(added F99/K00) PHS HESC N N Incl : Incl: Incl: If HESC If the answer to E New rule NIH, F05, be involved=’N’, ‘HESC involved’ ‘can’t F30, be is HESC ‘can’t “No”, referenced’ F31, Cell Lines may referenced’ checkbox FDA, checkbox cannot not be included January be selected and the be 14,2016 ‘Can’t F37, and/or cell Release, Update Referenced’ Form USU F38, line(s) cannot be checkbox must to Existing Rule FI2, provided. not be checked. (added F99/K00) PHS HESC Cell N N Incl : Incl: Incl: If specific stem Stem cell line E New rule NIH, F05, <cell line Lines cell line is F30, number> is included, provide F31, invalid. The cell error if stem cell FDA, line must be an January line is not in eRA approved line on 14,2016 database or is F37, the NIH Registry: Release, Update Form marked as USU F38, to Existing Rule FI2, (added invalid. F99/K00) Comparison should not be case-sensitive. PHS HESC Cell Lines Form
(added F99/K00) PHS Form HESC ‘can’t be referenced’ checkbox N N Incl : NIH, FDA, USU Incl: Incl: F05, F30, F31, F37, F38, FI2, If HESC involved=’N’, ‘can’t be referenced’ checkbox cannot be selected and/or cell line(s) cannot be provided. If the answer to ‘HESC involved’ is “No”, HESC Cell Lines may not be included and the ‘Can’t be Referenced’ checkbox must not be checked. E New rule January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Form HESC Cell Lines N N Incl : NIH, FDA, USU Incl: Incl: F05, F30, F31, F37, F38, FI2, If specific stem cell line is included, provide error if stem cell line is not in eRA database or is marked as invalid. Comparison should not be case-sensitive. Stem cell line <cell line number> is invalid. The cell line must be an approved line on the NIH Registry: E New rule January 14,2016 Release, Update to Existing Rule (added F99/K00) PHS Form HESC Cell Lines
eSub-validations-draft-08-21-2017.docx