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Database freeze
• Temporary hold for all database change related activities,
could be performed at any point of study as and when required
also called soft lock
Database lock
• Final step towards finalization of database, also called hard
lock, required approval of PI for lock, performed by
administrator of system

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 Final Data & Queries

 Original CRFs/eCRFs
 Corrections from sites
 Calculated values for reported terms
 Data from labs
 Discrepancies
 Signed CRF
 SDV completed
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 Final QC
 Audits of the database
- Test results outside range, Pregnant Male
- Frequent data audits on data reduces DBL Period
 Summary reviews of data
- No. of records or values per patient
- Highest, lowest & mean of numeric values
- Amount of missing values
 Reconciling
- SAE & CDM cases cross check 4

- CRF & IVRS codes cross check

Process of database lock and
unlock
• Completion of all required changes, query resolution,
reconciliation, SDV, and PI signature
• Database lock checklist completion
• Database lock form filled by clinical data manager to request
for lock
• PI will provide approval
• System admin will process with Database lock
• After database lock if any change in dataset required, this will
be performed only after approval of PI on unlock form
• Unlock form must have a valid reason of database change and
details of the proposed change
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 Costs : DBL Delay
 Typical Phase III- 3 months to 1 year

 Unlocking & Relocking – 6 months

 New drugs require 3 phases

Drug patent life will expired

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 DBL : Paper Vs EDC

 EDC approximately 6-7 days after last data

generated
 Paper based – 10 weeks

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 Costs

 Assume 36000 data entry

 - 2% errors = 720 errors
 Edit checks – 80% (576 corrected)
 144 undetected

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