Assuring Good Laboratory Practices - An Audit of Knowledge and Practices of Online QC Monitoring using Bio-Rad Unity Real Time Software (URT) by Medical Technologists at the Section of Chemical Pathology

注册号:

Registration number:

ChiCTR2100042949 

最近更新日期:

Date of Last Refreshed on:

2021-05-16 12:23:59 

注册时间:

Date of Registration:

2021-02-01 00:00:00 

注册号状态:

补注册

Registration Status:

Retrospective registration

注册题目:

Assuring Good Laboratory Practices - An Audit of Knowledge and Practices of Online QC Monitoring using Bio-Rad Unity Real Time Software (URT) by Medical Technologists at the Section of Chemical Pathology

Public title:

Assuring Good Laboratory Practices - An Audit of Knowledge and Practices of Online QC Monitoring using Bio-Rad Unity Real Time Software (URT) by Medical Technologists at the Section of Chemical Pathology

注册题目简写:

English Acronym:

研究课题的正式科学名称:

Assuring Good Laboratory Practices - An Audit of Knowledge and Practices of Online QC Monitoring using Bio-Rad Unity Real Time Software (URT) by Medical Technologists at the Section of Chemical Pathology

Scientific title:

Assuring Good Laboratory Practices - An Audit of Knowledge and Practices of Online QC Monitoring using Bio-Rad Unity Real Time Software (URT) by Medical Technologists at the Section of Chemical Pathology

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:

Dr Sibtain Ahmed 

研究负责人:

Dr Sibtain Ahmed 

Applicant:

Dr Sibtain Ahmed 

Study leader:

Dr Sibtain Ahmed 

申请注册联系人电话:

Applicant telephone:

+92 21 34861927

研究负责人电话:

Study leader's
telephone:

+92 21 34861927

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:

sibtain.ahmed@aku.edu

研究负责人电子邮件:

Study leader's E-mail:

sibtain.ahmed@aku.edu

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:

Sopari Wala Building, Aga Khan Hospital, Stadium Road

研究负责人通讯地址:

Opari Wala Building, Aga Khan Hospital, Stadium Road

Applicant address:

Sopari Wala Building, Aga Khan Hospital, Stadium Road

Study leader's address:

Opari Wala Building, Aga Khan Hospital, Stadium Road

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:

巴基斯坦卡拉奇Aga Khan University

Applicant's institution:

Aga Khan University

研究负责人所在单位:

巴基斯坦卡拉奇Aga Khan University

Affiliation of the Leader:

Aga Khan University

是否获伦理委员会批准:

Approved by ethic committee:

Yes

伦理委员会批件文号:

Approved No. of ethic committee:

CA-01/2020

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:

Department of Pathology Quality Management Committee, Aga Khan Hospital

Name of the ethic committee:

Department of Pathology Quality Management Committee, Aga Khan Hospital

伦理委员会批准日期:

Date of approved by ethic committee:

2020-04-01 00:00:00

伦理委员会联系人:

Dr Lena Jafri (Section Head Chemical Pathology)

Contact Name of the ethic committee:

Dr Lena Jafri (Section Head Chemical Pathology)

伦理委员会联系地址:

Sopari wala building, Aga Khan University Karachi Pakistan

Contact Address of the ethic committee:

Sopari wala building, Aga Khan University Karachi Pakistan

伦理委员会联系人电话:

Contact phone of the ethic committee:

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:

巴基斯坦卡拉奇Aga Khan University

Primary sponsor:

Aga Khan University, Karachi

研究实施负责(组长)单位地址:

巴基斯坦卡拉奇Aga Khan University

Primary sponsor's address:

Aga Khan University, Karachi

试验主办单位(项目批准或申办者):

Secondary sponsor:

国家:

巴基斯坦

省(直辖市):

信德

市(区县):

卡拉奇

Country:

Pakistan

Province:

Sindh

City:

Karachi

单位(医院):

Aga Khan University

具体地址:

Stadium Road Karachi

Institution
hospital:

Aga Khan University

Address:

Stadium Road Karachi

经费或物资来源:

None

Source(s) of funding:

None

研究疾病:

Assessment of knowledge of technologists  

Target disease:

Assessment of knowledge of technologists

研究疾病代码:

Target disease code:

研究类型:

观察性研究

Study type:

Observational study

研究所处阶段:

其它 

Study phase:

N/A

研究设计:

连续入组 

Study design:

Sequential 

研究目的:

To do a Virtual Assessment, Training and Evaluation Course of Clinical Laboratory Technologists Amidst Peak COVID-19 Pandemic.  

Objectives of Study:

To do a Virtual Assessment, Training and Evaluation Course of Clinical Laboratory Technologists Amidst Peak COVID-19 Pandemic.

药物成份或治疗方案详述:

Chemical Pathology Laboratory Technologists serving the section. 

Description for medicine or protocol of treatment in detail:

 

纳入标准:

Inclusion criteria

排除标准:

Non-technical staff.

Exclusion criteria:

Non-technical staff.

研究实施时间:

Study execute time:

From 2020-04-01 00:00:00 To 2020-10-31 00:00:00  

征募观察对象时间:

Recruiting time:

From 2020-04-01 00:00:00 To 2020-10-31 00:00:00

干预措施:

Interventions:

组别:

case series

样本量:

20

Group:

Case series

Sample size:

干预措施:

N/A

干预措施代码:

Intervention:

Not Applicable

Intervention code:

研究实施地点:

Countries of recruitment and research settings:

国家:

巴基斯坦

省(直辖市):

信德 

市(区县):

卡拉奇 

Country:

Pakistan

Province:

Sindh

City:

Karachi

单位(医院):

Aga Khan University 

单位级别:

三级 

Institution
hospital:

Aga Khan University

Level of the institution:

Tertiary

测量指标:

Outcomes:

指标中文名:

Score

指标类型:

主要指标

Outcome:

Score

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:

Recruiting status:

结束

/Completed

年龄范围:

Participant age:

最小 Min age 18 years
最大 Max age 60 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):

The study participants comprised of the three tiers of clinical scientists working in the laboratory ranging from the senior-most cadre of charge technologists, senior technologists and, technologists. The study leader performed the randomization with equal gender distribution.

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

The study participants comprised of the three tiers of clinical scientists working in the laboratory ranging from the senior-most cadre of charge technologists, senior technologists and, technologists. The study leader performed the randomization with equal gender distribution.

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:

Blinding:

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):

article publication in indexed journal

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

article publication in indexed journal

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:

via password protected Google Docs

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

via password protected Google Docs

数据与安全监察委员会:

Data and Safety Monitoring Committee:

有/Yes

注册人:

Name of Registration:

 2021-02-01 11:37:30