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Posted On: 01/22/2021 10:41:52 AM
Post# of 153992
Cut and pasted this from a different board.
I believe it answers you “what is locked” question.
Sites will have 24hrs to enter the data in to the EDC system. Data monitoring and Data cleaning will be performed and queriers will be raised and the sites will have to respond to those queries. There is vendor data to be finalized as well. The safety labs, cytokine panels etc all come from the vendors. Each and every data point has to be reconciled and the database has to be locked. Pandemic or No pandemic the FDA is very strict about Data Integrity. If there are any mistakes during this process, the database has to be unlocked, corrected and locked. Trust me nobody wants to go through that.
I believe it answers you “what is locked” question.
Sites will have 24hrs to enter the data in to the EDC system. Data monitoring and Data cleaning will be performed and queriers will be raised and the sites will have to respond to those queries. There is vendor data to be finalized as well. The safety labs, cytokine panels etc all come from the vendors. Each and every data point has to be reconciled and the database has to be locked. Pandemic or No pandemic the FDA is very strict about Data Integrity. If there are any mistakes during this process, the database has to be unlocked, corrected and locked. Trust me nobody wants to go through that.
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