Data management plan

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DMP should be developed for each study and early during the setup of the study A data management plan or DMP is a document detailing all procedures, tasks, milestones, and deliverables throughout the CDM lifecycle. 

 It gives a roadmap on how to work with information and handle possible risks. Another important function is to clearly communicate what happens in the course of the trial to each stakeholder.

 INTRODUCTION
1.1 Purpose of the Data Management Plan (DMP) 
1.2 Scope 
2. SOPs 
3. Data management Tasks 
4. CORE/Primary project team members 
5.Communication 
5.1 Meetings 
5.2 Status Reports/Metrics 
6. clinical database used for project 
7. Training 
8. Data entry 
8.1 Audit Trail  
9. CRF Completion Guidelines 
10. Clinical Database Design and Testing 
10.1 Clinical Database Specifications 
10.2 Clinical Database Development 
10.3 User Acceptance Testing(UAT) 
11. edit checks 
11.1 System Checks 
11.2 Manual Review 
11.3 Query Prefaces 
12. Data flow 
13. Medical Coding 
14. SAE Reconciliation 
15. Data IMPORT  
15.1 Vendor Reconciliation 
16. Data Export 
17. Local Labs
17.1 Local Lab Data Entry 
17.2 Local Lab Normal Ranges 
18.Data Cuts 19. Interim Analysis 
19.1 Data Cleaning Requirements 
19.2 Post Analysis Unfreezing/Unlocking of data
20. quality control and database lock 
20.1 Database Unlock 
21. PROJECT DISPOSITION AND ARCHIVAL 


The DMP typically describes the following aspects:
 data to be gathered from trial participants, 
existing data that can be integrated(how to mix ,link, parts of data) data formats ,metadata and its standards,
 storage and backup methods,
 security measures to protect confidential information,
 data quality procedures, 
responsibility assignments across team members,
 access and sharing mechanisms and limitations,
 long-time archiving and preservation procedures, 
the cost of data preparation and archiving
and compliance with relevant regulations and requirement

Description of the data to be collected Data storage & backup. 
Data sharing & dissemination 
Data security & confidentiality
Data preservation & archiving

 The DMP must be ready at a trial design stage, before the first participant is enrolled. This will ensure that data will be collected in the correct format and properly organized. However, the plan is not something immutable: It has to be updated across the trial, capturing any changes that influence data management.

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