管理（说明：数据采集和管理由两部分组成，一为病例记录表(Case Record Form, CRF)，二为电子采集和管理系统(Electronic Data Capture, EDC)，如ResMan即为一种基于互联网的EDC：	CRF;EDC
Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：	CRF;EDC
数据与安全监察委员会： Data and Safety Monitoring Committee：	无/No
注册人： Name of Registration：	2025-11-24 01:31:17