ࡱ> g bjbj ;zxqbxqb!00f>f>f>f>f>z>z>z>8>?z>r*@BL&C&C&C[2&\:\ fhhhhhh$Ytf>V>>&&___>&>&___*<&Cv"Y]|RR0j]f<<nf> F\F\_F\F\F\F\F\^F\F\F\F\F\F\F\F\F\F\F\F\F\F\F\F\0B ,=:  Informed Consent Form Study Title: A Personalised Early Warning Decision Support System to Predict and Prevent Acute Exacerbations of Chronic Obstructive Pulmonary Disease - 'Predict&Prevent AECOPD'" Site name .. Principal Investigator Patient Initials:  SHAPE \* MERGEFORMAT  SHAPE \* MERGEFORMAT  SHAPE \* MERGEFORMAT  Please read and initial the following declarations if you would like to take part: Please initial inside each box 1I confirm that I have read and understood the information sheet, version number __ . __ , dated _ _ / _ _ / _ _ _ _ for the Predict&Prevent AECOPD Clinical Investigation. I have had the opportunity to consider the information, ask questions, and have had these answered satisfactorily. SHAPE \* MERGEFORMAT 2I 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 data collected up to my time of withdrawal may be used.  SHAPE \* MERGEFORMAT 3I understand that relevant sections of my medical notes and data collected during the study may be looked at by individuals from the Predict&Prevent AECOPD Clinical Investigation 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.  SHAPE \* MERGEFORMAT 4I agree to my GP being informed of my participation in this study and that they may be contacted by members of the research team for follow-up information.5Data collected that identifies me by name, e.g. consent forms, will be transferred from where it is collected to a web-host physically located in Gloucester. Data will also be forwarded to the University 鶹ѡ during the trial and subsequently at a specialist archiving facility, in compliance with current regulations, after the trial. I agree to the transfer and storage of this data. 6To permit the accurate follow-up of all participants it may be necessary for the Predict&Prevent AECOPD Clinical Investigation Office to contact other UK NHS bodies to provide information about your health status. I hereby give consent for the use of information held and maintained by e.g. the Health and Social Care Information Centre and other central UK NHS bodies to contact participants or provide information about their health status. 7I agree to take part in the Predict&Prevent AECOPD Clinical Investigation.8 I agree to my GP being informed of my participation in this study. 9OPTIONAL: I agree to being contacted about participating in the Predict&Prevent AECOPD Qualitative Study (in depth discussions about your experience of managing COPD and of the study).  Name of Participant Signature  Date Participant Signed  SHAPE \* MERGEFORMAT  SHAPE \* MERGEFORMAT / SHAPE \* MERGEFORMAT  SHAPE \* MERGEFORMAT  SHAPE \* MERGEFORMAT / SHAPE \* MERGEFORMAT  SHAPE \* MERGEFORMAT  SHAPE \* MERGEFORMAT  SHAPE \* MERGEFORMAT Researcher Name Signature  Date Researcher Signed  SHAPE \* MERGEFORMAT  SHAPE \* MERGEFORMAT / SHAPE \* MERGEFORMAT  SHAPE \* MERGEFORMAT  SHAPE \* MERGEFORMAT / SHAPE \* MERGEFORMAT  SHAPE \* MERGEFORMAT  SHAPE \* MERGEFORMAT  SHAPE \* MERGEFORMAT  Information below to be added upon successful randomisation  Patient ID:  SHAPE \* MERGEFORMAT  SHAPE \* MERGEFORMAT  SHAPE \* MERGEFORMAT  SHAPE \* MERGEFORMAT  SHAPE \* MERGEFORMAT  Date Patient ID added by Researcher  SHAPE \* MERGEFORMAT  SHAPE \* MERGEFORMAT / SHAPE \* MERGEFORMAT  SHAPE \* MERGEFORMAT  SHAPE \* MERGEFORMAT / SHAPE \* MERGEFORMAT  SHAPE \* MERGEFORMAT  SHAPE \* MERGEFORMAT  SHAPE \* MERGEFORMAT  Researcher Name Signature      Print on Hospital Headed Paper Predict&Prevent AECOPD Patient Consent Form ________________________________________________________________________________ When completed: 1 for participant, 1 for Investigator Site File, 1 (original) to keep in medical notes, 1 sent to Predict&Prevent AECOPD Clinical Investigation Office. Predict & Prevent ICF Version 4.0, 04-Jun-2021 IRAS 261576 Page  PAGE \* Arabic \* MERGEFORMAT 2 of  NUMPAGES \* Arabic \* MERGEFORMAT 2 Print on Hospital Headed Paper Version 1.1, 11-Nov-2019 IRAS 261576 Page  PAGE \* Arabic \* MERGEFORMAT 1 of  NUMPAGES \* Arabic \* MERGEFORMAT 2 )*+79:Ͻ{jSkd$$IfF`#@'  t0E'    494 ayt9$ qq$If]q^qa$gd$}$If]}^a$gd(*uw$ qq$If]q^qa$gd x $IfYDx^gd $ x $IfYDx]a$gd0Fstuvwxyz{̷p^M8-h=Lh=LCJaJ)h=Lh=LB*CJPJaJnH phtH  h=Lh=LCJPJaJnH tH "h=LCJOJQJ^JaJnH tH "h :CJOJQJ^JaJnH tH /h0hLCJOJQJ^JaJmHnHtH u8jh0h CJOJQJU^JaJmHnHtH u(h0h=LCJOJQJ^JaJnH tH (h0hLCJOJQJ^JaJnH tH <h0hL5CJOJQJ^JaJfHnH q tH  wxz{pZHH5$7$8$H$Ifgd=LK$$7$8$H$Ifgd=L$ $If]a$gd0kdb$$IfF`#@'  t0E'    494 ayt9p$ qq$If]q^qa$gd=L $If^gd=L`kd $IfK$L$l04 layt/0~ιn[H6n"h6CJOJQJ^JaJnH tH %h65CJOJQJ^JaJnH tH %h 5CJOJQJ^JaJnH tH "hvCJOJQJ^JaJnH tH (hJ5>*CJOJQJ^JaJnH tH "h CJOJQJ^JaJnH tH "h :CJOJQJ^JaJnH tH (h0h=LCJOJQJ^JaJnH tH /h0h=LCJOJQJ^JaJmHnHtH u2jh=LCJOJQJU^JaJmHnHtH u pZG-$ qq$If]q^qa$gd $If^gd6$ $If]a$gd0kd$$IfF`#@'  t0E'    494 ayt=L!%:;ѹtm`P`71jhhCJOJQJU^JaJnH tH hh5CJOJQJaJh5CJOJQJaJ h,hP&h0h5CJOJQJaJh0hP&5CJOJQJaJh0h <CJOJQJaJ(h0h CJOJQJ^JaJnH tH /h0h CJOJQJ^JaJmHnHtH u2jh CJOJQJU^JaJmHnHtH u(h6h CJOJQJ^JaJnH tH  pgQ P$&`#$/IfgdG.gd kd? $$IfF`#@'  t0E'    494 ayt=L9v P$&`#$/IfgdG.rkd $$Ifl>%% t 6`0%44 laytG.;RSTUWnopqrstҵҵqҵXҵ?1j* hhCJOJQJU^JaJnH tH 1j hhCJOJQJU^JaJnH tH "hCJOJQJ^JaJnH tH 1j hhCJOJQJU^JaJnH tH 1jz hhCJOJQJU^JaJnH tH 8jhhCJOJQJU^JaJmHnHtH u1jhhCJOJQJU^JaJnH tH (hhCJOJQJ^JaJnH tH 456ʱqX?1jjhhCJOJQJU^JaJnH tH 1j hhCJOJQJU^JaJnH tH 1jJ hhCJOJQJU^JaJnH tH (hhCJOJQJ^JaJnH tH "hCJOJQJ^JaJnH tH 1jhhCJOJQJU^JaJnH tH 1j hhCJOJQJU^JaJnH tH 8jhhCJOJQJU^JaJmHnHtH u6789:DIN`nopͽs^A8jhhCJOJQJU^JaJmHnHtH u(hhCJOJQJ^JaJnH tH hh5CJOJQJaJh5CJOJQJaJ h,hP&h0hP&CJOJQJaJh0hP&5CJOJQJaJ h,hh0h5CJOJQJaJ1jhhCJOJQJU^JaJnH tH 1jhhCJOJQJU^JaJnH tH 9:ov P$&`#$/IfgdG.rkd$$Ifl%% t 6`0%44 laytG.opv P$&`#$/IfgdG.rkd$$Ifl%% t 6`0%44 laytG.     %&'(*ABCDF]^_͸͛p͸͛W͸͛>͸͛1jNhhCJOJQJU^JaJnH tH 1jhhCJOJQJU^JaJnH tH "hCJOJQJ^JaJnH tH 1j.hhCJOJQJU^JaJnH tH 8jhhCJOJQJU^JaJmHnHtH u(hhCJOJQJ^JaJnH tH 1jhhCJOJQJU^JaJnH tH 1jhhCJOJQJU^JaJnH tH _`abcz{|}ͻ͉ͦp͉ͦW͉ͦ>͉ͦ1jhhCJOJQJU^JaJnH tH 1jhhCJOJQJU^JaJnH tH 1jnhhCJOJQJU^JaJnH tH 8jhhCJOJQJU^JaJmHnHtH u(hhCJOJQJ^JaJnH tH "hCJOJQJ^JaJnH tH 1jhhCJOJQJU^JaJnH tH 1jhhCJOJQJU^JaJnH tH /ͽuYuF0+h0h5CJOJQJ^JaJnH tH %h05CJOJQJ^JaJnH tH 7jh0h6CJOJQJUaJmHnHtH uh0h6CJOJQJaJhTCJOJQJhCJOJQJ(h'EhaCJOJQJ^JaJnH tH h-h-< h,hh0h5CJOJQJaJ1jhhCJOJQJU^JaJnH tH 1jhhCJOJQJU^JaJnH tH  oa\\\\\\gd $ a$gd$ ,"xa$gdagd-rkd$$Ifl%% t 6`0%44 laytG.  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