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  #2  
24th July 2014, 01:46 PM
Super Moderator
 
Join Date: Apr 2013
Re: Clinical Data Management Quality Assurance

Quality Assurance in Clinical Data Management is a paper represented for discusses the organization, procedures, and technical methods used by Quality Assurance unit to certify data processing quality and data integrity . Clinical data management is involved in ensuring data quality and integrity is issued through the final statistical analysis of the resultant data.

It involves :-
1.Careful consideration of the clinical forms and schedule of patient visits;

2.Feedback to clinical monitors of systematic errors by investigators;

3.Feedback to data processing on data entry errors, etc.

Quality assurance unit dedicatedly work for data quality assurance and integrity. The purpose of this unit is to:

1. Identify data processing errors, correct such errors, and provide feedback after completion of a study.

2. Identify and document the protocol violations, missing or unprocessed documents,
3. Identifies special situations regarding a patient that a biostatistician needs to know.
4. Report any special data processing situations

Clinical Data Management Quality Assurance







  #3  
21st February 2015, 04:59 PM
Unregistered
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Clinical Data Management Quality Assurance

I want to get details of Clinical Data Management Quality Assurance of Massachusetts Biotechnology Council so will you please provide me that ?
  #4  
22nd February 2015, 09:37 AM
Super Moderator
 
Join Date: Apr 2013
Re: Clinical Data Management Quality Assurance

As you want to get details of Clinical Data Management Quality Assurance of Massachusetts Biotechnology Council so here I am giving you same:

Organization of this course:
Organizational Chart
Number of facilities
Who, What ,Where
Number of employees, FTE
Departmental Structures
Turn over rates
Average length of employment

Facilities of this course:
Adequate to support functions
Work Flow
Adequate security
Adequately protected
Adequate back-up of data

Systems of this course:
Quality Function
Standard Operating Procedures
Work Instructions
Employees
Job Descriptions
CVs
Training
Standard Operating Procedures
Work Instructions
Employees
Job Descriptions
CVs
Training

For detailed information of this course here is the attachment:
Attached Files
File Type: zip Clinical-Data-Management-Quality-Assurance.zip (30.5 KB, 29 views)


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