02617nas a2200445   4500000000100000008004100001260001500042653001700057653000900074653003600083653001700119100002100136700001600157700001700173700001700190700001800207700002200225700001700247700001900264700002200283700002300305700002500328700002000353700002300373700001700396700002100413700001700434700002000451700002600471700002400497700002000521700001900541700002000560245010200580856005000682300001200732490000600744520141200750022000902162       2023                            d  c2023-08-3110acell culture10aNAMs10aNext generation risk assessment10arisk of bias1 aCamilla Svendsen1 aPaul Whaley1 aGunn E. Vist1 aTrine Husøy1 aAnna Beronius1 aEmma Di Consiglio1 aIngrid Druwe1 aThomas Hartung1 aVasiliki I. Hatzi1 aSebastian Hoffmann1 aCarlijn R. Hooijmans1 aKyriaki Machera1 aJoshua F. Robinson1 aErwin Roggen1 aAndrew A. Rooney1 aNicolas Roth1 aEliana Spilioti1 aAnastasia Spyropoulou1 aOlga Tcheremenskaia1 aEmanuela Testai1 aMathieu Vinken1 aGro H. Mathisen00aProtocol for designing INVITES-IN, a tool for assessing the internal validity of in vitro studies  uhttps://doi.org/10.1080/2833373X.2023.2232415  a22324150 v13 aThis protocol describes the design and development of a tool for evaluation of the internal validity of in vitro studies, which is needed to include the data as evidence in systematic reviews and chemical risk assessments. The tool will be designed specifically to be applied to cell culture studies, including, but not restricted to, studies meeting the new approach methodology (NAM) definition. The tool is called INVITES-IN (IN VITro Experimental Studies INternal validity).In this protocol, three of the four studies that will be performed to create the release version of INVITES-IN are described. In the first study, evaluation of existing assessment tools will be combined with focus group discussions to identify how characteristics of the design or conduct of an in vitro study can affect its internal validity. Bias domains and items considered to be of relevance for in vitro studies will be identified. In the second study, group agreement on internal validity domains and items of importance for in vitro studies will be identified via a modified Delphi methodology. In the third study, the draft version of the tool will be created, based on the data on relevance and importance of bias domains and items collected in Studies 1 and 2. A separate protocol will be prepared for the fourth study, which includes the user testing and validation of the tool, and collection of users’ experience.  anull