ChiCTR2300071751 版本V1.0 版本创建时间2023/05/24 11:08:45 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：

 ChiCTR2300071751 

最近更新日期：

Date of Last Refreshed on：

 2023-05-24 11:08:24 

注册时间：

Date of Registration：

 2023-05-24 00:00:00 

注册号状态：

预注册

Registration Status：

Prospective registration

注册题目：

一项评估乙醇注射液在舌部静脉畸形患者中安全性与有效性的临床研究

Public title：

A clinical study to evaluate the safety and efficacy of ethanol injection in patients with lingual venous malformations

注册题目简写：

乙醇注射液治疗舌静脉畸形

English Acronym：

Treatment of lingual venous malformations by ethanol injection

研究课题的正式科学名称：

一项评估乙醇注射液在舌部静脉畸形患者中安全性与有效性的临床研究

Scientific title：

A clinical study to evaluate the safety and efficacy of ethanol injection in patients with lingual venous malformations

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：

沈禹辰 

研究负责人：

王德明 

Applicant：

Yuchen Shen 

Study leader：

Deming Wang 

申请注册联系人电话：

Applicant telephone：

 +86 186 4613 2483

研究负责人电话：

Study leader's
telephone：

+86 199 2191 5928

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：

 1216151249@qq.com

研究负责人电子邮件：

Study leader's E-mail：

 wdmdeming@hotmail.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：

上海市黄浦区制造局路833弄18号

研究负责人通讯地址：

上海市黄浦区制造局路639号

Applicant address：

No.18, Lane 833, Zhi Zao Ju Rd, Huangpu District, Shanghai

Study leader's address：

No.639, Zhi Zao Ju Rd, Huangpu District, Shanghai

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：

上海交通大学医学院附属第九人民医院

Applicant's institution：

Shanghai Jiao Tong University School of Medicine Affiliated Ninth People‘s Hospital

研究负责人所在单位：

上海交通大学医学院附属第九人民医院

Affiliation of the Leader：

Shanghai Jiao Tong University School of Medicine Affiliated Ninth People‘s 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：

 SH9H-2023-T132-2

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：

上海交通大学医学院附属第九人民医院伦理委员会

Name of the ethic committee：

Institutional review board of Shanghai Jiao Tong University School of Medicine Affiliated Ninth People‘s Hospital

伦理委员会批准日期：

Date of approved by ethic committee：

 2023-05-19 00:00:00

伦理委员会联系人：

甄红

Contact Name of the ethic committee：

Hong Zhen

伦理委员会联系地址：

上海市制造局路 639 号

Contact Address of the ethic committee：

No.639, Zhi Zao Ju Rd, Huangpu District, Shanghai

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 21 2327 1699

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：

上海交通大学医学院附属第九人民医院

Primary sponsor：

Shanghai Jiao Tong University School of Medicine Affiliated Ninth People‘s Hospital

研究实施负责（组长）单位地址：

上海市黄浦区制造局路639号

Primary sponsor's address：

No.639, Zhi Zao Ju Rd, Huangpu District, Shanghai

试验主办单位(项目批准或申办者)：

Secondary sponsor：

国家：

中国

省(直辖市)：

上海市

市(区县)：

Country：

China

Province：

Shanghai

City：

单位(医院)：

上海交通大学医学院附属第九人民医院

具体地址：

上海市黄浦区制造局路639号

Institution
hospital：

Shanghai Jiao Tong University School of Medicine Affiliated Ninth People‘s Hospital

Address：

No.639, Zhi Zao Ju Rd, Huangpu District, Shanghai

经费或物资来源：

上海九院横向课题项目（JYHX2022007）

Source(s) of funding：

Transverse Research Project of Shanghai Ninth People's Hospital (No. JYHX2022007)

研究疾病：

外周静脉畸形  

Target disease：

Peripheral venous malformations

研究疾病代码：

LA90.2

Target disease code：

LA90.2

研究类型：

治疗研究

Study type：

Treatment study

研究所处阶段：

 探索性研究/预试验 

Study phase：

0

研究设计：

单臂 

Study design：

Single arm 

研究目的：

主要目的：评估乙醇注射液治疗普通静脉畸形患者的安全性； 次要目的：评估乙醇注射液治疗普通静脉畸形患者的有效性。  

Objectives of Study：

Main purpose: To evaluate the safety of ethanol injection in the treatment of patients with lingual venous malformations. Secondary purpose: To evaluate the efficacy of ethanol injection in the treatment of patients with lingual venous malformations.

药物成份或治疗方案详述：

研究药物：乙醇注射液 乙醇体积分数：80% 治疗方案： 术前准备及预处理： 根据术前影像学检查进行病灶定位，进行开放静脉通道、术区消毒、全身麻醉、吸氧和液体支持等常规术前操作。 治疗前10 min所有受试者静脉推注地塞米松10 mg进行预处理。 乙醇治疗： 必须由具备5年及以上乙醇硬化治疗脉管畸形手术经验的专科医生进行操作。在病变中心和最接近体表位置，尽可能避让重要神经和血管，采用21G/18G蝶形针穿刺，回抽见静脉血表明穿刺成功。采用“双针技术”（当通过其中一根穿刺针注射乙醇时，第2针可以引出过量的乙醇和血液，避免乙醇过度充盈于病变内，此外也通过部分血液与乙醇的置换过程，加强乙醇与病变内皮的接触），根据临床需求也可多针穿刺。 在DSA（FD20， PHILIPS，Amsterdam， Netherlands；IGS530，GE，USA）监视下，通过穿刺针注射碘普罗胺注射液行动态静脉造影，确保穿刺针头位于病灶腔内，同时了解病变范围和引流静脉情况，评估病灶Puig分型，接受单次乙醇注射液硬化治疗。根据造影剂充满病灶、流出病灶的情况并结合术前MRI估算的病灶体积，评估乙醇注射液的合适用量（受试者总用量不得超过10 ml）。 随后，在DSA监视下，缓慢注射乙醇注射液，观察充盈效果，随时调整注射压力和速度，乙醇注射液完整充盈病灶即停止注射。必要时多点穿刺注射。 在注射乙醇注射液期间，通过心电监护仪持续监测生命体征。 术后治疗： 术后继续进行生命体征监测至少4小时，按照医院常规予止痛、消肿和静脉补液等其他术后治疗。 

Description for medicine or protocol of treatment in detail：

Study drug: ethanol injection Ethanol volume fraction: 80% Therapeutic schedule: Preoperative preparation and pretreatment: According to the preoperative imaging examination, the focus was located, and routine preoperative operations such as open venous channels, operative area disinfection, general anesthesia, oxygen inhalation, and fluid support were performed. 10 min before treatment, all subjects were pretreated by intravenous injection of dexamethasone 10 mg. Ethanol treatment: A specialist must perform it with at least five years of experience treating vascular malocclusion with anhydrous ethanol. In the center of the lesion and the position closest to the body surface, the important nerves and blood vessels were avoided as far as possible. 21G/18G butterfly needle was used for puncture. Venous blood was found in the pulled-back, indicating a successful puncture. Using the "two-needle technique" (when one of the puncture needles is injected with Iopromide-ethanol, the second needle can elicit excessive ethanol and blood to avoid excessive filling of ethanol in the lesion, and in addition, the contact between ethanol and the lesion endothelium can be strengthened through the replacement process of partial blood and ethanol), multiple needle puncture can also be used according to clinical requirements. In DSA (FD20, PHILIPS, Amsterdam, Netherlands; IGS530, GE, USA), dynamic venography was performed by injecting iopromide injection with a puncture needle to ensure the puncture needle head was located in the focal cavity. The lesion scope and drainage vein were understood simultaneously, and the focal Puig classification was evaluated. Patients with type Ⅰ and Ⅱ received single sclerotherapy with ethanol injection. Ethanol injection (total dosage of subjects should not exceed 10 ml) was evaluated based on the filling and outflow of contrast agent in the lesion and the lesion volume estimated by preoperative MRI. After that, the injection was slowly injected under the supervision of DSA, and the filling effect was observed. The injection pressure and speed were adjusted at any time, and the injection was stopped once the lesion was filled. Multipoint puncture injection if necessary. ECG monitor continuously monitored vital signs during the injection of Iopromide-ethanol injection; Arterial blood pressure was monitored by peripheral arterial puncture with an indwelling catheter, and ETCO2 (end-expiratory carbon dioxide) monitor was used to monitor ETCO2. Postoperative treatment: Vital signs should be monitored for at least 4 hours after surgery, and other postoperative treatments such as analgesia, deswelling, and intravenous fluid replacement should be given according to the hospital routine. 

纳入标准：

受试者必须符合以下所有研究入选标准：
1. 自愿参加本次临床试验并签署ICF，理解并遵循研究程序；
2. 受试者签署知情同意书当天≥18周岁且<65岁，男女不限；
3. 体重指数（BMI，按BMI=体重[kg]/身高2[m2]计算）在18.5~28.0 kg/m2（包括边界值）范围内；
4. 经磁共振成像（MRI）确诊的静脉畸形（ISSVA，2018），且满足以下条件：
a) 普通静脉畸形；
b) 单发病灶；
c) 病灶在MRI下可测量（病灶最短直径≥10 mm），轮廓清楚，且最大径线≤5 cm；
d) 不适合观察或保守治疗，或经观察、保守治疗症状加重，经研究者评估有硬化治疗指征；
e) 病灶表面无溃疡、感染、出血等并发症发生；
5. 治疗前3个月内未接受过针对本研究拟治疗的静脉畸形病灶的治疗，包括但不限于手术治疗、硬化治疗、激光治疗、冷冻消融、射频消融和靶向治疗（如雷帕霉素），保守性治疗（如加压治疗）和对症治疗（如止痛、抗凝）除外。
6. 具有适当的器官功能：
a) 血常规各项指标均正常或异常无临床意义；
b) 天冬氨酸转氨酶（AST）/丙氨酸转氨酶（ALT）≤2.5×正常值上限（ULN），总胆红素≤1.5×ULN，基线白蛋白≥30 g/L；
c) 根据机构标准实践评估计算的肌酐清除率≥50 mL/min（根据Cockcroft-Gault公式）。

Inclusion criteria

Inclusion criteria
Subjects must meet all of the following study inclusion criteria:
1. Voluntarily participate in the clinical trial, sign the ICF, understand and follow the study procedures;
2. The subject is ≥18 years old and <65 years old on the date of signing the informed consent, regardless of gender;
3. Body mass index (BMI, calculated by BMI= weight [kg]/ height 2[m2]) within the range of 18.5~28.0 kg/m2 (including boundary values);
4. Venous malformations diagnosed by magnetic resonance imaging (ISSVA, 2018) with the following conditions:
a) Common venous malformations of the tongue;
b) single lesion;
c) The lesion can be measured under MRI (the shortest diameter of the lesion is ≥10 mm), the contour is clear, and the maximum diameter line is ≤5 cm;
d) It is not suitable for observation or conservative treatment, or the symptoms get worse after observation or conservative treatment, and the investigator has assessed indications of sclerotherapy;
e) No complications such as ulceration, infection and bleeding occurred on the lesion surface;
5. No treatment for the venous malformation lesions to be treated in this study was received within 3 months prior to treatment, including but not limited to surgical therapy, sclerotherapy, laser therapy, cryoablation, radiofrequency ablation, and targeted therapy (e.g. Rapamycin), except conservative therapy (e.g. Compression therapy) and symptomatic therapy (e.g., analgesia and anticoagulation).
6. Have proper organ function:
a) All indicators of blood routine are normal or abnormal and have no clinical significance;
b) Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤2.5× upper limit of normal (ULN), total bilirubin ≤1.5×ULN, baseline albumin ≥30 g/L;
c) Creatinine clearance ≥50 mL/min as calculated from institutional standard practice assessment (based on the Cockcroft-Gault formula, see Appendix 2).

排除标准：

符合以下任一标准的受试者将被排除： 1. 患有任何其他类型的脉管畸形，如：微静脉畸形，动静脉畸形，淋巴管畸形者； 2. 累及胃肠道、肌肉、骨质、关节或神经系统的静脉畸形； 3. 患有混合性、复杂静脉畸形或静脉畸形合并其他病变的患者（例如毛细血管-静脉畸形、淋巴管-静脉畸形、毛细血管-淋巴管-静脉畸形、毛细血管-静脉-动静脉畸形、毛细血管-淋巴管-静脉-动静脉畸形、疣状静脉畸形、家族性皮肤粘膜静脉畸形、蓝色橡皮疱痣综合征、球形细胞静脉畸形、Klippel-Trenaunay综合征和Maffucci综合征）； 4. 经皮穿刺途径无法到达病灶的深部静脉畸形患者； 5. 广泛浅表静脉畸形经研究中评估治疗后皮肤坏死风险高的患者； 6. 存在颅内血管交通支的静脉畸形； 7. 病灶部位在舌根、口底、喉咽、咽旁、软腭和颈部等部位，为了维持上呼吸道通畅，预计术前需行预防性气管切开，或术中需紧急气管切开，或术后需保留气管插管≥48小时的患者； 8. 有碘造影剂过敏史、乙醇过敏史的患者； 9. 活动性感染者： a) 活动性乙型肝炎病毒（HBV）或丙型肝炎病毒（HCV）感染； 筛选期乙肝病毒表面抗原（HBsAg）阳性和/或HCV抗体阳性的受试者，须进行HBV DNA和/或HCV RNA检测。HBV DNA<最低检测下限和/或HCV RNA<最低检测下限的受试者方可入组； b) 已知人类免疫缺陷病毒（HIV）感染或获得性免疫缺陷综合征（AIDS）病史； c) 梅毒螺旋体抗体（TP-Ab）阳性（TP-Ab阳性者行快速血浆反应素试验[RPR]或甲苯胺红不加热血清试验[TRUST]确认为阴性者允许入组）； d) 其他活动性感染，包括治疗前7天内需静脉给予抗感染治疗的如急性肺炎、不明原因持续发热等； 10. 伴有严重的全身疾病，难以耐受全麻手术者，包括但不限于： a) 充血性心力衰竭（纽约心脏协会[NYHA] Ⅲ/Ⅳ级心脏衰竭，见附录3）或左室射血分数（LVEF）<50%； b) 给药前6个月内发生心肌梗塞、严重或不稳定心绞痛、脑卒中、肺栓塞、动脉血栓及深静脉血栓； c) 肺动脉高压、右向左分流； d) 未控制的室性心律失常；以Fridericia公式（QTcF=QT??RR，RR为标准化心率值，根据60除以心率得到）计算QTc间期男性≥450 ms，女性≥470 ms，或有QT间期延长综合征，或患有可能导致QT间期延长的合并疾病； e) 不能通过抗高血压药物很好地控制的高血压（收缩压≥160 mmHg和/或舒张压≥110 mmHg）； f) 无法控制的糖尿病、甲状腺疾病或其他内分泌系统疾病； g) 蛋白尿≥（++）时进一步测定24小时尿总蛋白>1.0 g； h) 凝血功能异常（任何一项异常：凝血酶原时间[PT]较ULN延长>3 s，活化部分凝血活酶时间[APTT]较ULN延长>10 s，国际标准化比值[INR]>2.0，纤维蛋白原<正常值下限[LLN]），或有出血倾向，或正在接受溶栓治疗，或正在接受抗凝治疗，或确诊为局限性血管内凝血（LIC）； 11. 具有生育能力的女性受试者治疗前3天内血清妊娠试验为阳性； 12. 具有生育能力的女性和有生育能力伴侣的男性不能在研究期间使用充分的屏障避孕方法进行避孕或避免同房； 13. 治疗前28天内进行过大手术或其他脏器介入、消融治疗等； 14. 治疗前28天内接种过活疫苗或减毒活疫苗，允许使用不含活病毒的季节性流感疫苗； 15. 筛选前3个月内参加过其他临床试验者（以末次使用研究药物时间为准）； 16. 治疗前5年内有恶性肿瘤病史，除非仅通过手术治愈并持续无病生存； 17. 研究人员认为可能会损害受试者的权利、安全、福利或签署ICF、合作和参与研究的能力，或会干扰结果解释的任何其他医疗、精神或社会状况。

Exclusion criteria：

Exclusion criteria Subjects who meet any of the following criteria will be excluded: 1. Patients with any other type of vascular malformations, such as capillary malformations, arteriovenous malformations, and lymphatic malformations; 2. Venous malformations involving the gastrointestinal tract, muscles, bones, joints, or nervous system; 3. Patients with mixed, complex venous malformations or venous malformations with other lesions (e.g., capillary-venous malformations, lymphatic-venous malformations, capillary-lymphatic-venous malformations, capillary-venous arteriovenous malformations, capillary-lymphatic-venous arteriovenous malformations, warty venous malformations, familial cutaneous mucous venous malformations, blue erases Blister nevus syndrome, spherical cell venous malformation, Klippel-Trenaunay syndrome, and Maffucci syndrome); 4. Patients with deep venous malformations whose lesions could not be reached by a percutaneous puncture; 5. Patients with extensive superficial venous malformations assessed in studies as having a high risk of skin necrosis after treatment; 6. The presence of intracranial venous malformations in the communicating branches of the vessels; 7. The lesions were located at the base of the tongue, the bottom of the mouth, the larynx, the pharynx, the parapharynx, the soft palate and neck, etc. To maintain the patency of the upper respiratory tract, it was estimated that prophylactic tracheotomy was required before surgery, emergency tracheotomy was needed during surgery, or tracheal intubation was reserved for ≥48 hours after surgery. 8. Patients with an allergic history of iodine contrast agent and ethanol; 9. Actively infected persons: a) Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection; During the screening period, subjects who are HBV surface antigen (HBsAg) positive and HCV antibody positive shall be tested for HBV DNA and HCV RNA. Subjects with HBV DNA< lower limit for detection and HCV RNA< lower limit for detection can be enrolled; b) Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS); c) Treponema pallidum antibody (TP-Ab) positive (TP-Ab positive patients confirmed negative by rapid plasma reagin test [RPR] or toluidine red unheated serum test [TRUST] were admitted into the group); d) Other active infections, including those requiring intravenous anti-infective therapy, such as acute pneumonia and unexplained persistent fever seven days before treatment; 10. Patients with severe systemic diseases that make it difficult to tolerate general anesthesia, including but not limited to: a) Congestive heart failure (New York Heart Association [NYHA] Grade Ⅲ/Ⅳ heart failure, see Appendix 3) or left ventricular ejection fraction (LVEF) <50%; b) Myocardial infarction, severe or unstable angina pectoris, stroke, pulmonary embolism, arterial thrombosis, and deep vein thrombosis occurred within six months before administration; c) Pulmonary hypertension, right-to-left shunt; d) Uncontrolled ventricular arrhythmias; To Fridericia formula (QTcF = QT / ? RR, RR for standardized heart rate value, according to the divided by the heart rate of 60) calculation of QTc interphase male 450 ms, or women acuity 470 ms, or long QT syndrome, or may result in prolonged QT merger illness; e) Hypertension that is not well controlled with antihypertensive medications (systolic blood pressure ≥160 mmHg and diastolic blood pressure ≥110 mmHg); f) Uncontrolled diabetes, thyroid disease, or other endocrine system disorders; g) Albuminuria ≥ (++) was further measured at 24 hours of total urinary protein >1.0 g; h) Abnormal clotting function (any of these abnormalities: Prothrombin time [PT] >3 s longer than ULN, activated partial thrombin time [APTT] >10 s longer than ULN, international normalized ratio [INR]>2.0, fibrinogen < lower limit of normal [LLN]), bleeding tendency, receiving thrombolytic therapy, or receiving anticoagulation treatment, Or a diagnosis of localized intravascular coagulation (LIC); 11. The serum pregnancy test of fertile female subjects was positive within three days before treatment; 12. Fertile women and men with fertile partners were unable to use adequate barrier contraceptive methods for contraception or to avoid sex during the study period; 13. Major surgery or other organ intervention and ablation within 28 days before treatment; 14. Seasonal influenza vaccine that does not contain the live virus is allowed if it has been vaccinated with the live or attenuated vaccine within 28 days before treatment; 15. Participants who participated in other clinical trials within three months before screening (based on the time of last use of the study drug); 16. History of the malignant tumor within five years before treatment, unless cured only by surgery and sustained disease-free survival; 17. Any other medical, mental, or social condition that the investigator considers likely to impair the subject's rights, safety, welfare, or ability to sign an ICF, cooperate, and participate in the study or that would interfere with the interpretation of the results.

研究实施时间：

Study execute time：

从 From 2023-06-01 00:00:00至 To 2023-08-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2023-06-01 00:00:00 至 To 2023-06-30 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 5

Group：

Test group

Sample size：

干预措施：

乙醇硬化治疗

干预措施代码：

Intervention：

Ethanol sclerotherapy

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 上海市 

市(区县)：

  

Country：

China

Province：

Shanghai

City：

单位(医院)：

 上海交通大学医学院附属第九人民医院 

单位级别：

 三级甲等 

Institution
hospital：

Shanghai Jiao Tong University School of Medicine Affiliated Ninth People‘s Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

安全性

指标类型：

主要指标

Outcome：

Safety

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

病灶大小

指标类型：

次要指标

Outcome：

The size of lesion

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

临床症状评分

指标类型：

次要指标

Outcome：

Clinical Symptom Score

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

总体疗效

指标类型：

次要指标

Outcome：

Overall efficacy

Type：

Secondary 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：

血液

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：

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 65 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）：

非随机实验

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

Non-random trial

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）：

无

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

N/A

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：

本研究项目团队中设立研究者、监查员、数据管理员等不同岗位, 并对参与者进行培训。研究者在采集数据时以电子病例报告表的形式采集受试者信息，保证数据的准确、完整与及时性。监察员根据电子病历源文件核查信息收集表中的数据，一旦发现其中有错误或差异，应通知研究者，并根据所发现的错误或差异，记录相应的质疑，以确保所有数据的记录和报告正确和完整。数据管理员则按照研究方案的要求，建立电子数据库、对数据标准进行管理、并建立和测试逻辑检验程序。在信息收集表数据被纳入数据库后，利用逻辑检验程序检查数据的有效性、一致性、缺失和正常值范围等。数据管理员对发现的问题应及时清理，可通过向研究者发放数据质疑而得到解决。

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

In this research project team, different positions such as researcher, supervisor, and data administrator were set up, and participants were trained. When collecting data, the researcher collects the information of the subjects in the form of an electronic Case Record Form to ensure the data's accuracy, completeness, and timeliness. The Ombudsman checks the data in the information collection form against the electronic medical record source file, notifies the researcher of any errors or discrepancies found in the form, and records the corresponding challenges based on any errors or discrepancies found to ensure that all data is recorded and reported correctly and completely. The data manager establishes electronic databases, manages data standards, and establishes and tests logical verification procedures per the research protocol requirements. After the information collection table data is incorporated into the database, the logical verification procedure checks the data validity, consistency, missing, and normal value range. The data manager should clear up the problems found in time, which can be solved by issuing data questions to researchers.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

有/Yes

注册人：

Name of Registration：

  2023-05-24 11:08:24