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Posted On: 11/14/2021 4:42:52 PM
Post# of 148888
More from Aaron on the Sidley amended answer:
Aaron
From Sidley amended answer to court page 13, points 40, 41, 42.
"...Exhibit D (data management plan)... Provides for queries to be auto-generated by the EDC for quality control purposes. (Quoting the data management plan) "Once the data is entered queries will automatically be fired by the validation component of the program if discrepant and or erroneous...".
"Queries are supposed to be addressed (quoting from the data management plan) "daily upon generation of entries."
"However Amarex has failed to address some queries for months or even years.
"Amarex has also failed to close out study data as required by the study protocol.
"Amarex has covered up it's failures by making false statements to Cytodyn about the work it has performed."
From Exhibit D, (submitted by Sidley October 4th) Page 3-4
"... Cytodyn has undertaken to audit Individual trial sites that were managed by Amarex. A third-party auditor has identified significant failures at each trial site that has been audited to date, including that Amarex has failed to perform contractually required monitoring visits and has backdated certain records to make it appear that the required visits were timely performed.
"...A third-party consultant has estimated it will take months to rebuild Cytodyn's clinical data, if it can be done at all."
From Kazem Kazempour written testimony in Amarex answer, pages 6-7
"...Amarex seeks to solidify the accuracy of the (EDC) data by sending queries to the doctors offices or actually visiting the doctors offices.... So that the sites, NOT Amarex, may correct the inputted data into the EDC.
"This process of verification... demonstrates why doctors should not rely on the EDC data but rather...on the source records in their offices.
"...the entries in the EDC are not finalized with queries confirmed for accuracy until the EDC is locked, and it is not locked until the end of the study."
From the RTF, page 12 (FDA reviewer to Kazem Kazempour).
"...the data quality issues... which are extensive...may indicate that the process used to collect data...was flawed."
Aaron
From Sidley amended answer to court page 13, points 40, 41, 42.
"...Exhibit D (data management plan)... Provides for queries to be auto-generated by the EDC for quality control purposes. (Quoting the data management plan) "Once the data is entered queries will automatically be fired by the validation component of the program if discrepant and or erroneous...".
"Queries are supposed to be addressed (quoting from the data management plan) "daily upon generation of entries."
"However Amarex has failed to address some queries for months or even years.
"Amarex has also failed to close out study data as required by the study protocol.
"Amarex has covered up it's failures by making false statements to Cytodyn about the work it has performed."
From Exhibit D, (submitted by Sidley October 4th) Page 3-4
"... Cytodyn has undertaken to audit Individual trial sites that were managed by Amarex. A third-party auditor has identified significant failures at each trial site that has been audited to date, including that Amarex has failed to perform contractually required monitoring visits and has backdated certain records to make it appear that the required visits were timely performed.
"...A third-party consultant has estimated it will take months to rebuild Cytodyn's clinical data, if it can be done at all."
From Kazem Kazempour written testimony in Amarex answer, pages 6-7
"...Amarex seeks to solidify the accuracy of the (EDC) data by sending queries to the doctors offices or actually visiting the doctors offices.... So that the sites, NOT Amarex, may correct the inputted data into the EDC.
"This process of verification... demonstrates why doctors should not rely on the EDC data but rather...on the source records in their offices.
"...the entries in the EDC are not finalized with queries confirmed for accuracy until the EDC is locked, and it is not locked until the end of the study."
From the RTF, page 12 (FDA reviewer to Kazem Kazempour).
"...the data quality issues... which are extensive...may indicate that the process used to collect data...was flawed."
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