Unit 4 - Electronic data management and Database lock

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Database Lock/Unlock
• Database Lock:
Database final lock (also known as a “freeze” or “hard lock”) refers to processes used to remove access to the database
to ensure no further changes to data can be made. The final lock is a key process of database closure, but not the only
process needed to close a database properly.

• Database Unlock:
Database Unlock is opening the database for making necessary edits; ideally, a final lock should be truly final, and
subsequent unlocking is discouraged. However, certain circumstances may necessitate temporarily unlocking the
database after final lock has occurred.

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Database Lock/Unlock
➢ Once the clinical study is completed, the study database should be appropriately locked to prevent
inadvertent or unauthorized data changes prior to statistical analysis and reporting.

➢ Such procedures also ensure that in blinded studies, the blinding is not broken prematurely or by
unauthorized personnel.

➢ Locking of the database can be performed for the whole database or an agreed part of the study database
such as sites, in multicentre study.

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Database Freeze
➢ Once all CDM activities are in the final or near final stage, the database freezing activities is initiated.
➢ This is performed to initiate final Quality Control (QC) and/or independent Quality Assurance (QA)
activities for the database.
➢ Typically, database freezing is performed once
✓ all applicable data have been entered into the clinical database,
✓ all data queries and discrepancies are resolved,
✓ Serious Adverse Event (SAE) reconciliation is performed,
✓ external data have been managed, and
✓ all required CDM activities have been completed.

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Database Freeze
➢ Database freezing is performed by revoking access of all internal and external users, except LDM.
➢ Once access is revoked, the internal QC team initiate the final Quality Control checks on the study
database.
➢ If the database needs to go through independent QA checks or sponsor QA checks, the QA team to
initiate the final database audit.
➢ Read-only access to the database is provided to the QC/QA team, as applicable.
➢ If any observations are identified at the time of the QC/QA review which requires correction by the site
or by the CDM team, temporary access will be given to the required users.

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Database Lock
➢ Once the QC/QA activities are completed and an acceptable error rate has been achieved, the LDM
initiates the process of Database Lock.
➢ The LDM assigns the designated CDM personnel to coordinate with all stakeholders involved in the
study to obtain the required details for database lock.
➢ Database lock is performed by revoking the access of the LDM as well as any temporary access given to
any user.
➢ The below mentioned stakeholders will be consulted at the time of locking the database.
✓ The Clinical Operations team will be consulted to ensure that there are no outstanding activities for any of the patients at
sites that may impact the database. The Clinical Operations team will also ensure that all applicable data have been
monitored.

✓ External Data Vendors will be contacted to ensure that the final updated data have been received and there are no further
updates of the data since the last data was sent to CDM.

✓ The Biostatistician working on the study will be consulted to ensure that the required statistical checks of the data have
been completed and any identified data anomaly has been corrected. Confirmation of the finalisation of the Statistical
Analysis Plan (SAP) will also be obtained.
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Database Lock
➢ The LDM will ensure that all activities have been completed and there are no outstanding issues before
the database is locked.
➢ Once the above items are checked, the designated CDM personnel will complete the Database Lock
Form and will submit it to the LDM for approval.
➢ Once the LDM has approved the Database Lock Form, it will be sent to the Clinical Operations team, the
Biostatistician and the Client/Sponsor representative for their signature.
➢ The designated personnel from CDM will lock the database once signatures from all stakeholders are
obtained and document the database lock date in the Database Lock Form.
➢ The fully completed Database Lock Form will be circulated to all stakeholders for their records and
notification of database lock.

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Database Lock Form- Sample

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Database Lock Form - Sample

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Database Unlock and Relock
➢ Occasionally it may be necessary to correct previously missed data errors or inconsistencies after
database lock.
➢ A database will only be unlocked if the data to be changed would have a significant impact on the
statistical outcome of the analysis.
➢ Once the error is identified in the locked database, the LDM will conduct a meeting with all applicable
stakeholders involved in the study including the Sponsor.
➢ It will then be mutually agreed whether the database should be unlocked or if the error can be
corrected without unlocking the database.
➢ In case it is decided that the database should be unlocked, the designated personnel from CDM will
complete the Database Unlock and Relock Form and submit it to the LDM for signature.
➢ The LDM will approve the database unlock by signing the form and then the form will be sent to the
Client for approval signature.

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Database Unlock and Relock
➢ Once approval for unlocking is obtained, the designated personnel from CDM will unlock the database
and document the date of the database unlock on the Database Unlock and Relock Form.
➢ The required correction or changes will be performed in the database and then the database will be
relocked.
➢ While relocking the database, the approval from the LDM and the client will be obtained.
➢ The fully completed Database Unlock and Relock Form will be sent to the Client for their records and all
stakeholders will be informed about the database unlock and relock.

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Database Unlock and Relock - Sample

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Database Interim Lock
➢ In some studies, interim database lock will be performed to take the snapshot of available data at a
particular point in time to facilitate statistical analysis and data review before study completion.
➢ In studies where interim database lock is required, the procedure will be mentioned in the study
specific Data Management Plan (DMP) and the interim lock will be performed accordingly.

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Post Database Lock Procedures
➢ Once the database is locked, the LDM will perform the following activities:
✓ Data Management Report will be prepared, details of database lock will be explained, and the
documentation of database lock will be included.

✓ Audit trail report per site, query report and CRF data is provided to each site via secured transfer
mechanism for the record of patient data recruited at each site.

✓ Final datasets is exported and sent to the Biostatistician or appropriate Client contact.

✓ Final data back-up is taken and in the study drive for future reference and for the purposes of audit
or inspection.

✓ Electronic documents generated during the study is archived.

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Electronic Data Interchange (EDI)
➢ EDI or Electronic Data Interchange is the virtual exchange of data in electronic format

➢ This exchange of data is generally between two systems and consists of transferring subject data

➢ By nature, eliminates paper trails, improves operational efficiency and enhances virtual exchanges with

new trading partners.

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Electronic Data Interchange (EDI)
Manual Process EDI Process

Specify Data Requirement

Subject Data Emailed/Faxed Manually Reconciled Subject Data

Main database Study tool database

Merge with main Manually Reviewed &

database Email to main database Qced

Example : electronic subject diary

Example : Subject Diary manually maintained
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Electronic Data Interchange (EDI)
Advantage of EDI
➢ Lower operating costs
➢ Improve data transfer process and speeds
➢ Reduce human error in data transfer and improve record accuracy
➢ Paperless and environmentally friendly

Disadvantage of EDI
➢ Perceived high upfront costs
➢ Initial setup is time consuming
➢ Investing in system protection
➢ Require robust data backups of systems

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Thank You!!!

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