A study template is a curated, versioned starting point for a new study. Instead of facing a blank Study Builder, you pick the design that matches your research question and get a fully-configured draft: design settings, durations, objectives, endpoints, a validated instrument battery with schedules, sample-size defaults, eligibility criteria, and a written statistical-methods plan — all editable.
Templates are shipped and curated by TrialPilot, not user-authored. Their defaults reflect the design mainstream Long COVID trials have converged on, parameterized for related conditions such as ME/CFS, POTS, and Lyme. Post-exertional malaise measurement (DSQ-PEM) is on by default in every template. You can also skip templates entirely and start from a blank Custom setup.
The four templates#
| Template | Design | What it sets up |
|---|---|---|
| Placebo-Controlled Trial | Randomized, double-blind, placebo-controlled, 1:1 | The rigorous RCT for interventional trials where the study provides the drug. PROMIS-29 Physical Health as the primary endpoint with a mixed-model (MMRM) analysis plan, a 14-day wearable baseline, a daily symptom diary, a follow-up battery at Day 15 and Weeks 4, 10, and 15, home-feasible performance tests, and a default of 100 participants (50 per arm). |
| Observational Study | Prospective observational cohort, open label, no control | Real-world evidence where participants bring their own intervention and each serves as their own control. Pre-post primary readout (PROMIS-29 Physical Health at Month 3), monthly then quarterly follow-up, weekly functional-status tracking, home-feasible objective tests only, and a default of 500 participants. |
| N-of-1 Self-Trial | Single-subject randomized multi-crossover (ABAB / BABA), single blind | Rigorous personal experiments run as a series: four 4-week phases with washouts scaffolded into the dosing schedule, randomized phase order, daily target-symptom tracking, and a Bayesian pooled-analysis plan across a default series of 20 participants. |
| Single-Timepoint Study | Cross-sectional, one contribution per participant | One specimen or one survey: a bounded questionnaire battery targeted at under thirty minutes plus an optional mailed specimen, with specimen-lifecycle configuration in place of a schedule. No cadence, no baseline period, no wearable — deliberately. |
The first three templates are recurring: a participant enrolls and keeps showing up on a schedule. The Single-Timepoint Study is bounded: the participant contributes once and is finished. That participation shape is surfaced on the template chooser because it is the property that most changes what participants experience — and it is not a lighter version of the recurring designs, but a different one, built around a specimen lifecycle and a completion funnel instead of adherence.
Match the shape, then the design
What a template pre-fills — and what it leaves to you#
Pre-filled by the template#
- Study design: design type, blinding, control type, randomization ratio, and participation shape.
- Durations: total study duration, per-participant duration, and wearable baseline days.
- Objectives and endpoints: primary, secondary, exploratory, and safety objectives, written out in full.
- Sample-size defaults and inclusion and exclusion criteria.
- The instrument battery with per-instrument schedules (baseline, daily, weekly, or specific study weeks).
- A statistical-methods write-up matched to the design, including its known limitations and recommended mitigations.
- Comparator and, where the design calls for it, dose-phase scaffolding, SAE definition, and DSMB defaults.
- For the Single-Timepoint Study, the specimen configuration: specimen type, lab certification, collection window, and kit counts inflated for expected non-return.
Still yours to configure#
Templates never touch researcher-identity fields: study titles, sponsor, study team, regulatory identifiers, and IRB details stay yours. You also still name the actual intervention and dosing for interventional designs, complete consent and ethics setup, and work through the normal Study Builder review before publishing. Every pre-filled value is an editable default, not a constraint.
Versioning and customization tracking#
Templates are versioned semantically (for example 1.0.0), and design refinements ship as new versions — existing versions are never edited. A study records which template and which version it was created from, and it keeps that version: a later template revision never silently changes an existing study.
The Study Builder shows the study's template as a chip in its header. Because the template's defaults are defined in the platform itself, TrialPilot can compute — at read time, with no bookkeeping to drift — exactly which template-managed fields you have customized away from the defaults, including instruments you added or removed and schedules you changed. Identity fields you were always expected to fill in never count as customizations.
Switching templates#
While a study is in draft, you can switch it to a different template or to a custom setup:
- Switching to another template resets the template-managed fields and applies the new template's defaults — design, durations, objectives, criteria, the assessment schedule, and statistical methods — while leaving researcher-identity fields untouched.
- Switching to Custom clears the template reference but keeps your current configuration as-is.
Draft only
Instrument library and licensing#
The instruments templates draw on come from a curated library. Each instrument carries metadata to help you choose well: measured domains, recall period, Long COVID validation status, recommended cadences, template compatibility, and usage warnings — for example, exertional tests warn that they can provoke post-exertional malaise and should be paired with a PEM check-in 24 to 48 hours afterwards.
Some instruments are not free to use. Where an instrument's license requires registration or a fee — for example, instruments that are free for non-commercial use but charge commercial studies a per-study or per-administration fee — the library shows the cost notes, and adding the instrument to a study is gated behind an explicit confirmation that you have arranged the license. TrialPilot does not obtain instrument licenses on your behalf.
Next: continue in Build a study to review what the template filled in, then fine-tune the battery in Assessments and schedules.