embryonic stem question. cells?” PHS 398 HESC N N V Both If specific stem Stem cell line <cell E Rule Cover NIH, 2.0 cell line is line number> is updated to Cell Lines Page CDC, included, provide invalid. The cell line apply to FDA, error if stem cell must be an approved AHRQ, line is not in eRA line on the NIH Only. USU database or is Registry: October marked as 2016 invalid. Release Comparison should not be case-sensitive. PHS 398 HESC N N V Both If Be You cannot provide E Rule ‘Can’t Cover Cell Lines NIH, 2.0 is updated to Referenced’ specific human Page CDC, checked, no cell apply to embryonic stem cell FDA, lines may be lines if you check the AHRQ, entered. Only. stem cell “Specific USU October lines cannot be 2016 referenced at this Release box. time” PHS 398 HESC N N V Multi over Y Specific stem Specific stem cells E Rule Cover Cell Lines NIH, 2.0 cells lines in lines in the Overall disabled Page CDC, overall should component should October FDA, reflect all stem reflect all stem cell 2016 AHRQ, cell lines included lines included in the Release USU in the components. components. Provide error if cell lines are listed in other components but not in the overall component Cover N N V Both Required if the You must answer the E Update to Page and 27.1 NIH, 2.0 all existing type of and “Inventions rule
embryonic stem cells?” question. PHS 398 Cover Page HESC Cell Lines N N NIH, CDC, FDA, AHRQ, USU V 2.0 Both 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 Rule updated to apply to Only. October 2016 Release PHS 398 Cover Page HESC Cell Lines N N NIH, CDC, FDA, AHRQ, USU V 2.0 Both If ‘Can’t Be Referenced’ is checked, no cell lines may be entered. You cannot provide specific human embryonic stem cell lines if you check the “Specific stem cell lines cannot be referenced at this time” box. E Rule updated to apply to Only. October 2016 Release PHS 398 Cover Page HESC Cell Lines N N NIH, CDC, FDA, AHRQ, USU V 2.0 Multi Y Specific stem cells lines in overall should reflect all stem cell lines included in the components. Provide error if cell lines are listed in other components but not in the overall component Specific stem cells lines in the Overall component should reflect all stem cell lines included in the components. E Rule disabled October 2016 Release Cover Page and N N NIH, V 2.0 Both Required if the type of You must answer the “Inventions and E Update to existing rule over all 27.1
eSub-validations-draft-07-12-2018.docx