Clinical Submission Global Integrated Database (GIDB)

With respect to the final QC controlled and QA clinical submission GIDB and "locking the database" - is a "Database Lock Form" required?

The answer is - yes. Remember, at the clinical study level, when a database is locked, a "Database Lock Form" is required. The same holds true at the submission level with the GIDB Lock.

The Database Lock Form will include:

• Sponsor name
• Project name - usually the name of the investigational drug
• Database - GIDB - Global Integrated Database
• Version
• Statement - "After checking all items relative to the data management activities, the clinical manager and the data manager (pharma, CRO, consultant or otherwise, in-house or outsourced) indicate that the database is final and request it to be locked."
• Signed and dated by the clinical manager
• Signed and dated by the data manager
• Signed and dated by the biostatistician that wrote the SAP (GIDB) - the person performing the "Lock"
• Time and date of the GIDB Lock.

There are no changes allowed to the GIDB after the time, date and signatures are received and the Database Lock Form is fully executed on the "same day".

Make no mistake in the process, procedure, time, date or otherwise - it will invalidate the GIDB - now, the clinical submission GIDB has serious data integrity issues - sometimes reparable with GCP correction and communication with FDA, sometimes irreparable, sometimes - "a do over - the GIDB has to be created from the start" - first data point, first clinical study. Serious cost, timeline delays, quality management issues, perception of FDA - not good.

More to come from the Desk of Dante pertaining to the Clinical Submission GIDB - important points to consider.