<if this concerns an authorised product> More information [medicine] can be found in the package leaflet, see appendix [X]OR Are you participating in the study? You will then receive the package leaflet with the medicine. <optional, if there are many side effects, or if this requires a significant amount of explanation or possibly with very rare side effects> can find more information in Appendix [X] …..You [Comparator]<if applicable> The [comparator] may also cause side effects. The most important ones are: <list the most important/most likely side effects> More information about the [comparator] can be found in the package leaflet, see Appendix [X]OR Are you participating in the study? You will then receive the package leaflet with the medicine. Tests <Describe the possible adverse effects and discomforts of the invasive procedures that will be performed as part of the study - also remember exposure to radiation, for example> EXAMPLE PASSAGE Drawing blood may be painful or cause some bruising. In total, we will take [XX ml] of blood from <if a rather large amount of blood is being taken:> you. This amount does not cause any problems in [adults]. To compare: a blood donation involves 500 ml of blood being taken each time. END OF EXAMPLE PASSAGE EXAMPLE PASSAGE Exposure to radiation [Select test: CT scan, PET, ...] involves using [X-rays and/or radioactive markers]. The total amount of radiation you will be exposed to in this study is [XX] mSv. To compare: the background radiation in the Netherlands is ~2.5 mSv per year. If you participate in scientific research involving exposure to radiation more you should discuss with the investigator whether participation now would be safe. The radiation used during the study may lead to damage to your health. However, this risk is small. We nevertheless advise you not to participate in another scientific study involving exposure to radiation in the near future. Examinations or procedures involving radiation for medical reasons are not a problem. END OF EXAMPLE PASSAGE Possible advantages and disadvantages <Always>It is important that you properly weigh up the possible benefits and disadvantages before you decide to join. Situation Example text (benefit) No benefit to healthy subject You will not personally benefit from participation in this study. Your participation may contribute to increased knowledge about [the treatment of [disease/disorder]/the activity of/...].
<if this concerns an authorised product> More information [medicine] can be found in the package leaflet, see appendix [X]OR Are you participating in the study? You will then receive the package leaflet with the medicine. <optional, if there are many side effects, or if this requires a significant amount of explanation or possibly with very rare side effects> …..You can find more information in Appendix [X] [Comparator]<if applicable> The [comparator] may also cause side effects. The most important ones are: <list the most important/most likely side effects> More information about the [comparator] can be found in the package leaflet, see Appendix [X]OR Are you participating in the study? You will then receive the package leaflet with the medicine. Tests <Describe the possible adverse effects and discomforts of the invasive procedures that will be performed as part of the study - also remember exposure to radiation, for example> EXAMPLE PASSAGE Drawing blood may be painful or cause some bruising. <if a rather large amount of blood is being taken:> In total, we will take [XX ml] of blood from you. This amount does not cause any problems in [adults]. To compare: a blood donation involves 500 ml of blood being taken each time. END OF EXAMPLE PASSAGE EXAMPLE PASSAGE Exposure to radiation [Select test: CT scan, PET, ...] involves using [X-rays and/or radioactive markers]. The total amount of radiation you will be exposed to in this study is [XX] mSv. To compare: the background radiation in the Netherlands is ~2.5 mSv per year. If you participate in scientific research involving exposure to radiation more you should discuss with the investigator whether participation now would be safe. The radiation used during the study may lead to damage to your health. However, this risk is small. We nevertheless advise you not to participate in another scientific study involving exposure to radiation in the near future. Examinations or procedures involving radiation for medical reasons are not a problem. END OF EXAMPLE PASSAGE Possible advantages and disadvantages <Always>It is important that you properly weigh up the possible benefits and disadvantages before you decide to join. Situation Example text (benefit) No benefit to healthy subject You will not personally benefit from participation in this study. Your participation may contribute to increased knowledge about [the treatment of [disease/disorder]/the activity of/...].