The following will take place: We will do a physical examination - at two visits We will make a heart tracing (ECG) - at one visit We will draw - at each visit, two tubes each time + what it is for (do not list all analyses, but, for example. This is to see how well […] is absorbed in your blood/We will measure […]/to check for [side effects/…]). We will ask you to complete a questionnaire about […] - at each visit Appendix C describes what will take place during each visit. OR You will be telephoned at home [X] times. You will then be asked about […]. A telephone call will take [...]. OR You will be sent a questionnaire [X] times. The questions are about […]. Completing the questionnaire will take you about [X minutes]. END OF EXAMPLE PASSAGE EXAMPLE PASSAGE Other than standard care Usually you may perhaps only visit your doctor for follow-up for [disorder] once every two months. Your doctor [will then take 1 tube of blood/will examine your /will make The … …]. study-related visits will replace these regular visits to your doctor/are additional. END OF EXAMPLE PASSAGE What is expected of you In order to carry out the study properly [<if applicable> and for your own safety], it is important that you follow the study instructions. The instructions require that you: <delete or supplement as appropriate, see guidance in the comment>: [take the study product/do the exercises] as directed. do not participate in another medical study. keep appointments for visits. carry your participant card for the study with you. This card states that you are participating in this study. It also states whom to contact in the event of an emergency. Show this card if you visit any [other] doctor. It is important that you contact the investigator: <delete as appropriate> before you start using other medicines. Even if they are homeopathic or natural remedies, vitamins and/or over-the-counter medicines. if you are admitted to hospital or are for treatment there. if you suddenly develop any health problems. if you no longer want to participate in the study. if your contact details change. EXAMPLE PASSAGE Pregnancy<Include as appropriate - split into text for women and text for men if appropriate> Your or your partner’s pregnancy
The following will take place: We will do a physical examination - at two visits We will make a heart tracing (ECG) - at one visit We will draw - at each visit, two tubes each time + what it is for (do not list all analyses, but, for example. This is to see how well […] is absorbed in your blood/We will measure […]/to check for [side effects/…]). We will ask you to complete a questionnaire about […] - at each visit Appendix C describes what will take place during each visit. OR You will be telephoned at home [X] times. You will then be asked about […]. A telephone call will take [...]. OR You will be sent a questionnaire [X] times. The questions are about […]. Completing the questionnaire will take you about [X minutes]. END OF EXAMPLE PASSAGE EXAMPLE PASSAGE Other than standard care Usually you may perhaps only visit your doctor for follow-up for [disorder] once every two months. Your doctor [will then take 1 tube of blood/will examine your … /will make …]. The study-related visits will replace these regular visits to your doctor/are additional. END OF EXAMPLE PASSAGE What is expected of you In order to carry out the study properly [<if applicable> and for your own safety], it is important that you follow the study instructions. The instructions require that you: <delete or supplement as appropriate, see guidance in the comment>: [take the study product/do the exercises] as directed. do not participate in another medical study. keep appointments for visits. carry your participant card for the study with you. This card states that you are participating in this study. It also states whom to contact in the event of an emergency. Show this card if you visit any [other] doctor. It is important that you contact the investigator: <delete as appropriate> before you start using other medicines. Even if they are homeopathic or natural remedies, vitamins and/or over-the-counter medicines. if you are admitted to hospital or are for treatment there. if you suddenly develop any health problems. if you no longer want to participate in the study. if your contact details change. EXAMPLE PASSAGE Pregnancy<Include as appropriate - split into text for women and text for men if appropriate> Your or your partner’s pregnancy
Model-PIF-voor-DCTF-site_versie-juli-2016-Engels..docx