I'll just keep repeating - all 44,000 "patients" were numbered with an 8 digit number:
[Site number e.g. 1006][Patient number, e.g. 1001]
The patient numbers are CONSECUTIVE.
Can you see the problem?
@AaronSiriSG @SenRonJohnson @joshg99 @ClareCraigPath
phmpt.org
[Site number e.g. 1006][Patient number, e.g. 1001]
The patient numbers are CONSECUTIVE.
Can you see the problem?
@AaronSiriSG @SenRonJohnson @joshg99 @ClareCraigPath
phmpt.org
I'll help.
The screenshot shows all the "site 1006" patient files uploaded in this week's document dump. They are now being uploaded as 1 pdf = 1 patient.
There were only 6 files = 6 patients.
The randomization log shows 1181 patients at that site
@fynn_fan @real_GGoswami
The screenshot shows all the "site 1006" patient files uploaded in this week's document dump. They are now being uploaded as 1 pdf = 1 patient.
There were only 6 files = 6 patients.
The randomization log shows 1181 patients at that site
@fynn_fan @real_GGoswami
@AaronSiriSG @SenRonJohnson @joshg99 @ClareCraigPath I'll help.
The screenshot shows all the "site 1006" patient files uploaded in this week's document dump. They are now being uploaded as 1 pdf = 1 patient.
There were only 6 files = 6 patients.
The randomization log shows 181 patients at that site
@fynn_fan @real_GGoswami
The screenshot shows all the "site 1006" patient files uploaded in this week's document dump. They are now being uploaded as 1 pdf = 1 patient.
There were only 6 files = 6 patients.
The randomization log shows 181 patients at that site
@fynn_fan @real_GGoswami
(Apologies for a typo in the previous version of this tweet, deleted and reposted)
Perhaps this may illustrate the point better...
This is the full randomization log for site 1006.
181 patients.
(The randomization log is 60Mb FYI...
phmpt.org)
@IamBrookJackson @ClareCraigPath @joshg99
This is the full randomization log for site 1006.
181 patients.
(The randomization log is 60Mb FYI...
phmpt.org)
@IamBrookJackson @ClareCraigPath @joshg99
I need to add this for clarification as there are claims that "not all the CRFs" have been released. This is not true in so far as they were ordered to be.
This is the plaintiff schedule that was adhered to (check the release log).
icandecide.org
This is the plaintiff schedule that was adhered to (check the release log).
icandecide.org
So the CRFs for those sites were already released in January in full in accordance with the schedule.
But they were only 3% of the randomised patients, which means any of the following....
But they were only 3% of the randomised patients, which means any of the following....
(1) The FDA only have 3% of the CRFs because only a sample were provided by Pfizer (which would contravene ICH-GCP and make the study subject to a full investigation)
(2) Pfizer only provided a sample now and defied the court order (contempt of court)
(3)...
(2) Pfizer only provided a sample now and defied the court order (contempt of court)
(3)...
..(3) the other CRFs don't exist or don't corroborate with @IamBrookJackson's and other research nurse records and so they were withheld.
That would indicate that the missing 42,800+ patients were synthesised or altered from the clinical record.
@JesslovesMJK
That would indicate that the missing 42,800+ patients were synthesised or altered from the clinical record.
@JesslovesMJK
Another corroboration is the consecutive numbering. All patients at each site are consecutively numbered in the randomization log. So if a sample of CRFs were agreed between the FDA & Pfizer anything other than consecutively numbered CRFs would warrant investigation
UPDATE: there are some trolls claiming that CRFs (case report/record forms) are only submitted for adverse events. Wrong. Those are AE or SAE reports.
CRFs are created for EVERY patient admitted to a clinical trial.
Here's the definitive guide.
ichgcp.net
CRFs are created for EVERY patient admitted to a clinical trial.
Here's the definitive guide.
ichgcp.net
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