From Facebook Ok. I’ve spent 22 years in big
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Posted On: 02/01/2021 5:00:56 PM
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Ok. I’ve spent 22 years in big pharma. Unblinding can only happen AFTER a few key steps. To-date, only the unblinded statistician has access to the blinding codes. Nobody else and cannot release them until there is a massive sign off of documents to allow for unblinding.
1.) Obviously all patients need to be finished with the study. Either had their last study visit (last study visit or died) or confirmed to be lost to follow-up.
2.) all patient data must be entered into the study database.
3.) all vendor data must be cleaned, validated by QC, and transferred into the study database.
4.) all patient data thats been entered must be ‘cleaned’ which means all discrepancies in the data must be corrected or explained.
5.) all SAEs must be reconciled against the clinical database.
6.) the database must be ‘frozen’ so no changes can be made. This is then reviewed by QC.
7.) draft tables, listings, and figures (TLFs) must be printed (PDF) for top line review. This will most likely be literally 10’s of thousands of pages of data that needs to be reviewed by the signatories to confirm accuracy of the clinical data. This could require several rounds of database corrections if errors are found.
8.) the statistical analysis plan (SAP) must be finalized and approved.
8.) once the draft TLFs are signed, only then can the signatures be made to certify that the database can be unblinded.
9.) the unblinded statistician is only then allowed to ‘flip the switch’ and unblind the study.
There are lots of details that would make this list way too long and cumbersome to type on my phone. This is not a quick process. I believe CYDY and the CRO are working at ‘warp speed’ - pardon the pun - to get this finished as soon as humanly possible. I’ve been hearing the switch will be flipped this week.
Ok. I’ve spent 22 years in big pharma. Unblinding can only happen AFTER a few key steps. To-date, only the unblinded statistician has access to the blinding codes. Nobody else and cannot release them until there is a massive sign off of documents to allow for unblinding.
1.) Obviously all patients need to be finished with the study. Either had their last study visit (last study visit or died) or confirmed to be lost to follow-up.
2.) all patient data must be entered into the study database.
3.) all vendor data must be cleaned, validated by QC, and transferred into the study database.
4.) all patient data thats been entered must be ‘cleaned’ which means all discrepancies in the data must be corrected or explained.
5.) all SAEs must be reconciled against the clinical database.
6.) the database must be ‘frozen’ so no changes can be made. This is then reviewed by QC.
7.) draft tables, listings, and figures (TLFs) must be printed (PDF) for top line review. This will most likely be literally 10’s of thousands of pages of data that needs to be reviewed by the signatories to confirm accuracy of the clinical data. This could require several rounds of database corrections if errors are found.
8.) the statistical analysis plan (SAP) must be finalized and approved.
8.) once the draft TLFs are signed, only then can the signatures be made to certify that the database can be unblinded.
9.) the unblinded statistician is only then allowed to ‘flip the switch’ and unblind the study.
There are lots of details that would make this list way too long and cumbersome to type on my phone. This is not a quick process. I believe CYDY and the CRO are working at ‘warp speed’ - pardon the pun - to get this finished as soon as humanly possible. I’ve been hearing the switch will be flipped this week.
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