Design

The researcher has to decide on the best way to answer the research question such as if existing data will be used or whether new data needs to be collected (such as from questionnaires or during a research visit). If the latter, then clinical protocols and / or questionnaires need to be selected or designed as well as deciding who will be in the study (with regard to age, sex, zygosity etc). The method by which the data will be analysed also needs to be considered. The number of personnel working on the study will need to be decided as well as the teams required for support and processing (eg statisticians, research nurses, admin, lab), as well as budget and timelines. Before the study can be proceed further, the researcher must apply for ethics approval to ensure participant’s safety and apply for funding to cover all the costs of carrying out the study.