Table 1 Acceptance checklist for clinical effectiveness pilot trials (ACCEPT): trial components, exemplar monitoring methods and exemplar outcomes

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