Study protocol

Study protocol

Now that the research question has been decided, and it has been checked that su ffi cient patients should be available to enrol into the study , it is time to prepare the detail of the trial. At this stage, a study protocol should be constructed to define the research plan. It should contain the background of the definitions of population and sample sizes and methods of proposed analysis. It should include the patient numbers, inclusion and e xclusion criteria and the timescale for the work. The protocol should be detailed enough for another party to come along in the future and theoretically replicate the study . that a It is useful to construct a flow diagram giving a clear summary - of the research protocol and its requirements ( Figure 13.1 ). It is helpful to imagine the paper that will be written about the study before the study is performed. This may prevent errors in data collection. When a study is planned, su ffi cient time should be r eserved at the beginning for fund-raising and obtaining ethical, regula - tory and or other approvals (e.g. HRA). Time for data analysis and preparation of publication needs to be included in fund - ing applications. The cost of any non-routine investiga tions and extra treatments should be identified and covered by the - research grant in line with national guidance (in the UK, the er Attributing the costs of health and social care Resear ch and Development [AcoRD] guidance; https://www .gov .uk/gov - ernment/publications/guidance-on-attributing-the-costs-of - health-and-social-care-research). A data collection form should be designed or a computer collection package developed. If data are collected on a com - - puter, appropriate safeguards for privacy , confidentiality and data quality will be necessary to comply with legislation. At this stage it is important to consider any validation require - - ments and needs for open access, either in a recognised archive (e.g. the UK Data Archive) or in an institutional repository . Any form of data collection needs to be quality assured. The quality assurance process will include training, standard oper - ating procedures as w ell as monitoring and checking a certain sample of the data. At the end of data collection and analysis, a final database with all data should be locked and kept for future reference in a safe location. A da ta-archiving policy with a nominated data custodian should be in place. Research is no longer confined by institutional or even geo - graphical boundaries. Collaborative research groups in sur - gery at a national or international level have come together to undertake high-quality surgical research in recent years, aided by online communication and the a vailability of secure elec - tronic databases such as REDCap™. The SUNRRISE trial shown in Figure 13.1 was undertaken by researchers from two trainee-led research collaborative g roups across the UK, in conjunction with a parallel collaborative group in Australia. All patients were included within the same study cohort in real time: the Australian sites were e ff ectively identical to those in the UK because of online electronic randomisation systems and online live data capture via REDCap. Some publishers require registration of a study at the time it is set up on a publicly available database (e.g. the World Health Organization’s recognised registries suc h as ISRCTN, EudraCT and ClinicalTrials.gov). It is becoming increasingly popular to consider publication of a protocol paper. Study protocol

Now that the research question has been decided, and it has been checked that su ffi cient patients should be available to enrol into the study , it is time to prepare the detail of the trial. At this stage, a study protocol should be constructed to define the research plan. It should contain the background of the definitions of population and sample sizes and methods of proposed analysis. It should include the patient numbers, inclusion and e xclusion criteria and the timescale for the work. The protocol should be detailed enough for another party to come along in the future and theoretically replicate the study . that a It is useful to construct a flow diagram giving a clear summary - of the research protocol and its requirements ( Figure 13.1 ). It is helpful to imagine the paper that will be written about the study before the study is performed. This may prevent errors in data collection. When a study is planned, su ffi cient time should be r eserved at the beginning for fund-raising and obtaining ethical, regula - tory and or other approvals (e.g. HRA). Time for data analysis and preparation of publication needs to be included in fund - ing applications. The cost of any non-routine investiga tions and extra treatments should be identified and covered by the - research grant in line with national guidance (in the UK, the er Attributing the costs of health and social care Resear ch and Development [AcoRD] guidance; https://www .gov .uk/gov - ernment/publications/guidance-on-attributing-the-costs-of - health-and-social-care-research). A data collection form should be designed or a computer collection package developed. If data are collected on a com - - puter, appropriate safeguards for privacy , confidentiality and data quality will be necessary to comply with legislation. At this stage it is important to consider any validation require - - ments and needs for open access, either in a recognised archive (e.g. the UK Data Archive) or in an institutional repository . Any form of data collection needs to be quality assured. The quality assurance process will include training, standard oper - ating procedures as w ell as monitoring and checking a certain sample of the data. At the end of data collection and analysis, a final database with all data should be locked and kept for future reference in a safe location. A da ta-archiving policy with a nominated data custodian should be in place. Research is no longer confined by institutional or even geo - graphical boundaries. Collaborative research groups in sur - gery at a national or international level have come together to undertake high-quality surgical research in recent years, aided by online communication and the a vailability of secure elec - tronic databases such as REDCap™. The SUNRRISE trial shown in Figure 13.1 was undertaken by researchers from two trainee-led research collaborative g roups across the UK, in conjunction with a parallel collaborative group in Australia. All patients were included within the same study cohort in real time: the Australian sites were e ff ectively identical to those in the UK because of online electronic randomisation systems and online live data capture via REDCap. Some publishers require registration of a study at the time it is set up on a publicly available database (e.g. the World Health Organization’s recognised registries suc h as ISRCTN, EudraCT and ClinicalTrials.gov). It is becoming increasingly popular to consider publication of a protocol paper. Study protocol

Now that the research question has been decided, and it has been checked that su ffi cient patients should be available to enrol into the study , it is time to prepare the detail of the trial. At this stage, a study protocol should be constructed to define the research plan. It should contain the background of the definitions of population and sample sizes and methods of proposed analysis. It should include the patient numbers, inclusion and e xclusion criteria and the timescale for the work. The protocol should be detailed enough for another party to come along in the future and theoretically replicate the study . that a It is useful to construct a flow diagram giving a clear summary - of the research protocol and its requirements ( Figure 13.1 ). It is helpful to imagine the paper that will be written about the study before the study is performed. This may prevent errors in data collection. When a study is planned, su ffi cient time should be r eserved at the beginning for fund-raising and obtaining ethical, regula - tory and or other approvals (e.g. HRA). Time for data analysis and preparation of publication needs to be included in fund - ing applications. The cost of any non-routine investiga tions and extra treatments should be identified and covered by the - research grant in line with national guidance (in the UK, the er Attributing the costs of health and social care Resear ch and Development [AcoRD] guidance; https://www .gov .uk/gov - ernment/publications/guidance-on-attributing-the-costs-of - health-and-social-care-research). A data collection form should be designed or a computer collection package developed. If data are collected on a com - - puter, appropriate safeguards for privacy , confidentiality and data quality will be necessary to comply with legislation. At this stage it is important to consider any validation require - - ments and needs for open access, either in a recognised archive (e.g. the UK Data Archive) or in an institutional repository . Any form of data collection needs to be quality assured. The quality assurance process will include training, standard oper - ating procedures as w ell as monitoring and checking a certain sample of the data. At the end of data collection and analysis, a final database with all data should be locked and kept for future reference in a safe location. A da ta-archiving policy with a nominated data custodian should be in place. Research is no longer confined by institutional or even geo - graphical boundaries. Collaborative research groups in sur - gery at a national or international level have come together to undertake high-quality surgical research in recent years, aided by online communication and the a vailability of secure elec - tronic databases such as REDCap™. The SUNRRISE trial shown in Figure 13.1 was undertaken by researchers from two trainee-led research collaborative g roups across the UK, in conjunction with a parallel collaborative group in Australia. All patients were included within the same study cohort in real time: the Australian sites were e ff ectively identical to those in the UK because of online electronic randomisation systems and online live data capture via REDCap. Some publishers require registration of a study at the time it is set up on a publicly available database (e.g. the World Health Organization’s recognised registries suc h as ISRCTN, EudraCT and ClinicalTrials.gov). It is becoming increasingly popular to consider publication of a protocol paper.