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审核状态: Project audit state: |
通过审核 Successful |
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注册号: Registration number: |
ChiCTR2400084405 |
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最近更新日期: Date of Last Refreshed on: |
2024-05-16 09:36:18 |
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注册时间: Date of Registration: |
2024-05-16 00:00:00 |
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注册号状态: |
预注册 |
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Registration Status: |
Prospective registration |
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注册题目: |
基于诊室血压与家庭血压管理对高血压病人心血管疾病转归影响研究 |
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Public title: |
Effect of home blood pressure and office blood pressure target value monitoring on the outcome of cardiovascular disease in hypertensive patients |
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注册题目简写: |
HAO-Target研究 |
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English Acronym: |
The HAO-Target Study |
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研究课题的正式科学名称: |
基于诊室血压与家庭血压管理对高血压病人心血管疾病转归影响研究 |
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Scientific title: |
Effect of home blood pressure and office blood pressure target value monitoring on the outcome of cardiovascular disease in hypertensive patients |
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研究课题代号(代码): Study subject ID: |
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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: |
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申请注册联系人: |
刘渔凯 |
研究负责人: |
曾春雨 |
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Applicant: |
Liu yukai |
Study leader: |
Zeng Chunyu |
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申请注册联系人电话: Applicant telephone: |
+86 139 8346 2076 |
研究负责人电话: Study leader's telephone: |
+86 139 8362 4369 |
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申请注册联系人传真 : Applicant Fax: |
研究负责人传真: Study leader's fax: |
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申请注册联系人电子邮件: Applicant E-mail: |
liuyukai12345678@163.com |
研究负责人电子邮件: Study leader's E-mail: |
chunyuzeng01@163.com |
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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): |
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申请注册联系人通讯地址: |
重庆市渝中区大坪长江之路10号 |
研究负责人通讯地址: |
重庆市渝中区大坪长江之路10号 |
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Applicant address: |
10 Changjiang Access Rd, Yuzhong district, Chongqing |
Study leader's address: |
10 Changjiang Access Rd, Yuzhong district, Chongqing |
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申请注册联系人邮政编码: Applicant postcode: |
400042 |
研究负责人邮政编码: Study leader's postcode: |
400042 |
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申请人所在单位: |
陆军特色医学中心 |
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Applicant's institution: |
Army Medical Center of PLA |
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研究负责人所在单位: |
陆军特色医学中心 |
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Affiliation of the Leader: |
Army Medical Center of PLA |
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是否获伦理委员会批准: |
是/Yes |
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Approved by ethic committee: |
Yes |
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伦理委员会批件文号: Approved No. of ethic committee: |
医研部伦审(2024)第27号 |
伦理委员会批件附件: Approved file of Ethical Committee: |
查看附件View |
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批准本研究的伦理委员会名称: |
中国人民解放军陆军特色医学中心伦理委员会 |
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Name of the ethic committee: |
Ethics Committee of Army Medical Center of PLA |
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伦理委员会批准日期: Date of approved by ethic committee: |
2024-01-31 00:00:00 |
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伦理委员会联系人: |
王晶晶 |
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Contact Name of the ethic committee: |
Wang Jingjing |
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伦理委员会联系地址: |
重庆市渝中区大坪长江支路10号 |
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Contact Address of the ethic committee: |
10th Changjiang Road, Yuzhong District, Chongqing, China |
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伦理委员会联系人电话: Contact phone of the ethic committee: |
+86 23 6875 7140 |
伦理委员会联系人邮箱: Contact email of the ethic committee: |
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研究实施负责(组长)单位: |
陆军特色医学中心 |
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Primary sponsor: |
Army Medical Center of PLA |
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研究实施负责(组长)单位地址: |
重庆市渝中区大坪长江支路10号 |
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Primary sponsor's address: |
10th Changjiang Branch Road, Yuzhong District, Chongqing, China |
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试验主办单位(项目批准或申办者): Secondary sponsor: |
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经费或物资来源: |
云南省科技厅重大科技专项项目 |
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Source(s) of funding: |
Science and Technology Major Project of Yunnan Provincial Science and Technology Department |
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Target disease: |
hypertension |
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Target disease code: |
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研究类型: |
干预性研究 |
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Study type: |
Interventional study |
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研究所处阶段: |
其它 | ||||||||||||||||||||||
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Study phase: |
N/A |
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研究设计: |
随机平行对照 |
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Study design: |
Parallel |
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研究目的: |
通过在全国范围内开展多中心、前瞻性、随机、开放标签对照研究,明确高血压人群以诊室血压监测/家庭血压监测进行降血压治疗对于预后的影响,为国内外高血压指南更新提供临床证据支撑。 |
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Objectives of Study: |
By conducting multicenter, prospective, randomized, open-label controlled studies nationwide, the effect of lowering blood pressure via clinic blood pressure monitoring/home blood pressure monitoring on prognosis in the population with hypertension are clarified. This provides clinical evidence support for the update of hypertension guidelines at home and abroad. |
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药物成份或治疗方案详述: |
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Description for medicine or protocol of treatment in detail: |
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纳入标准: |
1.年龄大于50岁且小于等于79岁; 2.未服药情况下非同日3次诊室测量收缩压在140~180mmHg或正在进行降压治疗的高血压患者; 3.至少满足以下一项心血管高危因素: 1) 存在临床或亚临床心脑血管疾病;(临床心血管疾病包括但不限于: a) 既往(大于6个月)心肌梗死(MI)、脑卒中(包括缺血型卒中及出血性卒中,但不包括腔隙性脑梗死及TIA)、经皮冠状动脉介入术(PCI)、冠状动脉旁路移植术(CABG)、颈动脉内膜切除术(CE)、颈动脉支架植入术;b) 既往(大于6个月)外周动脉疾病(PAD)并进行血管重建;c) 既往(大于6个月)急性冠状动脉综合征,伴或不伴静息心电图变化、心电图运动试验中心电图变化或阳性心脏影像学研究;d) 冠状动脉、颈动脉或下肢动脉直径狭窄至少50%;e) 腹主动脉瘤(AAA)≥5厘米,无论是否性手术治疗。亚临床疾病包括:a) 过去2年内冠状动脉钙化评分(Agatston units)≥400;b) 过去2年内踝臂指数(ABI)≤0.90;c) 过去2年内心电图、超声心动图报告或其他心脏影像学检查报告显示左室肥厚(LVH)。) 2) 慢性肾脏病(CKD),根据过去6个月内最新的实验室检查,eGFR值为30-59 ml/min/1.73m2。eGFR根据MDRD方程进行计算,EGFR(ml/min/1.73m2)= 186 × (Scr)^-1.154 × (年龄)^-0.203 × (0.742女性) × 1.233 (J Am Soc Nephrol. 2006;17:2937-44) 3) 合并有2型糖尿病,随访检测空腹血糖大于或等于7.0mmol/L和/或糖化血红蛋白(≥6.5%)作为诊断糖尿病的标准。 4) 根据最近12个月的血脂实验室检查结果,10年心血管疾病风险的China-PAR风险评估模型≥10%。 5) 年龄≥70岁。 4.已获得并签署知情同意书。 |
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Inclusion criteria |
1.Age is greater than 50 years old and less than or equal to 79 years old; 2.In the absence of medication, systolic blood pressure measured in the clinic on three different days is between 140-180mmHg, or patients with hypertension who are currently undergoing antihypertensive treatment; 3.At least one high-risk cardiovascular factor is met: 1)Clinical or subclinical cardiovascular and cerebrovascular diseases exist; (Clinical cardiovascular diseases include, but are not limited to: a) Previous (greater than 6 months) myocardial infarction (MI), stroke (including ischemic stroke and hemorrhagic stroke, excluding lacunar infarction and TIA), percutaneous coronary intervention (PCI), coronary artery bypass grafting (CABG), carotid endarterectomy (CE), carotid stent implantation; b) Previous (greater than 6 months) peripheral arterial disease (PAD) with revascularization; c) Previous (greater than 6 months) acute coronary syndrome, with or without resting ECG changes, ECG changes during exercise testing, or positive cardiac imaging studies; d) Coronary artery, carotid artery, or lower limb artery with at least 50% diameter stenosis; e) Abdominal aortic aneurysm (AAA) ≥5 cm, regardless of whether surgical treatment is performed. Subclinical diseases include: a) Coronary artery calcium scoring (Agatston units) ≥400 within the past 2 years; b) Ankle-brachial index (ABI) ≤0.90 within the past 2 years; c) ECG, echocardiography, or other cardiac imaging reports showing left ventricular hypertrophy (LVH) within the past 2 years.) 2)Chronic kidney disease (CKD), with an eGFR value of 30-59 ml/min/1.73m2 based on the most recent laboratory test within the past 6 months. The eGFR is calculated according to the MDRD equation: eGFR (ml/min/1.73m2) = 186 × (Scr)^-1.154 × (Age)^-0.203 × (0.742 if female) × 1.233 (J Am Soc Nephrol. 2006;17:2937-44). 3)Comorbid with type 2 diabetes, with fasting blood glucose greater than or equal to 7.0mmol/L and/or glycated hemoglobin (≥6.5%) as the diagnostic criteria for diabetes. 4)According to the results of the most recent lipid laboratory test within the past 12 months, the 10-year cardiovascular disease risk assessed by the China-PAR risk assessment model is ≥10%. 5)Age is ≥70 years old. 4.An informed consent form has been obtained and signed. |
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排除标准: |
(1)SBP≥180mmHg和或 DBP<60mmHg; (2)诊室血压大于140/90 mmHg,而家庭血压小于135/85 mmHg; (3) 存在继发性高血压(既往确诊患有继发性高血压且未明确治愈者,如怀疑患有继发性高血压,需完善检查排除常见的继发性高血压,包括肾性高血压[肾实质病变、肾动脉狭窄]、原发性醛固酮增多症、库欣综合征、嗜铬细胞瘤、主动脉缩窄等); (4)大量蛋白尿(24小时尿蛋白排泄量≥1克/天,或24小时尿白蛋白排泄量≥600毫克/天,随机尿蛋白/肌酐比值≥1克/克肌酐,或随机尿白蛋白/肌酐比值≥600毫克/克肌酐,或尿常规尿蛋白≥2+。 (5)上臂的臂围过大或过小,而不能用血压计准确测量血压者(如上臂臂围大于32cm)。 (6)在近3个月来因不稳定型心绞痛住院。 (7)过去6个月内出现的急性心肌梗死或急性脑卒中; (8)任何器官移植者 (9)近6月不明原因体重减轻超过10% (10)怀孕或备孕 (11) 扩心病、肥厚型心肌病、风心病、先天性心脏病、严重心脏瓣膜病(重度瓣膜狭窄和或返流); (12)合并严重身体疾病且预期生存时间<12月(比如恶性肿瘤); (13) 严重肝或肾功能障碍(ALT和或AST)≥正常值上限的3倍,或透析终末期肾病或eGFR<30ml/min/1.73m2,或血清肌酐>2.5mg/dL[>221μmol/L]); (14)过去6个月内出现症状性心力衰竭或左心室射血分数降低(<40%); (15) 过去有明确心房颤动病史; (16)既往降压治疗在SBP≤130mmHg(诊室血压)出现低血压事件或因降压至SBP≤130mmHg(诊室血压)引起的头晕、乏力等症状且不能耐受继续降压治疗。 (17)对研究药物或对其成分服用后有过敏史者; (18)正在参加其他临床研究者; (19)患有残疾、活动障碍、智力障碍等因素,可能导致无法正常参与研究和进行随访者(必要时通过FRAIL衰弱筛查量表评估衰弱情况、通过MMSE量表评估智能精神状态); (20)存在以下可能影响患者依从性的情况,或研究人员认为存在其他原因不适合临床试验者。 (a) 在过去12个月内有酒精或药物滥用史 (b) 计划在2年内(近期)搬离随访点而无法转到另一个HAO-Target随访点 (c) 既往有明显不遵医嘱用药或随访的病人 (d) 来自配偶、重要他人或家庭成员对参与研究的重大担忧 (e) 临床诊断痴呆,并接受治疗痴呆的药物,或者按照研究人员的判断认为受试者认知上无法遵循试验流程进行试验。 (21)临床诊断精神高度焦虑患者。 |
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Exclusion criteria: |
(1) SBP is ≥180mmHg and/or DBP is <60mmHg; (2) Office blood pressure is greater than 140/90 mmHg, while home blood pressure is less than 135/85 mmHg; (3) Diagnosis of secondary hypertension (previously diagnosed with secondary hypertension and not definitely cured, if suspected to have secondary hypertension, complete examination is needed to rule out common secondary hypertension, including renal hypertension [renal parenchymal disease, renal artery stenosis], primary aldosteronism, Cushing's syndrome, pheochromocytoma, aortic coarctation, etc.); (4) Massive proteinuria (24-hour urinary protein excretion ≥1 gram/day, or 24-hour urinary albumin excretion ≥600 milligrams/day, random urine protein/creatinine ratio ≥1 gram/gram creatinine, or random urine albumin/creatinine ratio ≥600 milligrams/gram creatinine, or urinary routine protein ≥2+. (5) The circumference of the upper arm is too large or too small, making it impossible to accurately measure blood pressure with a sphygmomanometer (such as upper arm circumference greater than 32cm). (6) Hospitalized for unstable angina within the past 3 months. (7) Acute myocardial infarction or acute stroke that occurred within the past 6 months; (8) Any organ transplant recipient. (9) Unexplained weight loss of more than 10% within the past 6 months. (10) Pregnant or planning to become pregnant. (11) Dilated cardiomyopathy, hypertrophic cardiomyopathy, rheumatic heart disease, congenital heart disease, severe valvular heart disease (severe valve stenosis and/or regurgitation); (12) Complicated by severe illness with a life expectancy of less than 12 months (such as malignant tumors); (13) Severe liver or renal dysfunction (ALT and/or AST) ≥ three times the upper limit of normal, or end-stage renal disease on dialysis, or eGFR <30ml/min/1.73m2, or serum creatinine >2.5mg/dL [>221μmol/L]; (14) Symptomatic heart failure or reduced left ventricular ejection fraction (<40%) within the past 6 months; (15) History of atrial fibrillation; (16) Hypotensive events or symptoms such as dizziness and fatigue caused by blood pressure reduction to SBP ≤130mmHg (office blood pressure) during previous antihypertensive treatment, and cannot tolerate continued blood pressure reduction treatment. (17) History of allergy to medication or its components in the study; (18) Currently participating in other clinical studies; (19) Patients with disabilities, mobility impairments, intellectual disabilities, and other factors that may prevent normal participation in the study and follow-up (if necessary, assess frailty using the FRAIL scale, and assess cognitive mental state using the MMSE scale); (20) There are situations that may affect patient compliance, or the researcher believes there are other reasons that are not suitable for clinical trials. (a) History of alcohol or drug abuse within the past 12 months. (b) Planning to move away from the follow-up site within 2 years (short term) and unable to transfer to another HAO-Target follow-up site. (c) Patients with a history of not complying with medical advice or follow-up. (d) Significant concerns from the spouse, significant other, or family member about participating in the study. (e) Clinical diagnosis of dementia, and receiving medication for dementia, or the researcher judges that the subject is cognitively unable to follow the trial process. (21) Clinically diagnosed patients with high anxiety. |
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研究实施时间: Study execute time: |
从 From 2024-01-01 00:00:00至 To 2029-12-31 00:00:00 |
征募观察对象时间: Recruiting time: |
从From 2024-05-20 00:00:00 至 To 2029-05-20 00:00:00 |
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干预措施: Interventions: |
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研究实施地点: Countries of recruitment and research settings: |
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测量指标: Outcomes: |
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采集人体标本:
Collecting sample(s)
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征募研究对象情况: Recruiting status: |
正在进行 Recruiting |
年龄范围: Participant age: |
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性别: |
男女均可 |
Gender: |
Both |
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随机方法(请说明由何人用什么方法产生随机序列): |
本研究为随机开放式研究,通过设计的随机软件进行中心系统性随机。所有受试者入选后向大坪中心申请编号,大坪中心将所有受试者按阿拉伯数字从1到大进行编号记录。受试者按1∶1的比例随机分配到家庭血压组和诊室血压组中,使受试者被分配到任何一个组的几率相等。 |
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Randomization Procedure (please state who generates the random number sequence and by what method): |
This study is a randomized open-label study, in which central systemic randomization is performed using designed randomization software. After all subjects are selected, an application for numbering is made to the Daping Center. The Daping Center will number all subjects sequentially in Arabic numerals from 1 up to the total number. Subjects are randomly assigned to the home blood pressure group and the office blood pressure group in a 1:1 ratio, ensuring that the probability of being assigned to either group is equal for each participant. |
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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 |
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盲法: |
无 |
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Blinding: |
None |
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试验完成后的统计结果(上传文件): |
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Calculated Results after
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是否共享原始数据: IPD sharing |
Yes |
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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): |
项目组根据研究进程择期选择具体方式公开原始数据 |
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The way of sharing IPD”(include metadata and protocol, If use web-based public database, please provide the url): |
According to the progress of the research, raw research data should be made freely available to all researchers in specific ways. |
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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: |
受试者的筛选和随访由各分中心专人负责,分中心负责筛选阶段和不良事件报告的电子 CRF 表的填写;随访阶段分中心负责即时上传随访证据(视频及照片),由组长单位委托数据和安全监测委员会组织人员根据随访证据填写电子版CRF 表,分中心定期接受质控小组的检查。最后所有随访电子 CRF 表由组长单位负责统一长期保存。 |
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Data collection and Management (A standard data collection and management system include a CRF and an electronic data capture: |
The screening and follow-up of subjects are the responsibility of a designated person at each sub-center. The sub-center is responsible for filling out the electronic Case Report Form (CRF) during the screening phase and for reporting adverse events. During the follow-up phase, the sub-center is responsible for uploading follow-up evidence (videos and photos) in real time, and the principal unit commissions the Data and Safety Monitoring Committee to organize personnel to fill out the electronic CRF based on the follow-up evidence. The sub-center regularly undergoes inspections by the quality control team. Finally, all follow-up electronic CRFs are uniformly preserved for the long term by the principal unit. |
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数据与安全监察委员会: Data and Safety Monitoring Committee: |
有/Yes |