What is Data Management Plan ? What is DCF ? How is discrepancy managed ?

Question

Accepted Answer

A data management plan is a document that outlines how data will be collected, organized, stored, and shared.

A data management plan (DMP) is a formal document that describes the processes and procedures for managing data throughout its lifecycle.
It includes details on data collection, storage, organization, documentation, sharing, and preservation.
A DMP ensures that data is managed effectively, securely, and in compliance with relevant regulations and policies.
Discrepancy management refers to the process of identifying and resolving inconsistencies or differences in data.
It involves comparing data from different sources, identifying discrepancies, investigating the causes, and taking appropriate actions to rectify the discrepancies.
Discrepancies can arise due to data entry errors, system issues, or inconsistencies in data sources.
For example, if two datasets have conflicting information about a particular attribute, a data management associate would investigate the issue and work towards resolving the discrepancy.

Accepted Answer

*Study start up phase:-Crf specification , edit check specification, user acceptance testing

Study conduct phase:- data entry, Discrepancy management, Data coding, SAE reconciliation, LAB reconciliation, IRT reconciliation

Study close out phase:-freezing( soft lock), locking ( hard lock) , electronic archival, Data transfer

Data clarified form(or) query form is a specifically used in clinical trial

Dcf is primary data clarification tool from the trial sponsor (or) cro

Discrepancy management system is cleaning process in a clinical data management system. It includes manual checks and programmed check

Accepted Answer

1.DMP is document that describes the plans for collection and management of data throughout the lifecycle of a clinical trail.

DCF- data clarification form is the primary data clarification tool from the trial sponsor towards the investigator to clarify discrepancies and ask the investigator for clarification.
Discrepency management is a process of identifying and investigating and resolving of a query or a problem in the way of rasing discrepancies like ; 1 auto queries
2. manual queries

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