在读研究生/规培生参与临床试验职责及要求的调查研究

注册号:

Registration number:

ITMCTR2024000116

最近更新日期:

Date of Last Refreshed on:

2024-07-04

注册时间:

Date of Registration:

2024-07-04

注册号状态:

Registration Status:

预注册

Prospective registration

注册题目:

在读研究生/规培生参与临床试验职责及要求的调查研究

Public title:

A survey on the responsibilities and requirements of graduate students/regular trainees participating in clinical trials

注册题目简写:

English Acronym:

研究课题的正式科学名称:

医学伦理学

Scientific title:

Medical Ethic

研究课题的正式科学名称简写:

Scientific title acronym:

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:

李曼

研究负责人:

訾明杰

Applicant:

LI Man

Study leader:

ZI Mingjie

申请注册联系人电话:

Applicant telephone:

18435832332

研究负责人电话:

Study leader's telephone:

13621052996

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:

L18435832332@163.com

研究负责人电子邮件:

Study leader's E-mail:

13621052996@126.com

申请单位网址(自愿提供):

Study leader's 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:

山西省高校园区大学街121号

研究负责人通讯地址:

北京市海淀区西苑操场1号

Applicant address:

No. 121, Daxue Street, Higher Education Campus, Shanxi Province

Study leader's address:

No. 121, Daxue Street, Higher Education Campus, Shanxi 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:

山西中医药大学

Applicant's institution:

Shanxi University of Chinese Medicine

是否获伦理委员会批准:

Approved by ethic committee:

伦理委员会批件文号:

Approved No. of ethic committee:

2024XLA123-1

伦理委员会批件附件:

Approved file of Ethical Committee:

查看附件

批准本研究的伦理委员会名称:

中国中医科学院西苑医院医学伦理委员会

Name of the ethic committee:

Medical Ethics Committee of Xiyuan Hospital, China Academy of Chinese Medical Sciences

伦理委员会批准日期:

Date of approved by ethic committee:

2024/6/27 0:00:00

伦理委员会联系人:

贾敏

Contact Name of the ethic committee:

JIA min

伦理委员会联系地址:

北京市海淀区西苑操场1号

Contact Address of the ethic committee:

No.1 xiyuan caochang street, Haidian District, Beijing

伦理委员会联系人电话:

Contact phone of the ethic committee:

010-62835646

伦理委员会联系人邮箱:

Contact email of the ethic committee:

xiyuanlunli@126.com

研究实施负责(组长)单位:

中国中医科学院西苑医院

Primary sponsor:

Xiyuan Hospital of CACMS

研究实施负责(组长)单位地址:

北京市海淀区西苑操场1号

Primary sponsor's address:

No.1 xiyuan caochang street, Haidian District, Beijing

试验主办单位(项目批准或申办者):

Secondary sponsor:

经费或物资来源:

伦理委员会秘书培训、能力提升及发展模式研究

Source(s) of funding:

Research on the training, ability improvement and development model of ethics committee secretaries

研究疾病:

健康人

研究疾病代码:

Target disease:

Healthy

Target disease code:

研究类型:

Study type:

观察性研究

Observational study

研究设计:

Study design:

横断面

Cross-sectional

研究所处阶段:

Study phase:

其它

Others

研究目的:

通过调研、访谈等定性、定量相结合的方法,了解目前我院规培生及研究生参与研究的情况,对其参与研究的程度、参与研究前的授权、培训等情况深入了解,并由此评估该类人员参与研究可能面临的风险,以及学习知识能力等获益进行评估。同时,对该类人员由于缺乏相应的管理和规范的要求导致研究风险可能提高的情况,进行深入探讨,为提高临床研究质量、切实加强研究团队管理提出建议和策略。

Objectives of Study:

Through a combination of qualitative and quantitative methods such as surveys and interviews, we can understand the current participation of regular trainees and graduate students in our college in research, gain an in-depth understanding of their degree of participation in research, authorization and training before participating in research, and evaluate them accordingly. The risks that such personnel may face when participating in research, as well as the benefits such as their ability to learn knowledge, are evaluated. At the same time, we conducted an in-depth discussion on the possible increase in research risks due to the lack of corresponding management and normative requirements for this type of personnel, and put forward suggestions and strategies to improve the quality of clinical research and effectively strengthen the management of research teams.

药物成份或治疗方案详述:

Description for medicine or protocol of treatment in detail:

纳入标准:

(1)在读研究生; (2)规培生(与在读研究生可能有重合); (3)具有招生资格的导师; (4)目前带教在读研究生/规培生参与课题; (5)研究生处/规培办负责人。

Inclusion criteria

(1) Graduate students; (2) Regular trainees (may overlap with graduate students); (3) Tutors with enrollment qualifications; (4) Currently teaching graduate students/regular trainees to participate in the project; (5) The person in charge of the Graduate Studies Office/Programming and Training Office.

排除标准:

(1)在职研究生(已经工作); (2)本科实习生或者专科见习生; (3)取消招生资格的导师; (4)目前不带教在读研究生/规培生参与课题。

Exclusion criteria:

(1) On-the-job graduate students (already working); (2) Undergraduate interns or junior college trainees; (3) Tutors who have canceled their enrollment qualifications; (4) Currently, we do not teach graduate students/regular trainees to participate in the project.

研究实施时间:

Study execute time:

From 2024-07-10

To      2024-11-30

征募观察对象时间:

Recruiting time:

From 2024-07-10

To      2025-11-30

干预措施:

Interventions:

组别:

3

样本量:

120

Group:

three

Sample size:

干预措施:

-

干预措施代码:

Intervention:

-

Intervention code:

样本总量 Total sample size : 120

研究实施地点:

Countries of recruitment
and research settings:

国家:

中国

省(直辖市):

北京市

市(区县):

Country:

China

Province:

Beijing

City:

单位(医院):

中国中医科学院西苑医院

单位级别:

三级甲等

Institution/hospital:

Xiyuan Hospital of CACMS

Level of the institution:

Class IIIA

测量指标:

Outcomes:

指标中文名:

教育处或科研处管理部门访谈大纲

指标类型:

主要指标

Outcome:

Interview outline for the management department of the Education Department or Scientific Research Department

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

导师访谈大纲

指标类型:

主要指标

Outcome:

Mentor Interview Outline

Type:

Primary indicator

测量时间点:

测量方法:

Measure time point of outcome:

Measure method:

指标中文名:

研究生调查问卷

指标类型:

主要指标

Outcome:

Graduate Student Questionnaire

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:

征募研究对象情况:

尚未开始

Not yet recruiting

年龄范围:

最小 18
Min age years
最大 50
Max age years

Recruiting status:

Participant age:

性别:

Gender:

男女均可

Both

随机方法(请说明由何人用什么方法产生随机序列):

本研究不涉及随机,仅涉及抽样,对在读研究生和规培生进行抽样。

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

this abservation research just ask for the questionair, and donot use randamize,and control.

盲法:

Blinding:

是否共享原始数据:

IPD sharing:

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):

-

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

-

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:

-

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

-

数据管理委员会:

Data Managemen Committee:

Yes

研究计划书或研究结果报告发表信息
(杂志名称、期、卷、页,时间;或网址):

Publication information of the protocol/research results report
(name of the journal, volume, issue, pages, time; or website):

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