Trial design
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Review research protocol especially balance of scientific & practical needs
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Yes/No
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Amend trial design & dependent components. Submit amendment to Research Ethics Committee
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Sample size
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Test assumptions within protocol on: number of (active) centres; recruitment rates; retention rates; & SD of primary outcomes
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Yes/No
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Revise if necessary: sample size calculation; trial period; & funding
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Interventions
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Clinical governance
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Assess compliance with: formal training in intervention; Health & Safety regulations; & other clinical governance requirements
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Yes/No
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Enhance formal training of intervention providers
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Intervention fidelity
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Measure & assess adherence to intervention manual by video, observation or audio
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Yes/No
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Enhance clinical supervision of intervention providers
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Participants
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Recruitment strategy
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Assess: flows of participants; cost & productivity of each route
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Yes/No
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Refine recruitment strategy, generally & locally
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Eligibility criteria
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Assess: characteristics of sample; barriers to recruitment; update of intervention
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Yes/No
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Refine eligibility criteria
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Consent procedures
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Participant Information Sheets (PIS)
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Consult participants & refusers
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Yes/No
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Refine PIS especially to address frequently asked questions
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Taking informed consent
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Audit consent documentation. Measure & assess adherence to consent procedures by video, observation or audio
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Yes/No
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Enhance training of research team
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Randomisation process
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Check quality especially: accessibility by researchers; validity of CONSORT flowchart; & accuracy of stratifying variables
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Yes/No
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Refine: randomisation procedure & parameters; & training of research team
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Blinding
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Check whether assessors can predict individual allocations. Test whether unblinded researchers can keep other researchers blind
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Yes/No
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Refine blinding procedures, e.g. by reallocating responsibilities within research team
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Data
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Data collection
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Assess adherence to interview schedules & fieldwork handbook, including duration of assessments, by video, observation or audio
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Yes/No
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Refine schedules to reduce assessment burden. Enhance training of research team
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Data quality
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Test missing data procedures within draft analysis plan
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Yes/No
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Refine data collection tools & missing data procedures
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Data management
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Test trial database, related procedures & link to analytical software
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Yes/No
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Refine trial database & procedures
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Research Governance
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Research protocol adherence
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Enable quality assurance officer (QAO) to test adherence as widely as possible
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Yes/No
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Refine: protocol; quality assurance plan & training of team
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Adverse events (AE)
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QAO to test procedures for: reporting AEs; assessing severity, causality & expectedness monitor at management group; report to DMEC
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Yes/No
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Refine AE reporting & assessment procedures
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Health & Safety
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Test H&S procedures, e.g. for lone working
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Yes/No
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Refine H&S procedures
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Data analysis
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Test draft analysis plan on pilot data
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Yes/No
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Refine analysis plan to address research aims in full
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Trial management |
Review role descriptions of research team. Review remits of trial management group, trial research team etc. |
Yes/No |
Review role descriptions of research team. Refine roles e.g. if workloads vary. Refine remits e.g. if inadequate reporting of any component |