We help you convert Discovery and Topic Framing outputs into a structured study design and protocol. Expect PICO or PECO framed questions, sampling and randomization logic, SOP and visit schedules, CRF or EDC shells, quality control and deviation handling notes, and clean statistical linkages that make ethics, departmental, and reviewer scrutiny easier.

• PICO or PECO framing of the primary question and comparisons
• Mapping of aims and hypotheses to design type and overall structure
• High level study flow diagram from screening to analysis population
• Consistency checks with Discovery and Topic Framing section outputs
• Reviewer friendly synopsis paragraph around PICO or PECO wording
• Ready to paste problem and design and flow block for protocol and ethics forms

• Target population and sampling frame expressed in simple language
• Sampling approach justification with basic bias and feasibility notes
• Randomization or allocation method description where applicable
• Allocation concealment and sequence handling notes at PhD scale
• Recruitment and screening flow snapshot including ineligible and refusal handling
• Text aligned with common protocol and ethics committee templates

• Primary and secondary endpoints clearly described with timepoints where needed
• Lists of exposure, outcome, confounder, and other covariate variables
• Operational and diagnostic or case definitions aligned with accepted guidance
• Measurement scales, units, instruments, and basic scoring rules
• Schedule of assessments table linking visits or timepoints to measures
• Traceability from endpoints and variables to planned statistical approaches

• High level visit or contact schedule with objectives for each visit
• Outline SOP or lab manual content for critical procedures and sample handling
• Suggested checklists for pre visit, during visit, and post visit steps
• Basic responsibility matrix so tasks are clear for guides and site teams
• Alignment of visit schedule with endpoints and data collection windows
• Language that can be adapted into institutional SOP and departmental manuals

• Draft CRF or EDC shells aligned with visits and variables
• Field level data dictionary with labels, permitted values, and basic checks
• Segregation of identifiers and analysis variables to support de identification
• Notes on derived variables and codes needed for later analysis
• Cross checks between CRF or EDC, SOPs, and visit schedules
• Simple formats that work well in spreadsheets or straightforward EDC tools

• Selection of key quality indicators such as recruitment, completeness, and adherence
• Simple monitoring plan describing checks, frequency, and responsible person
• Templates for logs that track screening, enrolment, data queries, and corrections
• Deviation categorisation framework for minor and major protocol deviations
• Escalation and correction pathways that are feasible for individual scholars
• Protocol ready wording for QC and deviation sections in ethics and approvals

• Clarification of the primary effect or comparison that drives sample size inputs
• Outcome type mapping to basic tests or models to be used
• List of parameters needed for power or sample size calculations
• Draft analysis shell structure tying endpoints to planned analyses
• Flags for interim, subgroup, or sensitivity analyses where relevant
• Bridging text so that design, data structure, and statistics read as one narrative