Table 1.

Acceptance checklist for clinical effectiveness pilot trials (ACCEPT): trial components, exemplar monitoring methods and exemplar outcomes

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