Wednesday, April 07, 2021 1:37:45 PM
Another snippet from federalregister(dot)gov:
We're probably losing some context due to pulling sections out individually, but some interesting verbiage. The below are from various sections of the site.
The Study Completion Date is needed to assist responsible parties and viewers of the posted record to help identify when the final rule requirements for results information submission and obligations for updates and corrections in §?11.64 are fulfilled. Note that even though a responsible party for a trial may need to submit partial results information several times in order to meet different deadlines (i.e., because of different dates for final data collection for primary and/or secondary outcome measures or for the pre-specified time frame for collecting adverse events), that responsible party's obligation under subpart C continues until all required results information is submitted not later than 1 year following the Study Completion Date.
SAY WHAT? DO THEY ACTUALLY HAVE ANOTHER YEAR, NOW THAT THE POTENTIALLY OPTIONAL "STUDY COMPLETION DATE" HAS BEEN PROVIDED?
(9) Study Completion Date. This data element must be updated not later than 30 calendar days after a clinical trial reaches its actual study completion date.
(41) Study Completion Date means the estimated or actual study completion date. Once the clinical trial has reached the study completion date, the responsible party must update the Study Completion Date data element to reflect the actual study completion date in accordance with §?11.64(a)(1)(ii)(J) .
We're probably losing some context due to pulling sections out individually, but some interesting verbiage. The below are from various sections of the site.
The Study Completion Date is needed to assist responsible parties and viewers of the posted record to help identify when the final rule requirements for results information submission and obligations for updates and corrections in §?11.64 are fulfilled. Note that even though a responsible party for a trial may need to submit partial results information several times in order to meet different deadlines (i.e., because of different dates for final data collection for primary and/or secondary outcome measures or for the pre-specified time frame for collecting adverse events), that responsible party's obligation under subpart C continues until all required results information is submitted not later than 1 year following the Study Completion Date.
SAY WHAT? DO THEY ACTUALLY HAVE ANOTHER YEAR, NOW THAT THE POTENTIALLY OPTIONAL "STUDY COMPLETION DATE" HAS BEEN PROVIDED?
(9) Study Completion Date. This data element must be updated not later than 30 calendar days after a clinical trial reaches its actual study completion date.
(41) Study Completion Date means the estimated or actual study completion date. Once the clinical trial has reached the study completion date, the responsible party must update the Study Completion Date data element to reflect the actual study completion date in accordance with §?11.64(a)(1)(ii)(J) .
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