some concepts. Key concepts, such as voluntary participation, withdrawal, data handling and insurance should all be covered in the information sheet (see this template). of view, length and language level Consistent with the objective of the PIS: write from the point of view of the study subject (not the investigator). Make sure that the information sheet is concise and easy to read. This may require specialist input from e.g. a professional editor, instructor or communication specialist. Ask a lay person preferably educated to no more than basic secondary education level to proofread your text. The subject information sheet must not be longer than 1500/2500 words. This word count does not include the consent form(s) and the following appendices: contact details, insurance text, schematic overview of study procedures and, for example, more information about side effects or mechanism of action of the product or treatment under investigation. The appendices, like the rest of the PIS, should be concise and easy to read. The language level of the information sheet should be no higher than basic secondary education level. The standard and example passages in this template meet this requirement (tested by Readability Foundation [Stichting Makkelijk Lezen]). Exceptions include a target audience very different from the ordinary Dutch population (e.g. children under 12, students in further education). This template was supported by and developed in collaboration with Nefarma, NFU, STZ, V&VN Research Professionals, ACRON, de Hart&Vaatgroep, Insurance Alliance, NVMETC and the Ministry of Health, Welfare and Sport. Please use the feedback form on the DCTF website to report any inconsistencies or give other feedback. The general brochure on medical research can be found on the CCMO website or you can order one free of charge from the government, call 1400 or visit . Subject information for participation in medical scientific research [Title of the study] Official title: Introduction Dear <Always>You are asked to take part in a medical-scientific study. Participation is voluntary. Participation requires your written consent. <if the patient was invited because of a specific disease or procedure or recent diagnosis>You have received this letter because you have [disorder]/have been diagnosed with [syndrome]/you will shortly undergo [procedure].
some concepts. Key concepts, such as voluntary participation, withdrawal, data handling and insurance should all be covered in the information sheet (see this template). of view, length and language level Consistent with the objective of the PIS: write from the point of view of the study subject (not the investigator). Make sure that the information sheet is concise and easy to read. This may require specialist input from e.g. a professional editor, instructor or communication specialist. Ask a lay person preferably educated to no more than basic secondary education level to proofread your text. The subject information sheet must not be longer than 1500/2500 words. This word count does not include the consent form(s) and the following appendices: contact details, insurance text, schematic overview of study procedures and, for example, more information about side effects or mechanism of action of the product or treatment under investigation. The appendices, like the rest of the PIS, should be concise and easy to read. The language level of the information sheet should be no higher than basic secondary education level. The standard and example passages in this template meet this requirement (tested by Readability Foundation [Stichting Makkelijk Lezen]). Exceptions include a target audience very different from the ordinary Dutch population (e.g. children under 12, students in further education). This template was supported by and developed in collaboration with Nefarma, NFU, STZ, V&VN Research Professionals, ACRON, de Hart&Vaatgroep, Insurance Alliance, NVMETC and the Ministry of Health, Welfare and Sport. Please use the feedback form on the DCTF website to report any inconsistencies or give other feedback. The general brochure on medical research can be found on the CCMO website or you can order one free of charge from the government, call 1400 or visit . Subject information for participation in medical scientific research [Title of the study] Official title: Introduction Dear <Always>You are asked to take part in a medical-scientific study. Participation is voluntary. Participation requires your written consent. <if the patient was invited because of a specific disease or procedure or recent diagnosis>You have received this letter because you have [disorder]/have been diagnosed with [syndrome]/you will shortly undergo [procedure].
Model-PIF-voor-DCTF-site_versie-juli-2016-Engels..docx