' at the beginning of each form. Name and contact information of all individuals have been anonymised by replacing the original text with the generic tag 'xxxx' enclosed in angled brackets. Identification information about universities, trial units, associated research ethics committees, or settings where the RCTs were conducted have been anonymised in the same way. Funder information and web links have been retained when they do not reveal institutional information. The name of the RCT and its acronym have also not been anonymised. The text for two consent forms is not provided here for copyright reasons and has been replaced by a web link to the online ethical documents.> Study Number: Patient Identification Number for this study: CONSENT FORM Title of Project: DEUS pilot study: Diet and Exercise in Uterine Cancer Survivors (Student Study) Name of Researcher: Please initial all boxes 1. I confirm that I have read and understand the information sheet dated 17/03/15 (version 3.0) for the above study. 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, without my medical care or legal rights being affected. 3. I understand my medical records will be reviewed by relevant researchers in this study. 4. I understand that relevant sections of my medical notes and data collected during the study may be looked at by individuals from , from regulatory authorities or from the NHS Trust, where it is relevant to my taking part in this research. I give permission for these individuals to have access to my records. 5. I agree to have the sessions and telephone interviews audio recorded. 6. I understand that I will not benefit financially if this research leads to the development of a new manual about cancer. 7. I agree that my GP will be informed about my participation in the study. 8. I agree to take part in the above study. Name of Participant Date Signature Name of Person Date Signature taking consent. Patient Identification Number: Name of Researcher: Title of the trial: A phase III trial of Prophylactic Irradiation of Tracts in patients with malignant pleural mesothelioma following invasive chest wall intervention (PIT Trial) CONSENT FORM 1. I confirm that I have read and understood the information sheet Version 4.0, dated 19 April 2012 for the above trial and have had the opportunity to ask questions. 2. I understand that my participation is voluntary and that I am free to withdraw at any time, without giving any reason, without my medical care or legal rights being affected. 3. I understand that sections of any of my medical notes may be looked at by responsible individuals from [insert institution name] and its authorised agents or from Regulatory Authorities where it is relevant to my taking part in research. I give permission for these individuals to have access to my records. 4. I also understand that if I withdraw from the trial early, the data collected whilst I was on the trial will be retained to ensure the trial has been run in accordance with all applicable rules. 5. I understand that if I lose the capacity to consent I will be withdrawn from the study. However any identifiable data already collected with consent would be retained and used in the study 6. I understand that I will not benefit financially if this research leads to the development of a new treatment or medical test 7. I understand that my General Practitioner will be informed about my participation in this trial. 8. I agree to take part in the above trial. Please initial in boxes Name of Patient Date Signature Name of Person taking consent (If different from researcher) Date Signature Researcher Date Signature Thank you for taking part in this research trial TWO TABLES PATIENT CONSENT FORM Surgical and large bore pleural procedures in malignant pleural Mesothelioma and Radiotherapy Trial (SMART) A randomised controlled trial evaluating whether prophylactic radiotherapy reduces the incidence of procedure tract metastases. 1. I confirm that I have read and understand the patient information sheet dated (Version ) for the above study. 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 future medical care or legal rights being affected as a consequence. 3. I understand that relevant sections of my medical notes and data collected during the study may be looked at by individuals involved in the running of the trial, from the regulatory authorities or from the NHS, where it is relevant to my taking part in the research. I give permission for these individuals to have access to my records. 4. I give permission for my trial data, some of which may identify me, to be transported from my hospital site to the trial coordinating centres at and for the purposes of analysis, monitoring and follow up. 5. I understand that information held by the NHS and records maintained by the NHS Information Centre and the NHS Central Register may be used to help contact me and provide information about my health status. 6. I agree to take part in this study. 7. I would like my GP (Dr ) to be notified about my participation in the study and I give my permission for you to contact them. 8. Would you like to know the results of the trial when they are published? Name of patient Date (dd/mm/yyyy) Signature Name of researcher Date (dd/mm/yyyy) Signature For more information concerning the research and research related risks or injuries, I can contact Dr., the investigator in charge at (Tel). In addition, I may contact at (Tel) for information regarding patients' rights in research studies. The name of an individual not involved with this study with whom I may discuss issues related to my participation in this study is: Telephone The name of the principal investigator for this project at this centre: Telephone By signing this consent form, I am indicating that I agree to participate in this study. SIGNATURE OF PATIENT DATE SIGNATURE OF INVESTIGATOR DATE Name of Researcher: Please initial box to agree 1. I confirm that I have read and understand the patient information sheet dated (version) for the above study and have had the opportunity to ask questions. 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. 3. I understand that my GP will be kept up to date regarding my treatment. 4. I understand that sections of any of my medical notes may be looked at by responsible individuals involved in the running of the trial or from regulatory authorities where it is relevant to my taking part in research. I give permission for these individuals to have access to my records. 5. I give permission for the Clinical Trials Unit at to store my full name on a secure database and register my name and NHS number with the Office for National Statistics (ONS) should I lose contact with my study doctor 6. I give permission for a copy of my consent form to be sent to the Clinical Trials Unit at (where it will be kept in a secure location, separate from my patient notes), to allow confirmation that my consent was given. 7. I agree to take part in the above study. 8. I agree that my carer (please state carer’s name) may take part in the above study. If this question is not applicable please write N/A in this box Name of Patient Date Signature Name of Person taking consent Date Signature (if different from researcher) The ROAM trial Radiation versus Observation following surgical resection of Atypical Meningioma: a randomised controlled trial Name of principal investigator: Adult Consent Form Please initial box 1. I confirm that I have read and understand the information sheet dated 26th November 2014 (version 1.0) for the above study. I have had the opportunity to consider the information, ask questions and have these answered satisfactorily. 2. I understand that participation is voluntary and that I am free to withdraw at any time, without giving a reason, and without my care or legal rights being affected. 3. I understand that relevant sections of any of my medical notes and data collected during the study may be looked at by responsible individuals from the research team, regulatory authorities, sponsor or from the NHS Trust, where it is relevant to me taking part in this study. I give permission for these individuals to have access to my records. 4. I understand that my medical data will be collected for this study and may be used to develop new research and that data protection regulations will be observed. 5. I agree for my data on NHS hospital admissions to be collected from electronic routine NHS health care records. 6. I understand that the tumour and blood samples that I have donated – approximately 10 mls of blood (2 teaspoons) for storage in the study biobank may be used for further research, including genetic testing, as described in this information sheet. 7. I agree to medical personnel responsible for my welfare being informed of my participation in the study. 8. I agree to take part in the above study. 9. I understand that my GP will be notified. I agree that I may be contacted in the future in relation to this study for further research. Yes No Name of Patient Signature Date Name of person taking consent (designated responsible person) Signature Date Study Number: PATIENT CONSENT FORM Title of Project: COMICE Trial – Examining the comparative effectiveness of contrast enhanced high field MRI in women scheduled for wide local excision Research Nurse: 1. I confirm that I have read and understand the information sheet dated (version ) for the above study and have had the opportunity to ask questions. 2. I understand that my participation is voluntary and that I am free to withdraw at any time, without giving any reason, without my medical care or legal rights being affected. 3. I understand that sections of any of my medical notes may be looked at by responsible individuals from the research staff or from regulatory authorities where it is relevant to my taking part in research; I give permission for these individuals to have access to my records. 4. I understand that my medical data will be collected for this study and may be used to help develop new research, and that data protection regulations will be observed and strict confidentiality maintained. 5. I consent to donation of surplus tissue left over from my breast surgery, that is not required for diagnosis and treatment, to be used for laboratory research into breast disease. 6. I consent to the storage, including electronic, of personal information for the purposes of this study. I understand that any information that could identify me will be kept strictly confidential and that no personal information will be included in the study report or other publication. 7. I agree to take part in the above study. Name of Patient Date Signature Name of Researcher taking consent Date Signature Centre Name: Patient ID Number: Name of Researcher taking consent: 1. I confirm that I have read and understood the information sheet for the Add Aspirin research study (version 4.0, 11-Nov-2014) and have been given a copy to keep. I have had the opportunity to ask questions about the study and discuss it with my doctor and I have received satisfactory answers to all of my questions. 2. I understand that sections of any of my medical notes may be looked at by responsible individuals from the Medical Research Council (MRC) Clinical Trials Unit (CTU) or from regulatory authorities where it is relevant to my taking part in this research study. I give permission for these individuals to have access to my records, but understand that my confidentiality will be maintained. 3. I understand that my GP will be informed of my participation in the research study. 4. I understand that I may not benefit directly by participating in this study but that the research may help people with this condition in the future. 5. I understand that my participation in all aspects of this study is voluntary and that I am free to withdraw from the study at any time, without giving any reason and without my medical care or legal rights being affected. 6. I agree to take part in the above study. The following parts of the study are optional – you can decide about each one separately but still take part in the study. 7. In order to follow up on my health status after my participation in the study, I give permission for my name and NHS number (CHI number in Scotland) to be used to obtain information about my health status, for example, from records held by the NHS and maintained by the NHS Information Centre and the NHS Central Register or any applicable NHS information system. I understand that this will take place even if I am not randomised after registration. Patient ID Number: 8. I give permission for a copy of this consent form to be sent to the (where it will be logged before being destroyed), to show that my consent was given. 9. I give permission for my contact details to be used to contact me directly with information and updates about the progress of the study and the final results of the study. 10. I give permission for my stored cancer samples to be made available for future research including DNA analysis. 11. I give permission for a blood sample to be taken when I register for the study and give permission for this to be made available for future research, including DNA analysis. 12. I understand that my samples may be used in research, including non routine genetic tests. There will be no individual results available from this research unless they affect my clinical care, whether for this cancer, or in regards to other serious or life threatening medical conditions for me or my family. 13. I understand that my anonymised samples and/or anonymised data (including data collected through NHS information systems may be used in future research, and this may be carried out by researchers other than UCL. Studies using data and/or samples collected in the trial will only take place after scientific and ethical review. Name of Participant (BLOCK CAPITALS) Date (dd/mm/yyyy) Signature Name of Researcher (BLOCK CAPITALS) Date (dd/mm/yyyy) Signature Name of Person asking for consent (if different from researcher) (BLOCK CAPITALS) To be completed after run in period and prior to randomisation: 15. I have completed the run in period and now give my permission to continue in this study and be randomised. Name of Participant (BLOCK CAPITALS) Date (dd/mm/yyyy) Signature Name of Researcher (BLOCK CAPITALS) Date (dd/mm/yyyy) Signature Name of Person asking for consent Date (dd/mm/yyyy) Signature (if different from researcher) (BLOCK CAPITALS) Mammo-50: Mammographic surveillance in breast cancer patients aged 50 years or older Principal Investigator: Study Site: Please initial the boxes below if you agree. Initials I confirm that I have read and understand the MAMMO-50 Patient Information Sheet Version (), Dated (). I understand what is involved in taking part and have had the opportunity to consider the information and ask questions. All of my questions have been answered satisfactorily. I understand that my participation is voluntary and that I am free to withdraw from the study at any time without giving a reason and without my medical care or legal rights being affected. I understand that MAMMO-50 may be stopped at any time without my consent if it is believed it is in the best interest of study participants. I give permission for the MAMMO-50 Trial Office to hold a record of my personal details, which includes my NHS/CHI number, name, initials, address and date of birth. This will be used for tracking me through the Health and Social Care Information Centre (HSCIC), Office of National Statistics (ONS) and other relevant bodies to provide information about my health status. All data which identifies me will be kept on a secure database, only be used for the above purpose and only accessed by trial personnel. I understand that data collected for this study is covered by the Data Protection Act (1998) and all electronic data will be stored in a secure format. I understand that relevant sections of any of my medical notes and data collected during the study, may be looked at by responsible individuals and/or authorised representatives from the (study sponsors) from regulatory authorities, or from the NHS Trust, where it is relevant to my taking part in this research. I give permission for such individuals to have access to my medical records which will identify me by name. This permission is extended to other UK Regulatory Authorities for the purposes of monitoring the conduct of the study. I understand that I will not be identified in any study reports or publications. I give my permission for a letter about my involvement in MAMMO-50 to be sent to my General Practitioner which will contain information about the study. I give my permission for the NHS Breast Screening Programme to be informed about my participation in Mammo-50. I agree not to attend routine NHS breast screening appointments whilst I am participating in the Mammo-50 study and if I am invited I will ring the service to cancel my appointment. I agree to complete questionnaires about the impact of my involvement in the study. I give my permission for my mammograms to be collected and the information to be shared with research collaborators as part of this trial. Please initial the boxes below if you agree. Initials OPTIONAL: I agree to take part in a sub study to assess my quality of life which will involve completing additional questionnaires and for information to be shared with my clinical team if appropriate. OPTIONAL: I agree to be invited to take part in a qualitative interview based study, which will explore in depth the views and experience of surveillance mammography and breast cancer follow up and I give my permission for my contact details to be shared with trial personnel. OPTIONAL: I agree to donate a tissue sample from my original surgery and any future recurrence for additional research and the information will be shared with research collaborators, if necessary. I understand that donating samples is a gift for this research, that it is entirely voluntary and that I am free to withdraw my approval for use of the samples at any time without giving a reason and that my medical treatment or legal rights will not be affected by this voluntary donation. OPTIONAL: I agree to be contacted to check my willingness to take part in future studies. I voluntarily agree to participate in this study. Participant signature: Name (print): Date signed: Investigator Statement and Signature. To be completed by the investigator/designee taking consent I have discussed this study using a language that is understandable and appropriate. I believe I have fully informed the participant of the nature of the study, any possible benefits and risks of taking part and she has understood this explanation Signature: Name (print): Date signed: The completed consent form must be kept in the MAMMO-50 site file, a copy given to participant and a copy filed in hospital notes. Do not send the completed consent form to the MAMMO-50 Trial Office. Trial Consent Form Simple treatment for urinary incontinence in men after prostate surgery (MAPS) Conservative treatment for men with urinary incontinence after prostate surgery: multicentre randomised controlled trial of pelvic floor muscle training and biofeedback By signing this form and ticking each box I agree that: I have: - been given the Information Sheet about the study (Version 7, February 2005) - had the opportunity to discuss the study - received satisfactory answers to questions - been given enough information about the study I understand that: - taking part in the study may not benefit my own health - I am free to withdraw from the study at any time without having to give a reason - if I withdraw, this will not affect my care - information relevant to the MAPS study may be collected from my hospital and NHS records, including Office of National Statistics (ONS) and NHS central registers I agree to take part in the study I agree that my family doctor (GP), my hospital Urological Consultant and the person I have nominated as my Best Contact may be told that I am taking part in this study Your signature (participant) Your name in block capitals Date I confirm that I have explained to the person named above, the nature and purpose of the study and the procedures involved Signature Date Study ID number of participant Hospital number of participant MAPS Study Office, Trial Number for this study: ……..……………. (to be added after randomisation) Name of local investigator: ……………………………………………… INFORMED CONSENT FORM A study to find out the best form of follow up after surgery for bowel cancer. Please initial every box 1. I confirm that I have read and understand the Patient Information Sheet (Version 9, dated 04/12/07) for the above study and have had the opportunity to ask questions. 2. I understand that my participation is voluntary and that I am free to withdraw at any time, without giving any reason, without my medical care or legal rights being affected. I agree that the study team can continue to contact my hospital doctor/nurse to request information about my future treatment and care. 3. I understand that sections of any of my medical notes may be looked at by responsible individuals from the study group or from regulatory authorities where it is relevant to my taking part in research. I give permission for these individuals to have access to my records. 4. I understand that some of my personal details will be known to the coordinating team, to enable direct correspondence with me. I understand that these details will be stored on computers, but will only be available to authorised members of the team and will not be given to anybody else. 5. I give permission for a copy of my Informed Consent Form to be sent to the coordinating team (where it will be kept in a secure location), to allow confirmation that my consent was given. 6. I understand that information held by the NHS and records maintained by the Office of National Statistics (ONS) may be used to follow up my health status. 7. I agree to my G.P. being informed of my participation in this study and being involved if required. 8. I agree to take part in the above study. Name of Patient Date Signature (please print) Name of Person Taking Consent Date Signature (if different to local investigator) Local Investigator Date Signature (please print) TRAPEZE Research Trial of Treatments for Patients with Bony Metastatic Cancer of the Prostate Patient Consent Form I have been given a copy of the Patient Information Sheet (version 4, 12-Apr-2011) for this study. I have read and understood it and I have had the opportunity to ask questions and discuss the study. Please initial If I want to ask any further questions I understand that I may contact the Study Doctor or his/her colleagues or staff. I understand that I must tell the Study Doctor (or his/her nominee) if I notice any unusual or unexpected effects or if my health changes. I give permission for my GP to be informed of my participation and sent details of the study. I give permission for my name and a copy of this consent form, to be given to the study office when I am registered into the study. I understand that my medical records may need to be reviewed by responsible individuals from the trials office, or from regulatory authorities where it is relevant to my taking part in research. I give permission for these individuals to have access to my records. However, I understand that I will not be identified by name in any reports or publications resulting from this study. I also understand that data collected about me for this study will be held under the provisions of the 1998 Data Protection Act and will be stored in manual and electronic files in a secure encoded format I understand that I may withdraw from the Study at any time, without giving a reason and without affecting any medical treatment I will receive. I give permission for ONS (Office of National Statistics) to pass information on from my records for the TRAPEZE trial. I voluntarily agree to participate in the TRAPEZE study. I give permission for samples of tissue previously taken (Tissue blocks) and tissue left over from Surgery and routine investigations to be used for related laboratory research that may be conducted in the future. (If the answer to this question is ‘NO’, you may still take part in this study) YES NO I give permission for extra blood samples to be taken and used for additional related laboratory studies. I understand that I am free to withdraw my approval for use of these samples at any time without giving a reason and without my medical care and legal rights being affected. (If the answer to this question is ‘NO’, you may still take part in this study) YES NO I have been given a copy of the quality of life Patient Booklet and I agree to take part in the quality of life study. (If the answer to this question is ‘NO’, you may still take part in this study) YES NO Name of Patient Signature Date I certify that I have explained to the above patient the nature and purpose, the potential benefits, and possible risks associated with participation in this research study. I have answered all questions that have been raised. Name of Investigator Signature Date ARTISTIC A Randomised Controlled Trial In Screening To Improve Cytology Consent Form 1. I confirm that I have read and understood the Information Leaflet dated 15/03/08 (version 9) for the above study and have had the opportunity to ask questions. 2. I understand that my participation is voluntary and that I am free to withdraw at any time, without giving a reason, without my medical care or legal rights being affected. 3. I understand that relevant sections of any of my medical notes may be looked at by responsible individuals from the Health Technology Assessment Programme or from regulatory authorities. I give permission for these individuals to have access to relevant sections of my records. 4. I understand that the NHS Cervical Screening (xxxx) database may be used to ensure my smear records are complete for the duration of the Trial and that my address details are correct. Name Date of birth Today's date Signature Address and Post Code Contact Telephone Number NHS Number GP Details 5. In addition, I AGREE to my HPV sample being retained for future research. This will be stored anonymously. I understand that if I do not agree my sample will be destroyed as the end of the research study. Name Date of birth Today's date Signature Name of patient: Name of Clinician: Hospital: Please initial box 1. I confirm that I have read and understand the information sheet dated 27/02/04 (version 4.4) for the above study and have had the opportunity to ask questions. 2. I understand that my participation is voluntary and that I am free to withdraw at any time, without giving any reason, without my medical care or legal rights being affected. 3. I understand that sections of any of my medical notes may be looked at by responsible individuals from the PRIME team or from regulatory authorities where it is relevant to my taking part in research. I give permission for these individuals to have access to my records. 4. I agree to my General Practitioner being informed of my taking part in this research and of any clinically significant information that arises. 5. I agree to take part in the above study. (Signature on this form does not affect your legal rights). Researcher’s signature: Date: I hereby freely give my consent to take part in this study. Patient’s signature: Date: Witness to written consent Name: Signature: Relationship to patient: Date: Consent Form (OPTIMA prelim) Patient Consent Form: Consent to Participate in OPTIMA prelim Optima prelim Optimal Personalised Treatment of early breast cancer using Multi parameter Analysis Study Doctor Name: Study Site: Patient Information Sheet Version No.: Version Date: Patient statement and signature Please initial the boxes below if you agree Initials 1. I have read and received a copy of the OPTIMA prelim Patient Information Sheet. I fully understand what is involved in taking part in this study and have had an opportunity to ask questions, and all of my questions have been answered. 2. I understand that my participation is entirely voluntary and that I am free to withdraw from the study at any time without giving a reason and without my medical care or legal rights being affected. 3. I understand that the researchers in charge of the study may stop the study at any time without my consent if it is believed it is in the best interest of study participants. 4. I give my permission for the OPTIMA Trial Office and other sites undertaking OPTIMA research to hold information about me. I understand that this will not include details of my identity unless I give separate permission for this. 5. I understand that data collected for this study is covered by the Data Protection Act (1998) and all electronic data will be stored in a secure format. 6. I understand that relevant sections of my medical notes and data collected during the study may be looked at by responsible individuals from the Clinical Trials Unit () and/or other authorised representatives from the University of and (the Sponsors of the study), from regulatory authorities or from the NHS Trust, where it is relevant to my taking part in this research. I give permission for these individuals to have access to my records which will identify me by name. 7. I understand that I will not be identified in any reports or publications resulting from the study. 8. I give my permission for a letter and information about OPTIMA prelim to be sent to my General Practitioner, which will tell him/her that I have decided to take part in the study. 9. I understand that samples of my cancer removed at the time of surgery will be used for research as part of the OPTIMA study. 10. I understand that some of this research may generate information that companies may use in future for commercial gain. 11. I agree to complete questionnaires regarding the impact of the treatment and my quality of life. 12. OPTIONAL: I give my permission for the OPTIMA Trial Office to hold a record of my personal details. I understand that this includes my date of birth, name and address which will be used for tracking my tumour sample and for follow up with the Office of National Statistics. All data which will identify me by name will be kept on a secure database and only used for the above purpose. 13. OPTIONAL: I agree to donate the remainder of my samples for future research projects. I understand that donating samples is a gift for this research, that it is entirely voluntary and that I am free to withdraw my approval for use of the samples at any time without giving a reason and that my medical treatment or legal rights will not be affected by this voluntary donation. 14. OPTIONAL: I am willing to be contacted by an OPTIMA researcher to discuss my reasons for joining the study. 15. I voluntarily agree to participate in this study. Your signature confirms that you have had an opportunity to ask questions and that all of your questions have been answered. (You will be given a signed and dated copy of this consent form to take away with you) Patient signature: Name (print): Date signed: Investigator Statement and Signature. To be completed by the investigator or designee taking consent I have discussed this clinical research study with the patient and/or his or her authorised representative using a language that is understandable and appropriate. I believe that I have fully informed the participant of the nature of this study and the possible benefits and risks of taking part. I believe the participant has understood this explanation. Signature: Name (print): Date signed: CONSENT FORM Strategies to Increase Cervical Screening Uptake at First Invitation (STRATEGIC) 1. I confirm that I have read and understood the trained nurse patient information sheet dated 07/02/13 (version 4) for the above study. 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, without my medical care or legal rights being affected. 3. I understand that my details will be stored on the trial database to allow the researchers to check the national cervical screening database to see if I attend for cytology screening as a result of speaking to the trained nurse. 4. I understand that relevant sections of my cervical screening history and data collected during the study may be looked at by individuals from the University of , from regulatory authorities or from the NHS Trust, where it is relevant to my taking part in this research. I give permission for these individuals to have access to my cervical screening records. 5. I agree to take part in the above study. 6. I agree to the trained nurse contacting me in the future (please provide your contact details below). Name Date of birth Phone Number Mobile Number Email Address The BOSS study (Barrett’s Oesophagus Surveillance Study) Title: A randomised controlled trial of surveillance for patients with Barrett’s oesophagus Study Doctor Name: Study Site: Patient Name: Trial No.*: *To be completed following notification from the Trial Office upon randomisation Patient Statement and Signature To be completed by the patient Please initial the boxes below if you agree. 1. I have read and received a copy of the BOSS Patient Information Sheet (version or, dated) and I fully understand what is involved in taking part in this trial and have had an opportunity to ask questions, and all of my questions have been answered. 2. I understand that my participation is voluntary and that I am free to withdraw from the study at any time without giving a reason, without my medical care or other legal rights being affected 3. I give my permission for information held by the NHS and records maintained by the Office of National Statistics to be used to keep in touch with me and follow up my health status. 4. I also understand that sections of any of my medical notes may be looked at by responsible individuals from the BOSS Trial Office ( Hospitals NHS Foundation Trust - sponsor) and regulatory agencies where it is relevant to my taking part in this research study. I give permission for these individuals to have access to my records that identify me by name. 5. I understand that I will not be identified in any reports or publications resulting from the study. Yes No 6. I give my permission for a letter and information about the BOSS study to be sent to my GP, which tells them that I have decided to take part in the study. My signature confirms that I have had an opportunity to ask questions, and all of my questions have been answered. I freely agree to participate in this study. Signature Name (print): Date Signed: You will be given a signed and dated copy of this consent form to take away with you. Investigator Statement and Signature To be completed by the person taking consent I have discussed this clinical research study with the patient and/or his or her authorised representative, using a language that is understandable and appropriate. I believe that I have fully informed the participant of the nature of this study and its possible benefits and risks and I believe the participant understood this explanation. Signature Name (print): Date Signed: Consent form Virtual colonoscopy compared with conventional colonoscopy for diagnosis of bowel disease Please initial box 1. I confirm that I have read and understand the information sheet dated May 2005 for the above study and have had the opportunity to ask questions. 2. I understand that my participation is voluntary and that I am free to withdraw at any time, without giving any reason, without my medical care or legal rights being affected. 3. I understand that sections of any of my medical notes may be looked at by responsible individuals from regulatory authorities where it is relevant to my taking part in research. I give permission for these individuals to have access to my records. I understand that data collected in this trial may be used for future research and that I cannot be identified from this data. 4. In principle I agree to take part in the above study. I understand that this decision is not binding at this point in time and that I have at least 24 hours further to reconsider. Name of Patient Date Signature Name of researcher or person taking consent (if different from researcher) Date Signature Thank you. Please return in the stamped, addressed envelope provided to: . SIGGAR1 Trial, CRIB Cardiac Rehabilitation in Bowel Cancer CANCER PATIENT CONSENT FORM PLEASE INITIAL BOX IF YOU AGREE 1. I confirm that I have read and understand the information sheet (version 2 18Feb 2013) for this study and have had the opportunity to ask questions 2. I understand that if I participate in an interview it may be audio recorded 3. I understand that my participation is voluntary and that I am free to withdraw at any time, without giving any reason 4. I understand that the research team will hold the information I give confidentially and my name will not be mentioned in any reports 5. I understand that all information from this study will be kept in a locked filing cabinet at the University of and stored in a password protected folder on the University computer hard drive 6. I understand that if consent to participate in the study is declined or terminated at any stage, I will enter normal post treatment follow up care 7. If I withdraw from the study at any time, I consent to the retention of data collected up to the point of my withdrawal 8. I agree to a letter being sent to my GP informing them that I am involved in this study 9. I agree to participate in this study Name of Participant Signature Date Name of Witness (Research Team Member) Signature Date REGISTRATION CONSENT FORM For the FOCUS4 Trials Programme in colorectal cancer Centre name and number: ……………………………………………………………… Patient Registration ID number: ……………………………………………………………… Please initial boxes: 1. I confirm that I have read and understand the Patient Information Sheet 1 - consent step 1 (Version 1.0, February 2013) for the above research study and have been given a copy to keep. I have had the opportunity to ask questions and am satisfied with the answers to my questions. 2. I understand that sections of any of my medical notes may be looked at by individuals from organisations involved in developing and running the trial (e.g. ), or from regulatory authorities where it is relevant to my taking part in this research. I give permission for these individuals to have access to my records, but understand my confidentiality will be maintained. 3. I give permission for a sample of my stored tumour to be sent for specific tests at the central laboratory as required for FOCUS4. 4. I give permission for a copy of my consent form to be sent to the local pathology department (where it will be kept in a secure location), to authorise the release of my pathology block and to the where once checked, the consent form will be destroyed. 5. I understand that my participation is voluntary and that I am free to withdraw at any time, without giving any reason, without my medical care or legal rights being affected. 6. I agree to take part in the above research study. For the following questions (7- 9) if you do not wish to give this permission, please tick the “No” box – you can still participate in the main research. 7. I give permission for my name to be registered with the Office of National Statistics (ONS) or traced via the NHS Strategic Tracing Service should I lose contact with my hospital doctor. I give permission for information about my health status to be obtained from the ONS and/or the NHS Strategic Tracing Service by the Medical Research Council if necessary. 8. I give permission to take blood samples including the DNA to be used for future bowel cancer research. 9. I give permission for my stored pathological material to be used for future bowel cancer research. Name of Patient Date Signature Researcher Date Signature Name of Person taking consent Date Signature (if different from researcher) Title of Project: CONVERT (Concurrent Once daily VErsus twice daily RadioTherapy) A 2-arm randomised controlled trial of concurrent chemo radiotherapy comparing twice daily and once daily radiotherapy schedules in patients with limited stage small cell lung cancer (SCLC) and good performance status Name of the researcher: Please initial box 1. I confirm that I have read and understand the information sheet dated 10JUN2008 (version 3.0) for the above study. I have had the opportunity to consider the information, ask questions and 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, without my medical care or legal rights being affected. 3. I understand that relevant sections of my medical notes and data collected during the study may be looked at by individuals from regulatory authorities or authorised study personnel, where it is relevant to my taking part in this research. I give permission for these individuals to have access to my records. 4. I agree to my GP being informed of my participation in the study and of any clinically significant information that arises. 5. I agree to take part in the above study. 6. I agree to give for this project: - tissue samples YES / NO (delete as applicable) - blood samples YES / NO (delete as applicable) I understand how the sample(s) will be collected, that gifting samples for this research is voluntary and that I am free to withdraw my approval for use of the samples at any time without giving a reason and without my medical treatment or legal rights being affected. 7. I agree that any sample(s) I have gifted, and anonymous information gathered about me, can be stored at the for possible use in future projects, as described in the information sheet. I understand that some of these projects may be carried out by researchers other than the CONVERT research team, including researchers working for commercial companies and elsewhere within and outside the European Union (EU). I consent to export of anonymised data and tissue samples within and outside the EU, and to the use of the samples for future, ethically approved, research. 8. I understand that I will not benefit financially if this research leads to the development of a new treatment or medical test. 9. I understand that the planned and future research using any sample(s) I have gifted may include genetic research aimed at understanding the genetic influences on lung cancer, but that the results of these investigations are unlikely to have any implications for me personally. Name of Patient Date Signature Name of Person taking consent (if different from researcher) Date Signature Researcher Date Signature