SUNRR

SUNRR

that enhances the integrity of the study and includes require ments for sponsorship by an institution to ensure the following: peer review , independent ethics review , compliance with data protection principles , financial probity , dissemination and management of intellectual property . Sponsorship is defined by the HRA as the individual, company , institution or organisation that takes on ultimate responsibility for the initiation, management (or arranging the initiation and management) of and/or financing (or arrang ing the financing) for tha t research. The sponsor takes pri mary responsibility for ensuring that the design of the study meets appropriate standards and that arrangements are in place to ensure appropriate conduct and reporting (https:// www .hra.nhs.uk/planning-and-improving-research/research planning/roles-and-responsibilities/#sponsor).

SUNRRISE: S ingle U se N egative p site infection following Multicentre, prospective undergoing emergency RCT (minimum 25 general surgical units) Sample size calculation: 90% power to detect reduction of SSI at 30 days from 25% to 15% Predicted attrition rate of 20% 420 SUNPD Figure 13.1 SUNRRISE trial: protocol summary and recruitment /f_l owchart. Permission is granted by Birmingham Clinical Trials Unit, University of Birmingham, UK. RCT, randomised controlled trial; SSI, surgical site infection; SUNPD: single-use negative-pressure dressing.

SUNRR

that enhances the integrity of the study and includes require ments for sponsorship by an institution to ensure the following: peer review , independent ethics review , compliance with data protection principles , financial probity , dissemination and management of intellectual property . Sponsorship is defined by the HRA as the individual, company , institution or organisation that takes on ultimate responsibility for the initiation, management (or arranging the initiation and management) of and/or financing (or arrang ing the financing) for tha t research. The sponsor takes pri mary responsibility for ensuring that the design of the study meets appropriate standards and that arrangements are in place to ensure appropriate conduct and reporting (https:// www .hra.nhs.uk/planning-and-improving-research/research planning/roles-and-responsibilities/#sponsor).

SUNRRISE: S ingle U se N egative p site infection following Multicentre, prospective undergoing emergency RCT (minimum 25 general surgical units) Sample size calculation: 90% power to detect reduction of SSI at 30 days from 25% to 15% Predicted attrition rate of 20% 420 SUNPD Figure 13.1 SUNRRISE trial: protocol summary and recruitment /f_l owchart. Permission is granted by Birmingham Clinical Trials Unit, University of Birmingham, UK. RCT, randomised controlled trial; SSI, surgical site infection; SUNPD: single-use negative-pressure dressing.

SUNRR

that enhances the integrity of the study and includes require ments for sponsorship by an institution to ensure the following: peer review , independent ethics review , compliance with data protection principles , financial probity , dissemination and management of intellectual property . Sponsorship is defined by the HRA as the individual, company , institution or organisation that takes on ultimate responsibility for the initiation, management (or arranging the initiation and management) of and/or financing (or arrang ing the financing) for tha t research. The sponsor takes pri mary responsibility for ensuring that the design of the study meets appropriate standards and that arrangements are in place to ensure appropriate conduct and reporting (https:// www .hra.nhs.uk/planning-and-improving-research/research planning/roles-and-responsibilities/#sponsor).

SUNRRISE: S ingle U se N egative p site infection following Multicentre, prospective undergoing emergency RCT (minimum 25 general surgical units) Sample size calculation: 90% power to detect reduction of SSI at 30 days from 25% to 15% Predicted attrition rate of 20% 420 SUNPD Figure 13.1 SUNRRISE trial: protocol summary and recruitment /f_l owchart. Permission is granted by Birmingham Clinical Trials Unit, University of Birmingham, UK. RCT, randomised controlled trial; SSI, surgical site infection; SUNPD: single-use negative-pressure dressing.