Building a trial with Scorch

Scorch, Trialflare's built-in AI assistant, can set up a new trial for you from your study's documents and a description. Instead of creating the trial, writing its details in, configuring consent and building each form by hand, you hand Scorch what you already have — a protocol, a participant information sheet, a consent form, your questionnaires — and it builds a first version of the trial for you to finish.

The trial builder is a team feature. If your team has it, it appears as a Trial builder tab when you create a new trial. If it doesn't, ask your account manager.

What you give it

When you create a new trial, choose the Trial builder tab. There are two things to fill in, and either on its own is enough to start from:

  • Describe your trial. Anything Scorch should know that your documents don't say, or everything, if you have no documents to hand: the study's name, what it is testing, which forms you need and when they are completed, whether participants give consent. A paragraph is plenty. For example:

    A 12-week study of a sleep-support app in adults with insomnia. Participants complete a baseline questionnaire, a daily sleep diary and the PHQ-9 at weeks 0, 6 and 12. Participants give informed consent.

  • Documents. Up to 15 files of up to 4.5 MB each, as PDF, Word, Excel, CSV, text, Markdown or HTML. The most useful are:

    • your protocol, for the trial's details, its eligibility criteria and its schedule of assessments;
    • your participant information sheet and informed consent form, for the consent setup;
    • questionnaires and instruments, each of which becomes a stage with its questions and response options as written.

Where your description and your documents disagree, your description wins.

Click Build my trial. Scorch reads each document, works out how the trial should be set up, and then builds it. The page tells you what it is doing at each step; a build with several documents takes a few minutes, and you can stay on the page while it works.

What it builds

The trial. Its name and description, plus the scientific name, acronym, sponsor and protocol number where a document states them. Scorch doesn't invent these: anything it can't find is left blank.

Consent, if your study takes it. If your description or any document mentions informed consent, a consent form or an information sheet, Scorch switches on eConsent and creates a consent form with:

  • the eligibility criteria — inclusion and exclusion — found in your protocol or information sheet, for participants to confirm;
  • the conditions participants tick to confirm ("I confirm that I have read the information sheet…"), taken from your consent form as written;
  • your participant information sheet, transcribed from the document you uploaded (or from the consent form, if that is what you uploaded) as the text participants read — with a note in the report to read it through, since a transcription of a long document is worth checking;
  • a placeholder privacy statement, clearly marked, for you to replace — see what it leaves for you.

If nothing mentions consent, no consent form is created. If your team doesn't have eConsent, the consent form is skipped and the report says so.

A stage for each form. One for every questionnaire in your documents, every visit or assessment in your schedule that collects data, and every form your description asks for. A questionnaire from your documents is reproduced with its questions and response options in order; a form described in words is built from the description, with branching where a question only applies in certain circumstances, just as generating stages from a description does.

Each stage also gets its schedule where the documents or description say what it is:

  • who completes it — a diary or questionnaire the participant fills in is made available to participants; a case report form or visit assessment completed by the study team is not;
  • how it repeats — "daily for two weeks", "weekly for 12 weeks", or a visit schedule like "weeks 0, 6 and 12", with each occurrence named;
  • when it opens, if it becomes available a number of days after another form is completed;
  • whether it is ad hoc, for something reported whenever it happens, such as an adverse event.

A stage participants complete on a schedule also gets a morning and an afternoon push reminder, which you can edit or remove like any other. Anything not stated is left at the defaults, exactly as a stage you created yourself would be. The table in Generating stages from a description shows which phrases become which settings.

The build report

When Scorch finishes, it shows you a report before taking you to the trial:

  • Documents read — each file, and what Scorch took it to be (protocol, information sheet, consent form, questionnaire). A file it couldn't read is marked as such and wasn't used.
  • Trial — the name, and which details were also filled in.
  • Consent — whether eConsent was set up, how many conditions the form has, and whether eligibility criteria were found.
  • Stages — each planned stage, whether it was built, the schedule it was given, and any notes: a field type that had to be changed, a branch that couldn't be built.
  • Left for you — the things Scorch couldn't do or could only do with a placeholder.

Go to trial takes you to the new trial. The report isn't kept, so if you want to keep a note of it, take it before you close it.

What it leaves for you

Scorch builds a first version; it is not a finished trial. Before inviting anyone, go through what it left for you, which the report lists and which will usually include:

  • The privacy statement. eConsent is switched on with a placeholder statement so that the consent form could be set up. Replace it under About in your study settings before anyone consents.
  • The information sheet. Read the transcribed sheet through under Consent > Informed consent forms and tidy anything the copy got wrong. If no sheet was uploaded, or it couldn't be transcribed, the form's body is a placeholder telling you to paste it in.
  • Conditions or eligibility criteria that weren't found. If no consent form was uploaded the consent form has no conditions; if no criteria were found it has no eligibility section. Add them on the same page.
  • Stages that couldn't be built, or that were built with a note against them. Check each stage in Stages, in particular the field types and any branching.
  • Anything not stated. Sites, groups, participants, anchors, automatic messages and integrations are yours to set up as usual.

Everything Scorch builds is an ordinary trial, consent form and set of stages: you can change any of it in the same places you would if you'd created it yourself.

Tips

  • A description alone works. If you have no documents, describe the study, its forms and who completes them when, and Scorch builds from that. It builds the forms it is told about rather than guessing at ones it isn't.
  • Ask for a draft information sheet if you need one. Scorch never invents an information sheet, but if you say "write a sample participant information sheet" it will draft one from what it knows about the study, with "[to be confirmed]" where it lacks the detail and a banner saying it is a draft. An uploaded sheet is always used in preference to a drafted one.
  • Say when things happen. "Weekly for 12 weeks", "the day after the baseline visit", "whenever a participant has a side effect" — each becomes a schedule setting. A form whose timing isn't stated is created without one.
  • If a document can't be read, the report says so. The build carries on without it, so check the Documents read section if something you expected is missing from the trial.
  • You can run it more than once. Each build creates a new trial, so if the first attempt isn't right, delete it from the trial's settings and build again with a clearer description or a different set of documents.
  • It counts as a trial. A built trial counts towards your team's trial limit, like one created any other way.