What is it? Why is it important?

At the final database lock, actions are taken to prevent further changes to the study database. The final lock is performed at the end of the study once:

  • All required study data has been collected and entered into the study database (eCRF)
  • Data has been checked and corrected for missing and incorrect entries
  • Data queries triggered by the study monitor have been resolved by study staff
  • The SP-INV or Site-INV has signed off the eCRF, confirming data to be correct and complete

 

After final lock:

  • Changes to the study database (eCRF) is no longer possible
  • The locked data is ready for export and statistical analysis

More

In the event of a multi-centre study, respective locks must be performed or adapted based on study progression at individual study-sites. Some sites might complete data collection earlier than others. Thus, individual site-specific locks might precede the final global lock of the study.

 

Studies with large amounts of data, or lasting over long periods of time, might profit from Interim Locks (IL). An IL will:

  • Reduce the amount of work during final lock
  • Allow for data quality checks to be performed in close proximity of the originally collected and entered data

What do I need to do?

As a SP-INV in collaboration with the study Data Manger:

  • Define well-structured procedures that must be followed during the final database lock in an SOP
  • If applicable, make special provisions based on individual site-locks versus global-lock, where all databases in all study-sites are locked
  • Inform sites ahead of time regarding final database lock in order for them to fiinalize data entry and data monitoring
  • Document time and date of database lock to prove that:
    • Statistical analysis took place after database lock
    • If applicable, blinded randomisation codes were broken after database lock

 

Plan ahead in order to avoid chaos and facilitate database lock. Hindsight management of large volumes of data carries a significant risk to data quality including the confidence in study results.

More

In order to avoid chaos and facilitate database lock, plan ahead and ensure that:

  • Study data is entered on an ongoing basis, while data is still “fresh”. The Site-INV can sign off data on an ongoing basis, so as not postpone this task to the very end
  • External data providers (e.g. laboratories) are informed regarding upcoming locks. Through ongoing data import the main study database remains current and complete, significantly reducing import workload at final lock.
  • The monitor is given adequate time for data monitoring and resolution of data queries

 

Where can I get help?

Your local CTU can support you with experienced staff regarding this topic

References

ICH-GCP E6(R2) – see in particular guidelines

  • 5.5. Trial management, data handling, and record-keeping
Abbreviations
  • CTU – Clinical Trials Unit
  • eCRF – Electronic Case Report Form
  • ICH GCP – International Council for Harmonisation - Good Clinical Practice
  • IL – Interim Lock
  • Site-INV – Site Investigator
  • SOP .Standard Operating Procedures
  • SP-INV – Sponsor Investigator
  • WI – Working Instructions
Completion ↦ Data Handling ↦ Final Database Lock ↦ Procedures
Study
Basic

Provides some background knowledge and basic definitions

Basic Protocol
Basic Statistics
Basic Monitoring
Basic Drug or Device
Concept

Starts with a study idea

Ends after having assessed and evaluated study feasibility

Concept Protocol
Concept Statistics
Concept Drug or Device
Development

Starts with confidence that the study is feasible

Ends after having received ethics and regulatory approval

Development Protocol
Development Statistics
Development Drug or Device
Set-Up

Starts with ethics and regulatory approval

Ends after successful study initiation

Set-Up Protocol
Set-Up Ethics and Laws
Set-Up Statistics
Set-Up Quality and Risk
Set-Up Drug or Device
Conduct

Starts with participant recruitment

Ends after the last participant has completed the last study visit

Conduct Protocol
Conduct Statistics
Conduct Drug or Device
Completion

Starts with last study visit completed

Ends after study publication and archiving

Completion Protocol
Completion Statistics
Completion Drug or Device
Current Path (click to copy): Completion ↦ Data Handling ↦ Final Database Lock ↦ Procedures

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