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Posted On: 02/17/2021 3:59:40 PM
Post# of 148899
Re: ombowstring #78379
ombowstring,
Ohm and others know better than I. However, data cannot be analyzed until it is verified as complete and correct. Amarex (the CRO) verifies data with each trial site, correcting errors (I assume they look for data points outside expected ranges and verify each questionable data point) and collecting missing data points.
Only after the data is verified as complete and correct (as far as they are able to determine) is the database locked.
The locked database remains a permanent record, subject to audit at any point.
Once locked, the data is unblinded (revealing which patient received Leronlimab versus placebo).
The analysis (I believe mostly computer driven based on analytical tools and processes established at the outset of the trial) should be the quicker part of the process.
Ohm and others know better than I. However, data cannot be analyzed until it is verified as complete and correct. Amarex (the CRO) verifies data with each trial site, correcting errors (I assume they look for data points outside expected ranges and verify each questionable data point) and collecting missing data points.
Only after the data is verified as complete and correct (as far as they are able to determine) is the database locked.
The locked database remains a permanent record, subject to audit at any point.
Once locked, the data is unblinded (revealing which patient received Leronlimab versus placebo).
The analysis (I believe mostly computer driven based on analytical tools and processes established at the outset of the trial) should be the quicker part of the process.
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