Data base lock

 The Database Lock Checklist Essentials for Clinical Data Managers!!!

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A successful database lock in clinical data management is essential to protect the integrity of the data and ensure that it is available for analysis and reporting & this clean DBL becomes the primary goal of every Clinical Data Manager

To enable error free DBL, "𝗗𝗕𝗟 𝗖𝗵𝗲𝗰𝗸𝗹𝗶𝘀𝘁" becomes very important go to document. Lets explore the crucial components of DBL Checklist.

💡 𝗗𝗕𝗟 𝗣𝗹𝗮𝗻𝗻𝗶𝗻𝗴 𝗠𝗲𝗲𝘁𝗶𝗻𝗴

This is a crucial step in the DBL process. During this meeting, key stakeholders come together to discuss and plan the activities and timelines leading up to the database lock.

💡 𝗗𝗕𝗟 𝗟𝗼𝗰𝗸 𝗦𝘁𝗲𝗽𝘀 𝗶𝗻 𝗴𝗶𝘃𝗲𝗻 𝗘𝗗𝗖 ( Rave / Oracle / Veeva /  Redcap etc)

Every EDC tool comes with its own unique set of steps needed to lock the database. So ensure to document clear steps towards how to perform DBL

💡 𝗗𝗮𝘁𝗮 𝗖𝗹𝗲𝗮𝗻𝗶𝗻𝗴 𝗦𝘁𝗮𝘁𝘂𝘀

Clean patient tracker (more info on CPT her https://lnkd.in/geUNnTi7) will help us track 3 crucial items (includes medical coding status, PD review status, eCRF data review etc)

i. Data Completeness and Accuracy
ii. Query Resolution
iii. Data Consistency and Quality

*Also 𝗲𝗻𝘀𝘂𝗿𝗲 𝗦𝗗𝗧𝗠 𝗱𝗮𝘁𝗮 𝘀𝗲𝘁𝘀 are thoroughly reviewed by stats and SAS programming team.

💡 𝗗𝗼𝗰𝘂𝗺𝗲𝗻𝘁𝗮𝘁𝗶𝗼𝗻

Ensuring all the study documents (including DMP, Data Validation and Cleaning Logs, Data Reconciliation Reports, DTS, DTA's, UAT documents, PPC documents, Medical coding final reports etc)  are approved and in eTMF.

💡 𝗙𝗶𝗻𝗮𝗹 𝗘𝘅𝘁𝗲𝗿𝗻𝗮𝗹 𝗗𝗮𝘁𝗮 𝗥𝗲𝗰𝗼𝗻

Final Reconciliation of external data such as lab results or imaging data, before the final database lock is critical. It ensures data quality and enhances the reliability of the trial findings.

💡 𝗦𝗮𝗳𝗲𝘁𝘆 𝗗𝗮𝘁𝗮 𝗥𝗲𝗰𝗼𝗻𝗰𝗶𝗹𝗶𝗮𝘁𝗶𝗼𝗻

The goal is to ensure the accuracy & consistency of safety information across the trial. (reviewing SAEs recorded in CRF's, safety databases, & medical records to identify discrepancies, resolve queries, and validate the completeness of safety data.)

💡 𝗨𝘀𝗲𝗿 𝗥𝗼𝗹𝗲𝘀 𝗮𝗻𝗱 𝗮𝗰𝗰𝗲𝘀𝘀

Appropriate actions need to be taken to ensure access for EDC is restricted once all data is in and cleaned

💡 𝗣𝗜 𝗦𝗶𝗴𝗻𝗮𝘁𝘂𝗿𝗲𝘀, 𝗙𝗿𝗲𝗲𝘇𝗲 & 𝗙𝗶𝗻𝗮 𝗟𝗼𝗰𝗸

Ensure all the data fields are SDV'ed, queries are closed and PI has signed of on all eCRF's then procced with Freeze and lock of data points in EDC.

💡 𝗙𝗶𝗻𝗮𝗹 𝗮𝗽𝗽𝗿𝗼𝘃𝗮𝗹𝘀 & 𝗰𝗼𝗺𝗺𝘂𝗻𝗶𝗰𝗮𝘁𝗶𝗼𝗻

Receive all the required approvals from sponsors and internal team - Lock the DBL and send out clear communications to all the stake holders

💡 𝗗𝗕 𝗨𝗻𝗹𝗼𝗰𝗸 𝘀𝘁𝗲𝗽𝘀 𝗮𝗻𝗱 𝗽𝗿𝗼𝗰𝗲𝗱𝘂𝗿𝗲𝘀

Do list all the steps in DB unlock and appropriate actions to be taken.