End of the study Your participation in the study stops when you have completed all the visits [according to the schedule/as described under point 4] you choose to stop you become pregnant <if applicable> <and if applicable:> the end of the entire study has been reached <if applicable; if the study continues until an endpoint has been reached, this should be explained here, for example, a specific number of cases of X> the investigator considers it best for you to stop [name of company], the government or Medical Research Ethics Committee, decides to stop the study. The study is concluded once all the participants have completed the study. <if the participants are patients and this concerns a medicinal product medication you have used during the study [will/will not] be available once the study has ended. The investigator will discuss the options for further medical care with you. After processing the data, the investigator will inform you about the most important results of the study. <if known, and it can be indicated in general> This will happen about [timeframe] after your participation. The investigator will also tell you treatment you had/which group you were in, <if applicable>]. If you do not want this to happen, please tell the investigator. He/she will then not be permitted to tell you. and storage of your data [and bodily material] For this study it is necessary to collect and use your [bodily material and] your medical and personal data. Each study subject will receive a code that will be marked on [the bodily material and] the data. Your name and other personal data will be deleted. Your data All your data will remain confidential. The investigator [and [is/are] the only …] [person/people] who will know which code you have. <if applicable> We will share your data with the sponsor of the study, but only using that code, never using your name. The key to the code will stay with the investigator. In the reports about the study only use this code will be used. Some people may access your medical and personal data. This is to check whether the study has been conducted in a good and reliable manner. General information about this can be found in the general brochure on medical research. People who may access your data are <give a full list, select as appropriate>: the study
End of the study Your participation in the study stops when you have completed all the visits [according to the schedule/as described under point 4] you choose to stop you become pregnant <if applicable> <and if applicable:> the end of the entire study has been reached <if applicable; if the study continues until an endpoint has been reached, this should be explained here, for example, a specific number of cases of X> the investigator considers it best for you to stop [name of company], the government or Medical Research Ethics Committee, decides to stop the study. The study is concluded once all the participants have completed the study. <if the participants are patients and this concerns a medicinal product medication you have used during the study [will/will not] be available once the study has ended. The investigator will discuss the options for further medical care with you. After processing the data, the investigator will inform you about the most important results of the study. <if known, and it can be indicated in general> This will happen about [timeframe] after your participation. The investigator will also tell you treatment you had/which group you were in, <if applicable>]. If you do not want this to happen, please tell the investigator. He/she will then not be permitted to tell you. and storage of your data [and bodily material] For this study it is necessary to collect and use your [bodily material and] your medical and personal data. Each study subject will receive a code that will be marked on [the bodily material and] the data. Your name and other personal data will be deleted. Your data All your data will remain confidential. The investigator [and …] [is/are] the only [person/people] who will know which code you have. <if applicable> We will share your data with the sponsor of the study, but only using that code, never using your name. The key to the code will stay with the investigator. In the reports about the study only use this code will be used. Some people may access your medical and personal data. This is to check whether the study has been conducted in a good and reliable manner. General information about this can be found in the general brochure on medical research. People who may access your data are <give a full list, select as appropriate>: the study
Model-PIF-voor-DCTF-site_versie-juli-2016-Engels..docx