ࡱ> <?9:;O 1bjbj&& lgLegLe"22a@a@@@@@@@8@B|@B3CLCCC7S7S7SMOOOOOO$Zs@7SAPR^7S7Ssa@a@CC  [ [ [7Sja@8C@CM [7SM [ [@ C S\̠SvuP90ŹDT @ 7S7S [7S7S7S7S7SssWF7S7S7S7S7S7S7S7S7S7S7S7S7S7S7S7S2 '?:  ROSSINI 2: Reduction Of Surgical Site Infection using several Novel Interventions A phase III, multi-arm, multi-stage (MAMS), pragmatic, blinded (patient and outcome assessor), multicentre, randomised controlled trial (RCT) with an internal pilot, to evaluate the use of several in-theatre interventions, alone or in combination, to reduce SSI rates in patients undergoing abdominal surgery. INFORMED CONSENT FORM Version 3.0, 12th July 2022 Site ID: ________________________________________________ Patient ID:  SHAPE \* MERGEFORMAT  SHAPE \* MERGEFORMAT  SHAPE \* MERGEFORMAT  SHAPE \* MERGEFORMAT  SHAPE \* MERGEFORMAT  Patient Initials:  SHAPE \* MERGEFORMAT  SHAPE \* MERGEFORMAT  SHAPE \* MERGEFORMAT  Principal Investigator:  SHAPE \* MERGEFORMAT  ________________________________________________ 1.I confirm that I have read and understood the patient information sheet, dated _ _ / _ _ / _ _ _ _ version number ______ for the ROSSINI 2 trial. I have had the opportunity to consider the information, ask questions, and have had these answered satisfactorily. 2.I understand that my participation is voluntary and that I am free to withdraw at any time without giving any reason and without my medical care or legal rights being affected. I understand that if I withdraw from the ROSSINI 2 trial, data collected up to my time of withdrawal may still be used. 3.I understand that relevant sections of my medical notes and data collected during the trial may be looked at by individuals from the ROSSINI 2 research team, representatives of the sponsor, from regulatory authorities or from the NHS Trust, where this is relevant to my taking part in this research. I give permission for these individuals to have direct access to my records.  4.I understand that information about me and my progress, including long term follow up data, will be supplied in confidence to the trial coordinators at the University 鶹ѡ Clinical Trials Unit (BCTU) by my own doctors for use in the ROSSINI 2 Trial. 5.I agree that my GP will be informed of my participation in this trial.6.I agree that, if needed, I can be contacted via telephone, email or post, by staff at my hospital or by research staff at Birmingham Clinical Trials (BCTU) to aid in the completion of any questionnaires whilst I am participating in the ROSSINI 2 Trial. 7.Data collected that contains my address, telephone number and email e.g. Contact Form and data collected that identifies me by name, e.g. Consent Forms, will be transferred from where it is collected and will be stored at the ROSSINI 2 Trials Office at the University 鶹ѡ, Birmingham Clinical Trials Unit (BCTU), if requested. I agree to the transfer and storage of this data.  8.I agree to the information held and maintained by NHS Digital, together with current and future UK NHS bodies, being used in the future to help contact me or to provide information about my long-term health status and health care. For this purpose, I agree to the University 鶹ѡ BCTU holding my name, gender, date of birth and NHS number. 9.I accept that, in the unlikely event of loss of my capacity, the research team will retain my personal data already collected and will continue to use this data for the sole purposes for which consent was sought. 10.I have read and understood the information in the patient information sheet about what will happen with my personal data collected for this trial. I understand that the information collected about me may be used to support other related research in the future, and may be shared anonymously with other researchers. 11.I agree to take part in the ROSSINI 2 trial and understand that I may be randomised to receive any, all, or none of the interventions under investigation.  Name of Patient Date Signature Name of Person taking Consent Date Signature When completed please provide a copy to the participant, forward a copy to the ROSSINI 2 Trials Office (if requested), retain a copy in the patients medical notes and file the original in the ROSSINI 2 Investigator Site File.     CONFIDENTIAL WHEN COMPLETE ________________________________________________________________________________  Informed Consent Form (IRAS TRIAL ID: 247285) Version 3.0, 12th July 2022 >Page  PAGE \* Arabic \* MERGEFORMAT 2 of  NUMPAGES \* Arabic \* MERGEFORMAT 3 CONFIDENTIAL WHEN COMPLETE ________________________________________________________________________________  Informed Consent Form (IRAS STUDY ID: 000000) Version 0.1 30th July 2018 Page  PAGE \* Arabic \* MERGEFORMAT 1 of  NUMPAGES \* Arabic \* MERGEFORMAT 2 Please initial inside each box     ޻u]H0/hJh=[5B*CJOJQJ]^JaJ$ph)h{5B*CJOJQJ]^JaJ$ph/h&h{5B*CJOJQJ]^JaJphEh&h&5B*CJOJQJ^JaJfHnH phq tH Eh&h&5B*CJOJQJ^JaJfHnH ph$q tH Eh&h&5B*CJOJQJ^JaJfHnH phKq tH &h5B*CJOJQJ^JaJ$phjhUmHnHu U g h k $Ifgdw $Ifgd| l$  a$gd%- xgda gda $ a$gd=$a$gdW $da$gd=[$%)*ABGHTUWX   鿩mUFh=5CJOJQJ^JaJ/hWhW56B*CJ$OJQJ^JaJ$ph_Iz+h&hDw6B*CJOJQJ]^Jph%hDw6B*CJOJQJ]^Jph%hd#6B*CJOJQJ]^Jph+h&hW6B*CJOJQJ]^Jph#h47h=[CJOJQJ]^JaJ$/hJh=[5B*CJOJQJ]^JaJ$ph,hJh=[B*CJOJQJ]^JaJ$ph zkYJ;Jh85OJQJ^JnH tH h=[5OJQJ^JnH tH #h ha5OJQJ^JnH tH h 5OJQJ^JnH tH ha5OJQJ^JnH tH &h=[h=[6CJOJQJ]^JaJh$r5CJOJQJ^JaJ&h$rh$r5CJH*OJQJ^JaJhL5CJOJQJ^JaJh~LI5CJOJQJ^JaJhf+V5CJOJQJ^JaJ#h=h=5CJOJQJ^JaJ  ! 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