ChiCTR2200065341 版本V1.0 版本创建时间2022/11/03 10:16:17 中国临床试验注册中心

审核状态：

Project audit state：

通过审核

Successful

注册号：

Registration number：

 ChiCTR2200065341 

最近更新日期：

Date of Last Refreshed on：

 2022-11-02 17:27:23 

注册时间：

Date of Registration：

 2022-11-02 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

确认征募观察对象截止时间，请致电02885424855 一项在中重度非癌性慢性疼痛患者中评价NH600001乳状注射液与盐酸阿芬太尼注射液药

Public title：

A single-centre, open, randomised, three-stage, three-crossover study to evaluate the drug interaction between NH600001 lactate injection and alfentanil hydrochloride injection in patients with moderate-to-severe non-cancerous chronic pain

注册题目简写：

English Acronym：

研究课题的正式科学名称：

一项在中重度非癌性慢性疼痛患者中评价NH600001乳状注射液与盐酸阿芬太尼注射液药物相互作用的单中心、开放、随机、三阶段、三交叉研究

Scientific title：

A single-centre, open, randomised, three-stage, three-crossover study to evaluate the drug interaction between NH600001 lactate injection and alfentanil hydrochloride injection in patients with moderate-to-severe non-cancerous chronic pain

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：

张声南 

研究负责人：

阳国平、欧阳文 

Applicant：

Sheng Nan ZHANG 

Study leader：

Wen OUYANG/Guoping YANG 

申请注册联系人电话：

Applicant telephone：

 18259883227

研究负责人电话：

Study leader's
telephone：

0731-89918665

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：

 1647924956@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 ygp9880@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：

湖南省长沙市岳麓区桐梓坡路138号

研究负责人通讯地址：

湖南省长沙市岳麓区桐梓坡路138号

Applicant address：

138 Tongzipo Road,Yuelu District, Changsha, Hunan, China

Study leader's address：

138 Tongzipo Road,Yuelu District, Changsha, Hunan, China

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：

中南大学湘雅三医院临床试验研究中心

Applicant's institution：

Center for Clinical Pharmacology, the Third Xiangya Hospital of Central South University

研究负责人所在单位：

中南大学湘雅三医院临床试验研究中心

Affiliation of the Leader：

Center for Clinical Pharmacology, the Third Xiangya Hospital of Central South University

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：

 快22418

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：

中南大学湘雅三医院伦理委员会

Name of the ethic committee：

IRB, the Third Xiangya Hospital, Central South University

伦理委员会批准日期：

Date of approved by ethic committee：

 2022-10-08 00:00:00

伦理委员会联系人：

王晓敏

Contact Name of the ethic committee：

Xiaomin WANG

伦理委员会联系地址：

湖南省长沙市岳麓区桐梓坡路138号中南大学湘雅三医院伦理委员会

Contact Address of the ethic committee：

IRB, the Third Xiangya Hospital, Central South University, 138 Tongzipo Road, Yuelu District, Changsha, Hunan, China

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 731 88618938

伦理委员会联系人邮箱：

Contact email of the ethic committee：

研究实施负责（组长）单位：

中南大学湘雅三医院临床试验研究中心

Primary sponsor：

Center for Clinical Pharmacology, the Third Xiangya Hospital, Central South University

研究实施负责（组长）单位地址：

中国湖南省长沙市岳麓区桐梓坡路138号

Primary sponsor's address：

No.138 tongzipo road, Yuelu District, Changsha

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

湖南省

市(区县)：

长沙

Country：

China

Province：

Hunan

City：

Changsha

单位(医院)：

中南大学湘雅三医院临床试验研究中心

具体地址：

岳麓区桐梓坡路138号

Institution
hospital：

Center for Clinical Pharmacology, the Third Xiangya Hospital of Central South University

Address：

138 Tongzipo Road, Yuelu District, Changsha, Hunan, China

经费或物资来源：

江苏恩华药业股份有限公司

Source(s) of funding：

Jiangsu Enhua Pharmaceutical Company Limited

研究疾病：

中重度非癌性慢性疼痛  

Target disease：

Moderate-to-severe non-cancerous chronic pain

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：

 I期临床试验 

Study phase：

1

研究设计：

随机交叉对照 

Study design：

Cross-over 

研究目的：

主要目的：评价中重度非癌性慢性疼痛患者静脉注射NH600001乳状注射液与盐酸阿芬太尼注射液的药代动力学相互作用。 次要目的：评价中重度非癌性慢性疼痛患者中盐酸阿芬太尼对NH600001乳状注射液安全性和药效学的影响。  

Objectives of Study：

Primary aim: To evaluate the pharmacokinetic interaction between intravenous NH600001 emulsion injection and alfentanil hydrochloride injection in patients with moderate-to-severe non-cancerous chronic pain. Secondary objective: To evaluate the effect of alfentanil hydrochloride on the safety and pharmacodynamics of NH600001 emulsion injection in patients with moderate-to-severe non-cancerous chronic pain.

药物成份或治疗方案详述：

 

Description for medicine or protocol of treatment in detail：

 

纳入标准：

符合全部下列标准的受试者可入选本研究：
1)筛选时年龄在18～60岁（包括边界值）的男性和女性中重度非癌性慢性疼痛患者；
2)体重指数（BMI）（包括边界值）在19～26 kg/m2范围内者；
3)中重度非癌性慢性疼痛患者（如肩周炎、慢性腰背痛、肌筋膜疼痛综合征患者），疼痛评价（简明疼痛评估量表“过去24小时内疼痛的平均程度”项：0-10分）得分≥4分；
4)受试者充分理解试验的目的、内容、流程以及可能的风险后，自愿参加并签署知情同意书者；
5)能够与研究者良好沟通，愿意并能够遵守方案中规定的生活方式的限制，配合完成试验过程。

Inclusion criteria

Subjects who met all of the following criteria were eligible for enrollment in this study.
1) male and female patients with moderate to severe non-cancerous chronic pain aged 18 to 60 years (including borderline values) at the time of screening
2) Those with a body mass index (BMI) (including borderline values) in the range of 19 to 26 kg/m2.
3) Patients with moderate-to-severe non-cancerous chronic pain (e.g. patients with frozen shoulder, chronic low back pain, myofascial pain syndrome) with a score of ≥4 on the pain scale (Brief Pain Assessment Scale "average level of pain in the past 24 hours": 0-10).
4) Subjects who have fully understood the purpose, content, procedure and possible risks of the trial and who have voluntarily signed an informed consent form to participate.
5) The subject is able to communicate well with the investigator and is willing and able to comply with the lifestyle restrictions set out in the protocol and cooperate in the completion of the trial.

排除标准：

如果受试者符合一条或多条下列标准，不得参加本研究：
1)研究者判定受试者现病史和既往史存在影响临床试验的疾病或功能障碍，包括但不限于中枢神经系统、心血管系统、呼吸系统、消化系统、泌尿系统、内分泌系统、血液和淋巴系统慢性或严重疾病史、精神疾病者；
2)全身体格检查、生命体征、血常规、血生化（包括但不限于：谷丙转氨酶（ALT）、肌酐（Cr）、尿素氮（BUN）或尿素超出正常上限1.5倍者、空腹血糖＜3.9或＞6.1mmol/L或血钾＞5.3mmol/L者）、尿常规、凝血功能、全胸正位片、腹部B超检查结果异常且具有临床意义者；皮质醇和ACTH整体节律或检测值研究者判定异常且具有临床意义者；
3)已知对依托咪酯、阿片类、丙泊酚、纳洛酮或其他麻醉药物及其类似药物组分、大豆、花生、鸡蛋或蛋类产品等过敏者，或为过敏体质（对两种及以上药物、环境或食物过敏）者，或易发生皮疹、荨麻疹等体质者，或有过敏性疾病病史者；
4)有麻醉意外史、麻醉严重不良反应史或家族麻醉意外史者；
5)既往有通气困难或怀疑是困难气道或预估气管插管困难者（比如改良的Mallampti评分Ⅲ-Ⅳ级，先天性口小舌大、下颌骨发育不良等）；
6)既往或目前有支气管哮喘、慢性阻塞性肺病、睡眠呼吸暂停综合征等气道疾病者；
7)有肾上腺皮质功能不全病史或肾上腺肿瘤或遗传性血红素生物合成障碍病史或遗传性急性卟啉症者；
8)在筛选时发现具有临床意义的心电图异常，包括但不限于 QTcF≥ 450 毫秒（男性）或≥ 470 毫秒（女性）；
9)筛选前1年内有药物滥用史、药物依赖史、毒品滥用史者，或尿药物筛查（吗啡、甲基安非他明、氯胺酮、四氢大麻酚酸和亚甲二氧基甲基安非他明）呈阳性者；
10)筛选前6个月内有酒精滥用史（即每周饮酒超过14个标准单位（1单位=360 mL啤酒或45 mL酒精量为40%的烈酒或150 mL葡萄酒）或酒精呼气试验阳性（结果>0），或试验期间不能禁酒者；
11)烟检结果阳性，或筛选前6个月内嗜烟（每日吸烟量≥5支），或在试验期间无法戒烟（包括使用尼古丁口香糖或透皮尼古丁贴）者；
12)试验用药品首次给药前48小时内，摄入含咖啡因的食物或饮料（如，咖啡、浓茶、巧克力和含咖啡因的碳酸饮料、可乐等）者；
13)试验用药品首次给药前48小时内，摄入过任何富含葡萄柚的饮料或食物者；
14)对食物有特殊要求，不能遵守统一饮食或有吞咽困难者；或平时厌食、节食或筛选前4周内已经开始了显著不正常的饮食（如节食、低钠）者；
15)采血困难、不能耐受静脉穿刺和/或有晕血、晕针史者；
16)筛选期处在怀孕或哺乳期妇女；以及在整个研究期间及研究结束后3个月内拒绝采取有效的非药物避孕措施（如禁欲、宫内节育器），或有捐精或捐卵计划者；
17)试验用药品首次给药前1个月内使用过任何抑制或诱导肝药酶的药物(如：诱导剂—苯巴比妥、利福平、卡马西平、苯妥英、地塞米松等；抑制剂—氟伏沙明、S-美芬妥英、丙泊酚、异烟肼、吩噻嗪等)者；
18)乙型肝炎表面抗原（HBsAg）、丙型肝炎抗体（HCV-Ab）、HIV抗体（HIV-Ab）、梅毒螺旋体（TP）抗体检测非阴性者；
19)在给药前3个月内参与过任何临床试验者或仍处于其他试验随访期者；
20)筛选前1个月内接受过灭活疫苗接种，筛选前3个月内接受过活/减毒疫苗接种或计划在试验期间接受灭/活/减毒疫苗接种者；
21)筛选前3个月内有过失血或献血总量超过400 mL，或试验前3个月内输血或接受过血液制品总量超过400 mL，或计划在试验期间或试验结束后1个月内献血或接受手术者；
22)筛选前3个月内有手术史，或未从手术中康复，或者在试验期间有预期手术计划者；
23)筛选前2周内服用任何药物者，包括处方药、非处方药和中草药等；筛选前6个月内使用过阿片类镇痛药者；试验用药品首次给药前5日内使用过镇静/镇痛药或其他麻醉药物者；
24)预计依从性差或研究者认为不适合参加研究的其他情况。

Exclusion criteria：

Subjects may not participate in this study if they meet one or more of the following criteria.
1) The investigator determines that the subject has a current and past history of disease or dysfunction that would interfere with the clinical trial, including, but not limited to, a history of chronic or severe disease of the central nervous system, cardiovascular system, respiratory system, digestive system, urinary system, endocrine system, hematologic and lymphatic system, or psychiatric disease.
2) abnormalities in general physical examination, vital signs, routine blood count, blood biochemistry (including but not limited to: glutamate transaminase (ALT), creatinine (Cr), urea nitrogen (BUN) or urea exceeding 1.5 times the upper limit of normal, fasting blood glucose <3.9 or >6.1 mmol/L or blood potassium >5.3 mmol/L), urinary routine, coagulation function, whole chest orthopantomogram, abdominal ultrasound who have clinically significant findings; cortisol and ACTH global rhythms or assay values judged abnormal by the investigator and clinically significant.
3) persons with known allergy to etomidate, opioids, propofol, naloxone or other narcotic drugs and their similar drug components, soy, peanuts, eggs or egg products, or who are allergic (allergic to two or more drugs, the environment or food), or who are prone to rashes, urticaria, etc., or who have a history of allergic disease
4) those with a history of anaesthetic accidents, a history of severe adverse reactions to anaesthesia or a family history of anaesthetic accidents
5) those with previous ventilation difficulties or suspected difficult airway or predicted difficult tracheal intubation (e.g. modified Mallampti score grade III-IV, congenital small mouth and large tongue, mandibular dysplasia, etc.)
6) those with previous or current airway disease such as bronchial asthma, chronic obstructive pulmonary disease, sleep apnoea syndrome
7) those with a history of adrenocortical insufficiency or adrenal tumours or a history of hereditary disorders of haemoglobin biosynthesis or hereditary acute porphyria
8) clinically significant ECG abnormalities detected at screening, including but not limited to QTcF ≥ 450 msec (men) or ≥ 470 msec (women)
9) Persons with a history of substance abuse, drug dependence, drug abuse, or a positive urine drug screen (morphine, methamphetamine, ketamine, tetrahydrocannabinol acid and methylenedioxymethamphetamine) within 1 year prior to screening
10) those with a history of alcohol abuse (i.e. drinking more than 14 standard units of alcohol per week (1 unit = 360 mL of beer or 45 mL of spirits at 40% alcohol or 150 mL of wine) or a positive alcohol breath test (result >0) within the 6 months prior to screening, or who are unable to abstain from alcohol during the test
11) those who have a positive result on a smoke test, or who have been addicted to smoking (≥5 cigarettes per day) in the 6 months prior to screening, or who are unable to abstain from smoking (including use of nicotine gum or transdermal nicotine patches) during the trial
12) Those who have ingested caffeine-containing foods or beverages (e.g., coffee, strong tea, chocolate and caffeine-containing carbonated beverages, cola, etc.) within 48 hours prior to the first dose of the test drug
13) Persons who have ingested any grapefruit-rich beverage or food within 48 hours prior to the first administration of the test drug.
14)persons with special food requirements, who are unable to comply with a uniform diet or who have difficulty swallowing; or who are normally anorexic, on a diet or have started a significantly abnormal diet (e.g. dieting, low sodium) within 4 weeks prior to screening
15) those who have difficulty collecting blood, cannot tolerate venipuncture and/or have a history of blood or needle sickness
16) women who are pregnant or breastfeeding during the screening period; and those who refuse to use effective non-pharmacological contraception (e.g. abstinence, IUD) throughout the study and for 3 months after the end of the study, or who have plans to donate sperm or eggs
17) Those who have used any drug that inhibits or induces hepatic enzymes (e.g. inducers - phenobarbital, rifampicin, carbamazepine, phenytoin, dexamethasone, etc.; inhibitors - fluvoxamine, S-mefenthol, propofol, isoniazid, phenothiazine, etc.) within 1 month prior to the first dose of the trial drug.
18) Persons who have tested non-negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody (HCV-Ab), HIV antibody (HIV-Ab), syphilis spirochete (TP) antibody.
19) Those who have participated in any clinical trial within 3 months prior to dosing or those who are still in the follow-up period of other trials.
20) who have received inactivated vaccination within 1 month prior to screening, live/attenuated vaccination within 3 months prior to screening or who are scheduled to receive inactivated/live/attenuated vaccination during the trial
21) who have had blood loss or donated more than 400 mL of blood in total within 3 months prior to screening, or who have had a transfusion or received more than 400 mL of blood products in total within 3 months prior to the trial, or who are scheduled to donate blood or undergo surgery during or within 1 month of the trial
22) those who have a history of surgery within 3 months prior to screening, or have not recovered from surgery, or have anticipated surgery planned during the trial
23) those who have taken any medication, including prescription, over-the-counter and herbal medicines, within 2 weeks prior to screening; those who have used opioid analgesics within 6 months prior to screening; those who have used sedative/analgesic or other narcotic drugs within 5 days prior to the first dose of the trial drug
24) Poor adherence is expected or other conditions that the investigator considers unsuitable for study participation.

研究实施时间：

Study execute time：

从 From 2022-11-01 00:00:00至 To 2025-11-10 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2022-11-02 00:00:00 至 To 1990-01-01 00:00:00

干预措施：

Interventions：

组别：

A组

样本量：

 5

Group：

A

Sample size：

干预措施：

在D1空腹静脉泵入NH600001乳状注射液1 min，一次0.3mg/kg；在D8空腹静脉推注阿芬太尼20s，一次5.0μg/kg；在D15空腹静脉推注阿芬太尼5.0μg/kg 20s后静脉泵入NH600001乳状注射液1min，一次0.3mg/kg

干预措施代码：

Intervention：

In D1 intravenous pump of NH600001 emulsion for 1 min at 0.3mg/kg once; in D8 intravenous push of alfentanil for 20s at 5.0μg/kg once; in D15 intravenous push of alfentanil at 5.0μg/kg for 20s then intravenous pump of NH600001 emulsion for 1 min at 0.3mg/kg once

Intervention code：

组别：

B组

样本量：

 5

Group：

B

Sample size：

干预措施：

在D1空腹静脉推注阿芬太尼20s，一次5.0μg/kg；在D8空腹静脉推注阿芬太尼5.0μg/kg 20s后静脉泵入NH600001乳状注射液1min，一次0.3mg/kg；在D15空腹静脉泵入NH600001乳状注射液1 min，一次0.3mg/kg

干预措施代码：

Intervention：

5.0μg/kg once by intravenous push of alfentanil for 20s in D1; 5.0μg/kg by intravenous push of alfentanil for 20s in D8 followed by 0.3mg/kg once by intravenous pump of NH600001 emulsion for 1min; 0.3mg/kg once by intravenous pump of NH600001 emulsion for 1min in D15

Intervention code：

组别：

C组

样本量：

 5

Group：

C

Sample size：

干预措施：

在D1空腹静脉推注阿芬太尼5.0μg/kg 20s后静脉泵入NH600001乳状注射液1min，一次0.3mg/kg；在D8空腹静脉泵入NH600001乳状注射液1 min，一次0.3mg/kg；在D15空腹静脉推注阿芬太尼20s，一次5.0μg/kg

干预措施代码：

Intervention：

In D1, 5.0μg/kg of alfentanil was administered intravenously for 20s followed by 0.3mg/kg of NH600001 emulsion for 1min; in D8, 0.3mg/kg of NH600001 emulsion was administered intravenously for 1min; in D15, 5.0μg/kg of alfentanil was administered intravenously for 20s

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 湖南 

市(区县)：

  

Country：

China

Province：

Hunan

City：

单位(医院)：

 中南大学湘雅三医院 

单位级别：

 三级甲等 

Institution
hospital：

Xiangya Third Hospital, Central South University

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

血浆浓度

指标类型：

主要指标

Outcome：

Plasma concentration

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

体格检查

指标类型：

主要指标

Outcome：

physical examination

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

生命体征

指标类型：

主要指标

Outcome：

vital signs

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

实验室检查

指标类型：

主要指标

Outcome：

laboratory test

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

12导联心电图

指标类型：

主要指标

Outcome：

12-lead ECG

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

不良事件

指标类型：

副作用指标

Outcome：

adverse event

Type：

Adverse events

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

心电监护

指标类型：

主要指标

Outcome：

Cardiac monitoring

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

脉搏血氧饱和度

指标类型：

主要指标

Outcome：

Pulse oximetry

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

血浆皮质醇、促肾上腺皮质激素（ACTH）浓度

指标类型：

主要指标

Outcome：

Plasma cortisol and adrenocorticotropic hormone (ACTH) concentrations

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

改良警觉镇静评分（MOAA/S）

指标类型：

主要指标

Outcome：

Modified Alerated Alertness Sedation Score (MOAA/S)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

脑电双频谱指数（BIS）

指标类型：

主要指标

Outcome：

EEG Bispectral Index (BIS)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

11分数字评定量表（NRS）

指标类型：

主要指标

Outcome：

11-point numerical rating scale (NRS)

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

采集人体标本：

Collecting sample(s)
from participants：

标本中文名：

血浆

组织：

Sample Name：

blood

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

标本中文名：

尿液

组织：

Sample Name：

unine

Tissue：

人体标本去向

 使用后销毁  

说明

Fate of sample：

Destruction after use  

Note：

征募研究对象情况：

Recruiting status：

尚未开始

Not yet recruiting

年龄范围：

Participant age：
最小 Min age 18 岁 years
最大 Max age 60 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）：

在研究中的每名受试者每阶段接受试验用药品（NH600001、阿芬太尼）的顺序将由随机表确定。随机表是由江苏恩华药业股份有限公司或其委托的统计人员使用SAS软件包生成，按照方案规定的A组、B组和C组受试者的比例产生足够数量的随机号。 在基线期，受试者经评估符合入组要求后进入随机。在随机时每名合格的受试者按照筛选号从小到大的顺序获得随机号。

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

The order in which each subject in the study will receive the trial drug (NH600001, alfentanil) in each phase will be determined by a randomisation table. The randomisation table is generated by Jiangsu Enhua Pharmaceutical Company Limited or its commissioned statisticians using the SAS software package to gene

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：

Blinding：

是否共享原始数据：

IPD sharing

否No

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）：

文章发表

The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url)：

Articles published

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：

本次试验数据管理采用电子数据采集系统（EDC），由浙江太美医疗科技股份有限公司提供电子数据采集系统（eCollect ? V5）。电子病例报告表（eCRF）：数据管理员根据试验方案设计构建，并根据数据核查计划（DVP）设置逻辑核查，通过测试并获申办方批准后发布使用。 数据录入：eCRF数据来源于原始记录，由数据录入人员根据eCRF填写说明，将志愿者访视数据及时录入 EDC。

Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture：

The electronic data capture (EDC) system (eCollect ? V5) was provided by Zhejiang Taimei Medical Technology Co. Electronic Case Report Form (eCRF): The data manager designed and constructed the eCRF according to the trial protocol and set up logical verification according to the Data Verification Plan (DVP), which was tested and approved by the sponsor before being released for use. Data entry: The eCRF data is derived from the original records and is entered into the EDC in a timely manner by the data entry staff according to the eCRF completion instructions for volunteer visits.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2022-11-02 17:27:23