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DTA(Data transfer agreement)

 Basics of Clinical Data Transfer Agreements (CDTA's / DTA's) for Clinical Data Managers

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A clinical data transfer agreement (CDTA) or commonly called as Data transfer agreement (DTA) is one of the important auditable document that is managed by clinical data manager
 
Ideally DTA's should be finalized before the study go live ( in study start-up phase) and data need to be reconciled as per the DTA in conduct phase.
 
DM's use DTA's normally in 2 scenarios
 
1. When we are receiving external data from third party vendors (Ex - lab data)
2. When we are transferring data to sponsor's or other labs or to other CRO's
 
The purpose of a CDTA / DTA is to protect the confidentiality, integrity, and security of the data being transferred.
 
Typical CDTA / DTA includes below items.
 
1. The parties involved in the data transfer & their contact details
2. The purpose of the data transfer 
3. The types & formats of the data being transferred
4. Details of Data variables being transferred
5. Data transfer location & Access to team members
6. Number of data Transfers ( During Milestone, these numbers will increase)
7. Details about Blinded /unblinded data - This is critical
8. The frequency of the data transfer
9. The responsibilities of the parties involved in the data transfer
10. Data checks & reconciliation steps to be performed on the data
11. Process to resolve the data issues, track Data correction forms (DCF's) etc
 
As a clinical data manager, here are the few steps you can take to effectively handle Data transfer agreements (DTA's) in the study.
 
Review the DTA thoroughly: Carefully review the DTA to ensure that you understand the purpose of the data transfer, the types of data being transferred, frequency etc.
 
1. Clarify any questions or concerns: If you have any questions or concerns about the DTA, it is important to raise them with the other party before signing. This will help to ensure that both parties are in agreement about the terms of the data transfer.
 
2. Monitor the data transfer: It is important to closely monitor the data transfer to ensure that it is being carried out in accordance with the DTA. This may involve reviewing reports & checking data quality.
 
3. Resolve any issues: If any issues arise during the data transfer, it is important to work with the other party to resolve them in a timely and effective manner. Also if you find data issues during the reconciliation, then ensure to communicate & resolve effectively.

Data transfer agreement contents

Purpose

       Type of data

         File naming conventions

         Data transfer mode 

         Data transfer type

         Frequency/Transfer frequency /schedule

  • Vendor agreements

  • Company agreements





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