Section I: Basic content Sample Clauses

Section I: Basic content. The first section of the Fieldwork Manual can be structured e.g. in 7 main points that comprise the essential topics to address when conducting fieldwork (see Table 1 above). The first topic (Background and Benefits) gives an overview of the study in the scope of the HBM4EU programme, provides details on the objectives and benefits on different levels (individual, public health and research) and elaborates on the thematic areas covered within the study. Point 2 provides details on the design of the actual study, the target population, and the recruitment of individuals to achieve the desired amount of participants. Inclusion and exclusion criteria as well as the definition of a case, i.e. which data needs to be collected from a participant to involve him or her in the final data file, are to be described in detail here. Ethics requirements are of utmost importance and an ethics approval is the essential prerequisite for a study including the collection of human data and samples. Therefore, it is appropriate to address these issues in a separate point (point 3). It includes detailed information on how (potential) participants are informed about the study, asked for informed consent, how they can revoke from the participation and if this has implications on them. Measures that have been taken to ensure data protection and accordance with ethics requirements are also described. The approvals of ethics and data protection authorities are mentioned. The HBM4EU deliverables D1.5 ‘Legal and Ethics Policy paper’ and D10.1 ‘Data Management Plan’ including its annex should be read carefully and taken into account for point 3. Before details of fieldwork are described, the management of the study is laid down under point 4 to inform about responsibilities for the different tasks. This is especially important if parts of study conduct are subcontracted. It also includes the responsibility and timing of training for the field staff. The time schedule for fieldwork and routes, survey methods and all instruments (like questionnaires and samples) used as well as a detailed plan of procedure and information on quality assurance are elaborated on under point 5, Fieldwork. Single steps from first contact to fixing an appointment with the participant including all communication material, all details of involvement of the participants including e.g. furnishing of examination centres, provision of incentives and documentation of procedures like questionnaires and sampling are d...
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