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CreNeuroSTM CNS Fish Oil Plus Softgels 改善轻中度抑郁症的有效性和安全性的 随机、双盲、双模拟、阳性药平行对照、多中心临床研究
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注册号：

Registration number：

 ChiCTR2600123157 

最近更新日期：

Date of Last Refreshed on：

 2026-04-22 10:38:43 

注册时间：

Date of Registration：

 2026-04-22 00:00:00 

注册号状态：

补注册

Registration Status：

Retrospective registration

注册题目：

CreNeuroSTM CNS Fish Oil Plus Softgels 改善轻中度抑郁症的有效性和安全性的 随机、双盲、双模拟、阳性药平行对照、多中心临床研究

Public title：

CreNeuroSTM CNS Fish Oil Plus Softgels A randomized, double-blind, double-dummy, parallel-controlled, multi-center clinical study on the efficacy and safety of improving mild to moderate depression with positive drugs

注册题目简写：

English Acronym：

研究课题的正式科学名称：

CreNeuroSTM CNS Fish Oil Plus Softgels 改善轻中度抑郁症的有效性和安全性的随机、双盲、双模拟、阳性药平行对照、多中心临床研究

Scientific title：

CreNeuroSTM CNS Fish Oil Plus Softgels A randomized, double-blind, double-dummy, parallel-controlled, multi-center clinical study on the efficacy and safety of improving mild to moderate depression with positive drugs

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：

曾文静 

研究负责人：

刘可智 

Applicant：

Wenjing Zeng 

Study leader：

Kezhi Liu 

申请注册联系人电话：

Applicant telephone：

 +86 28 8605 8659

研究负责人电话：

Study leader's
telephone：

+86 28 8605 8659

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：

 zengwj@creditpharma.com

研究负责人电子邮件：

Study leader's E-mail：

 kingzliu@163.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：

四川省成都市高新区科园南路88号天府生命科技园B3栋701

研究负责人通讯地址：

四川省泸州市太平街25号

Applicant address：

Room 701, Building B3, Tianfu Life Science Park, No. 88 South Keyuan Road, Gaoxin District, Chengdu City, Sichuan Province, P.R. China

Study leader's address：

No. 25, Taiping Street, Luzhou City, Sichuan 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：

四川科瑞德制药股份有限公司

Applicant's institution：

Sichuan Credit Pharmaceutical Co., Ltd.

研究负责人所在单位：

西南医科大学附属医院

Affiliation of the Leader：

Southwest Medical University Affiliated 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：

 KY2025289

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：

西南医科大学附属医院伦理委员会

Name of the ethic committee：

Ethics Committee of the Affiliated Hospital of Southwest Medical University

伦理委员会批准日期：

Date of approved by ethic committee：

 2025-05-26 00:00:00

伦理委员会联系人：

张增瑞

Contact Name of the ethic committee：

Zengrui Zhang

伦理委员会联系地址：

四川省泸州市太平街25号

Contact Address of the ethic committee：

No. 25, Taiping Street, Luzhou City, Sichuan Province

伦理委员会联系人电话：

Contact phone of the ethic committee：

 +86 830 316 5273

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：

西南医科大学附属医院

Primary sponsor：

Southwest Medical University Affiliated Hospital

研究实施负责（组长）单位地址：

四川省泸州市太平街25号

Primary sponsor's address：

No. 25, Taiping Street, Luzhou City, Sichuan 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)：

泸州市

市(区县)：

Country：

China

Province：

Luzhou City

City：

单位(医院)：

西南医科大学附属医院

具体地址：

四川省泸州市太平街25号

Institution
hospital：

Southwest Medical University Affiliated Hospital

Address：

No. 25, Taiping Street, Luzhou City, Sichuan Province

经费或物资来源：

四川科瑞德制药股份有限公司提供经费

Source(s) of funding：

Sichuan Keruidi Pharmaceutical Co., Ltd. provided the funds

研究疾病：

抑郁症  

Target disease：

Depression

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： 评价CreNeuroSTM CNS Fish Oil Plus Softgels与盐酸氟西汀胶囊治疗相比，在轻中度抑郁症患者中的有效性。 次要目的： 评价CreNeuroSTM CNS Fish Oil Plus Softgels与盐酸氟西汀胶囊治疗相比，在轻中度抑郁症患者中的安全性。  

Objectives of Study：

The primary objective of this study is to evaluate the efficacy of CreNeuroSTM CNS Fish Oil Plus Softgels compared with fluoxetine hydrochloride capsules in patients with mild to moderate depression. The secondary objective is to assess the safety profile of CreNeuroSTM CNS Fish Oil Plus Softgels versus fluoxetine hydrochloride capsules in the above-mentioned patient population.

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.既往或当前诊断为：精神分裂症、其他精神病性障碍、I型或II型双相情感障碍； 2.目前正在接受治疗或需要治疗创伤后应激障碍、急性应激障碍、恐慌障碍或强迫症的治疗的受试者； 3.伴有焦虑障碍，且HAMA评分>=21分者； 4.根据DSM-5标准，当前的初步诊断为有谵妄、边缘性、反社会型、偏执型、类分裂型、分裂型或表现性人格障碍者； 5.有抗精神病药物恶性综合征或者5-HT综合症病史者； 6.研究者判断有自杀倾向的受试者； 7.在筛查前的6个月内有药物滥用者； 8.需要使用方案禁用的药物进行治疗者； 9.曾接受过电休克治疗、经颅磁刺激或迷走神经刺激，或在当前抑郁症发作时接受过脑深部刺激； 10.在筛选前8周内进行过新发心理治疗或者心理治疗的强度有改变者； 11.目前或既往患有神经系统、心血管系统、呼吸系统、消化系统、肾脏、肝脏、血液系统、内分泌系统或其他医学疾病的，经研究者或医学监察判定会影响参加研究的受试者安全或者影响研究进行、研究结果解释的受试者，例如： 有癫痫病史者； 有严重心脏病、心肌梗死、不稳定型心绞痛、急性冠状动脉综合征或中风病史者，或有已知的个人或家族史或心源性猝死的家族史者； 目前需要抗凝治疗的房颤患者； 有哮喘病史者； 目前有未治愈的急/慢性胃溃疡、克罗恩病者； 已知肝功能不全或肾功能不全者，或筛选时实验室检查经研究者判断肝肾功能指标有临床意义者（如ALT或AST＞2倍正常上限值或肌酐超过正常值上限20%）； 促甲状腺激素（TSH）和甲状腺素（T4）的实验室检查显示有甲状腺功能减退患者。 有恶性肿瘤病史者； 12.三个月内或正在参加其他非干预性研究，或者任何干预性的研究药物、上市药物、设备的临床研究； 13.目前正在使用鱼油或 n-3 PUFAS 补充剂或叶酸或L-5甲基四氢叶酸的患者，或对鱼油、叶酸/L-5甲基四氢叶酸，或对研究食品的非膳食成分过敏者； 14.既往每周吃鱼>=3次的患者，或在过去6个月内服用鱼油或 n-3 PUFA补充剂或叶酸或L-5甲基四氢叶酸的患者； 15.妊娠者、计划妊娠者、有生育能力但不愿在试验期间及末次服药后3个月内采取有效避孕措施者；哺乳者； 16.研究者判定为有其他原因不适合参加本试验者。

Exclusion criteria：

1. Previously or currently diagnosed with: Schizophrenia, other psychotic disorders, Type I or Type II bipolar disorder; 2. Subjects currently receiving treatment or requiring treatment for post-traumatic stress disorder, acute stress disorder, panic disorder, or obsessive-compulsive disorder; 3. Those with anxiety disorders and an HAMA score of >= 21; 4. According to DSM-5 standards, currently diagnosed with delirium, borderline, antisocial, paranoid, schizotypal, schizoid, or expressive personality disorders; 5. Those with a history of antipsychotic drug toxic syndrome or 5-HT syndrome; 6. Subjects judged by the researcher to have suicidal tendencies; 7. Those who have had drug abuse within 6 months prior to screening; 8. Those who require treatment with prohibited drugs according to the protocol; 9. Those who have received electroconvulsive therapy, transcranial magnetic stimulation, or vagus nerve stimulation, or have received deep brain stimulation during the current depressive episode; 10. Those who have undergone new psychotherapy or a change in the intensity of psychotherapy within 8 weeks prior to screening; 11. Those currently or previously suffering from neurological, cardiovascular, respiratory, digestive, renal, liver, hematological, endocrine, or other medical diseases, as determined by the researcher or medical monitoring to affect the safety of the subjects participating in the study or affect the conduct of the study or interpretation of the study results, such as: Those with a history of epilepsy; Those with a history of severe heart disease, myocardial infarction, unstable angina pectoris, acute coronary syndrome or stroke, or a known personal or family history of cardiogenic sudden death; Those with atrial fibrillation who currently require anticoagulation treatment; Those with a history of asthma; Those with untreated acute/chronic gastric ulcers or Crohn's disease; Those with known liver or kidney dysfunction, or those whose laboratory test results at screening are judged by the researcher to have clinically significant indicators of liver or kidney function (such as ALT or AST > 2 times the upper limit of normal or creatinine exceeding 20% of the normal value); Those with laboratory tests showing hypothyroidism (TSH and T4); Those with a history of malignant tumors; 12. Those within 3 months or currently participating in other non-interventional studies, or any intervention-based research drugs, marketed drugs, or equipment clinical studies; 13. Those currently using fish oil or n-3 PUFAS supplements or folic acid or L-5-methyltetrahydrofolate, or allergic to fish oil, folic acid/L-5-methyltetrahydrofolate, or to the non-dietary components of the study food; 14. Those who ate fish >= 3 times per week in the past, or who have taken fish oil or n-3 PUFA supplements or folic acid or L-5-methyltetrahydrofolate in the past 6 months; 15. Those who are pregnant, planning to become pregnant, having reproductive capacity but unwilling to take effective contraceptive measures during the trial and within 3 months after the last medication intake; breastfeeding; 16. Those determined by the researcher to have other reasons that make them unsuitable to participate in this trial.

研究实施时间：

Study execute time：

从 From 2025-05-01 00:00:00至 To 2026-03-31 00:00:00  

征募观察对象时间：

Recruiting time：

从 From 2025-07-03 00:00:00 至 To 2025-09-09 00:00:00

干预措施：

Interventions：

组别：

试验组

样本量：

 40

Group：

Experimental Group

Sample size：

干预措施：

每日服用CreNeuroSTM CNS Fish Oil Plus Softgels 6粒（1粒约790mg），分为2次服用，以及盐酸氟西汀胶囊模拟剂1粒，连续服用8周。在试验过程中，受试者不允许使用除研究药物外的其他任何精神药物或接受任何行为干预治疗。

干预措施代码：

Intervention：

Take 6 capsules of CreNeuroSTM CNS Fish Oil Plus Softgels daily (approximately 790mg per capsule), divided into 2 doses. Also take 1 capsule of fluoxetine hydrochloride placebo. Continue for 8 weeks. During the trial, participants are not allowed to use any other psychotropic drugs or receive any behavioral intervention treatment except for the study drugs.

Intervention code：

组别：

对照组

样本量：

 40

Group：

Control Group

Sample size：

干预措施：

每日服用盐酸氟西汀胶囊1粒（20mg），以及CreNeuroSTM CNS Fish Oil Plus Softgels模拟剂6粒（分为2次服用），连续服用8周。在试验过程中，受试者不允许使用除研究药物外的其他任何精神药物或接受任何行为干预治疗。

干预措施代码：

Intervention：

Take 1 capsule of fluoxetine hydrochloride (20mg) daily, and 6 softgels of CreNeuroSTM CNS Fish Oil Plus Simulants (to be taken in 2 doses) continuously for 8 weeks. During the trial, the subjects are not allowed to use any other psychotropic drugs except the study drug or receive any behavioral intervention treatment.

Intervention code：

研究实施地点：

Countries of recruitment and research settings：

国家：

 中国

省(直辖市)：

 四川 

市(区县)：

  

Country：

China

Province：

Sichuan

City：

单位(医院)：

 西南医科大学附属医院 

单位级别：

 三甲 

Institution
hospital：

Affiliated Hospital of Southwest Medical University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 四川 

市(区县)：

  

Country：

China

Province：

Sichuan

City：

单位(医院)：

 四川大学华西医院 

单位级别：

 三甲 

Institution
hospital：

West China Hospital, Sichuan University

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 四川 

市(区县)：

  

Country：

China

Province：

Sichuan

City：

单位(医院)：

 成都中医药大学附属医院 

单位级别：

 三甲 

Institution
hospital：

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

Level of the institution：

Tertiary A

国家：

 中国

省(直辖市)：

 四川 

市(区县)：

  

Country：

China

Province：

Sichuan

City：

单位(医院)：

 广元市精神卫生医院 

单位级别：

 三甲 

Institution
hospital：

Guangyuan Mental Health Hospital

Level of the institution：

Tertiary Al

国家：

 中国

省(直辖市)：

 四川 

市(区县)：

  

Country：

China

Province：

Sichuan

City：

单位(医院)：

 核工业四一六医院 

单位级别：

 三甲 

Institution
hospital：

Nuclear Industry 416 Hospital

Level of the institution：

Tertiary A

测量指标：

Outcomes：

指标中文名：

双盲治疗8周后，HAMD17总分较基线的变化

指标类型：

主要指标

Outcome：

Change in total HAMD17 score from baseline after 8 weeks of double-blind treatment.

Type：

Primary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

双盲治疗2周后、4周后、6周后，HAMD17总分较基线的变化

指标类型：

次要指标

Outcome：

Changes in total HAMD17 score from baseline at 2, 4, and 6 weeks after double-blind treatment

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

双盲治疗2周后、4周后、6周后、8周后的治疗有效率（HAMD17总分较基线期下降>= 50%）

指标类型：

次要指标

Outcome：

Response rate at 2, 4, 6, and 8 weeks after double-blind treatment (>= 50% reduction in total HAMD17 score from baseline)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

双盲治疗2周后、4周后、6周后、8周后的治疗缓解率（HAMD17总分<=7分）

指标类型：

次要指标

Outcome：

Remission rate at 2, 4, 6, and 8 weeks after double-blind treatment (total HAMD17 score <= 7)

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

双盲治疗2周后、4周后、6周后、8周后，抑郁症状的临床总体印象-疾病严重程度量表(CGI-S) 评分较基线的变化

指标类型：

次要指标

Outcome：

After 2 weeks, 4 weeks, 6 weeks, and 8 weeks of double-blind treatment, the changes in the Clinical Global Impression - Severity of Illness Scale (CGI-S) scores for depressive symptoms compared to the baseline were evaluated.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

双盲治疗2周后、4周后、6周后、8周后，临床总体印象改善量表(CGI-I) 评分为1分或2分的患者比例

指标类型：

次要指标

Outcome：

Proportion of patients with a Clinical Global Impressions-Improvement (CGI-I) score of 1 or 2 at 2, 4, 6, and 8 weeks after double-blind treatment.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

双盲治疗2周后、4周后、6周后、8周后，抑郁自评量表（SDS）评分较基线的变化

指标类型：

次要指标

Outcome：

Change in Self-rating Depression Scale (SDS) scores from baseline at 2, 4, 6, and 8 weeks after double-blind treatment.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

双盲治疗8周后，生活质量评分（EQ-5D-5L）较基线的变化

指标类型：

次要指标

Outcome：

Change in quality of life score (EQ-5D-5L) from baseline after 8 weeks of double-blind treatment.

Type：

Secondary indicator

测量时间点：

测量方法：

Measure time point of outcome：

Measure method：

指标中文名：

双盲治疗4周后、8周后，汉密顿焦虑量表（HAMA）评分相较于基线的变化

指标类型：

次要指标

Outcome：

Change in Hamilton Anxiety Rating Scale (HAMA) scores from baseline at 4 and 8 weeks after double-blind treatment.

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：

结束

/Completed

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）：

试验采用区组随机方法。随机分配编码由统计学专业人员采用SAS软件在计算机上模拟产生，按照受试者区组分层。受试者将接受二组采用不同的干预措施（分别为食品试验组和阳性药对照组），分配到二组的随机概率为1:1。随机顺序表将由计算机系统自动生成，受试者将按照入组的先后顺序，由小到大依次获得指定的随机试验食品或药物编号，之后研究者将给患者与号码相对应的食品或药物。随机表具有可重现性，所设定的种子数等参数记录在随机文件中。进行了随机的受试者无论其是否使用研究食品或药物，若以任何原因终止研究，其药物编号不能分配给其他受试者再次使用。

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

A block randomization method was adopted in this trial. The random allocation codes were generated by statisticians via computer simulation using SAS software, with stratification performed according to subject blocks. Subjects were assigned to two groups with different intervention measures (the nutritional supplement experimental group and the active drug control group, respectively) at a random allocation ratio of 1:1. The random sequence table was automatically generated by a computer system. In the order of enrollment, subjects received designated random numbers corresponding to the investigational products sequentially from the smallest to the largest. Investigators then administered the investigational products matching the assigned numbers to the subjects. The randomization table was reproducible, and parameters such as the preset seed number were documented in the randomization file. For all randomized subjects, regardless of whether they took the investigational products or not, if they withdrew from the study for any reason, their assigned product numbers were not reused for other subjects.

是否公开试验完成后的统计结果:

Calculated Results after the Study Completed public access:

公开/Public

盲法：

双盲，对研究参与者和研究者设盲

Blinding：

Double-blind, with both the research participants and the researchers being blinded.

试验完成后的统计结果（上传文件）：

Calculated Results after
the Study Completed(upload file)：

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：

本次试验数据管理采用电子化数据管理系统（EDC）：数据管理的工作流程包含数据采集/管理系统建立、电子病例报告表（eCRF）及数据库的设计、数据录入、数据核查与质疑、医学编码、盲态审核、数据库锁定、解锁及再锁定、数据导出及传输、数据及数据管理文档的归档等数据管理过程。 数据管理计划：由数据管理员撰写，作为整个数据管理过程的指导性文件，数据管理所有过程均应按照其中定义的时间、内容及方法进行操作。 eCRF设计：根据方案要求设计数据采集表格，定义研究流程、数据表单名称及其收集的数据项，同时形成相应的数据完成指南，经申办者审查和批准后定稿。 数据库建立与测试：数据管理员根据研究方案建立eCRF，由数据管理员进行测试，测试内容包括：页面设计，访视期设置、访视中的录入表单顺序及每个数据点的顺序等、不同用户浏览权限的准确性等。 逻辑核查规则建立与测试：逻辑核查为数据管理员针对数据库数据的完整性、一致性和准确性而进行的核查方式，可采用系统自动逻辑核查与人工逻辑核查两种方式。数据管理人员结合EDC系统特点并根据项目实际要求进行逻辑程序的设计，数据录入同时EDC进行自动逻辑核查，实时发出系统疑问，除系统疑问外，数据管理员对系统数据进行人工核查，有问题发出人工疑问。逻辑核查测试由数据管理员根据数据核查计划完成，测试EDC系统能否按照预先设计准确执行质疑提示的触发和关闭，测试过程生成并保存有关文件存档。 医学编码：本试验不良事件采用27.0或以上版本的MedDRA字典进行编码，合并用药采用ATC分类工具进行编码分类。 系统培训：正式环境开通账号前，由数据管理员对相关人员进行培训。培训内容包括：系统操作技能培训和/或项目要求培训。具体培训内容根据人员职责及既往经验而定。所有培训应当保留培训记录 数据录入：研究人员需按照GCP和研究方案要求来收集录入受试者数据，同时依据完成指南准确、及时、完整、规范地填写eCRF。 源数据现场核查：监查员在各中心研究现场登陆EDC，核对eCRF数据与源数据的一致性，发现问题可随时在线发出疑问 疑问解答：研究者或临床协调员（CRC）对可疑数据进行澄清与解答。对于无需修改的质疑数据需填写澄清理由；对于需要修改的数据进行数据更正、必要时注明澄清理由。数据管理员或CRA等确认质疑的回复情况，必要时可驳回再次发送质疑，直至数据“清洁”。 数据盲态审核：数据管理工作完成后，数据库锁定之前，进行盲态审核。 数据锁定及导出：所有受试者完成试验，数据全部录入系统，数据清理完成后，数据管理员提出锁库申请，由主要研究者、申办者、医学人员、统计分析人员和数据管理人员等签署数据库锁定文件后，由数据管理员进行数据库锁定。锁库完成后，数据管理员将数据集交付给统计分析人员。数据库锁定之后，如果发现严重数据问题且有必要解锁数据库，主要研究者、申办者、医学人员、统计分析人员和数据管理人员等需签署解锁及重新锁库相关文件，待数据更正后重新进行数据库锁定。 eCRF存档：试验结束，生成每个受试者的eCRF电子文档，刻录光盘保存 数据管理报告：试验结束后，数据管理员根据项目实际执行的情况撰写数据管理报告。 EDC关闭：试验结束后，数据完全备份后，关闭EDC（即下线）。 容灾与备份：试验数据每日闲时自动备份在备份服务器。

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

The data management for this trial adopts an electronic data management system (EDC): The workflow of data management includes data collection / system establishment, design of electronic case report forms (eCRF) and databases, data entry, data verification and questioning, medical coding, blind review, database locking, unlocking and re-locking, data export and transmission, data and data management documentation archiving, etc. These are the data management processes. Data Management Plan: Written by the data administrator, it serves as a guiding document for the entire data management process. All processes should be carried out in accordance with the defined time, content and methods in it. eCRF Design: Design data collection forms according to the protocol requirements, define the research process, names of data forms and the data items to be collected, and form corresponding data completion guidelines. After being reviewed and approved by the sponsor, it is finalized. Database Establishment and Testing: The data administrator establishes the eCRF according to the research protocol, and the data administrator conducts the test. The test contents include: page design, visit period setting, the sequence of entry forms during visits and the sequence of each data point, the accuracy of different user browsing permissions, etc. Logical Verification Rules Establishment and Testing: Logical verification is a verification method for data administrators to check the integrity, consistency and accuracy of database data. It can be carried out using two methods: system automatic logical verification and manual logical verification. The data manager designs the logical program in combination with the characteristics of the EDC system and the actual requirements of the project. Data entry is simultaneously subject to automatic logical verification by the EDC system, and system questions are promptly raised. In addition to system questions, the data administrator manually verifies the system data and issues human questions for any problems. Logical verification testing is completed by the data administrator according to the data verification plan. The testing process generates and saves relevant files for archiving. Medical Coding: For adverse events in this trial, they are encoded using the MedDRA dictionary version 27.0 or above, and the use of combined medications is encoded using the ATC classification tool. System Training: Before opening an account in the formal environment, the data administrator conducts training for relevant personnel. The training content includes: system operation training and/or project requirements training. The specific training content is determined based on personnel responsibilities and previous experience. All training should retain training records. Data Entry: Researchers need to collect and enter the data of the subjects according to GCP and the research protocol requirements, and fill in the eCRF accurately, timely, completely and in a standardized manner according to the completion guidelines. On-site Verification of Source Data: The monitor logs into the EDC at the research site of each center to verify the consistency between the eCRF data and the source data. Any problems can be raised online at any time. Question Answering: Researchers or clinical coordinators (CRC) clarify and answer suspicious data. For data without need for modification, the reason for clarification should be filled in; for data that needs to be modified, the data should be corrected, and the reason for clarification should be noted if necessary. The data administrator or CRA, etc. confirm the reply situation of the doubts, and may reject and resend the doubts if necessary until the data is "cleaned". Blind Review: Before database locking, a blind review is conducted after the completion of data management. Data Locking and Export: After all subjects complete the trial and all data are entered into the system, and after data cleaning is completed, the data administrator submits an application to lock the database. The main researcher, sponsor, medical personnel, statistical analysts and data administrators sign the database locking file, and then the data administrator locks the database. After the database locking is completed, the data administrator delivers the data set to the statistical analysts. After the database is locked, if serious data problems are identified and it is necessary to unlock the database, the main researchers, sponsors, medical personnel, statistical analysts, and data managers need to sign the relevant documents for unlocking and re-locking the database. After the data is corrected, the database will be locked again. eCRF Archiving: At the end of the trial, an electronic eCRF document for each subject is generated and burned onto a CD for storage. Data Management Report: After the trial is completed, the data manager writes a data management report based on the actual execution of the project. EDC Shutdown: After the trial is completed, the EDC is closed (i.e., taken offline) after a complete backup of the data. Disaster Recovery and Backup: The trial data is automatically backed up to the backup server during off-peak hours every day.

数据与安全监察委员会：

Data and Safety Monitoring Committee：

无/No

注册人：

Name of Registration：

  2026-04-22 10:38:29
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