Trials

Run the study from one record

flowchart LR
    Scattered[Scattered study context] --> Trial[Trial record]
    Trial --> Design[Design and start-up decisions]
    Trial --> Context[Connected operational context]
    Trial --> Governance[Governed review and history]

Teams rarely fail because they have no study data. They fail because study context is scattered across documents, spreadsheets, and memory with no single governing anchor.

A trial record gives the team one durable place to answer questions such as:

• what is this study, who is it for, and what does it measure
• which organizations, sites, contacts, and interventions participate
• what eligibility criteria, endpoints, and objectives define the scientific structure
• whether changes to the study are traceable and reviewable

That matters because almost every other record in TrialStack — organizations, sites, contacts, interventions, personas, media, systems — becomes operationally meaningful only once it is connected back to the trial it supports.

Keep context connected

flowchart LR
    Trial[Trial] --> Orgs[Organizations]
    Trial --> Sites[Sites]
    Trial --> Contacts[Contacts]
    Trial --> Interventions[Interventions]
    Trial --> Personas[Personas]
    Trial --> Systems[Systems]
    Trial --> Media[Media]
    Trial --> Modules[Specialized modules]
    Modules --> Workflows[Design, review, and start-up workflows]

TrialStack treats the main trial record and the specialized trial workflow modules as related but different surfaces.

• the main trial record holds the cross-study description, classification, criteria, objectives, outcomes, identifiers, and all entity relationships
• the specialized modules hold deeper operational work such as design, approval, monitoring, recruitment, retention, safety, schedule, engagement, and statistical detail

That split matters because teams can keep one clear study anchor without forcing every trial-facing workflow into one overloaded form. The main record is the study-wide spine; the modules are where discipline-specific work deepens.

Teams usually get the most value from the trial record when they need to make cross-cutting study decisions, not when they are producing background documentation.

The page is especially useful when a team needs to:

• establish the foundational study identity before connecting sites, contacts, and interventions
• define the eligibility framework — indications, inclusion, and exclusion criteria
• structure the scientific measurement model — endpoints, objectives, estimands, outcomes
• frame the risk–benefit justification and treatment context
• maintain governance across changes with full version history, compare, and restore

Trials also connect in both directions. A team can start from the trial and connect relevant entities, or start from an organization, site, or intervention and link back to the study it supports.

On the page

The trial page is section-based rather than flat. It is built around fifteen governed sections, with specialized modules and relationship tabs alongside.

Surface	Purpose	What users do there
Summary	Maintain the study-wide description and structure	Capture identity, classification, criteria, endpoints, objectives, estimands, outcomes, identifiers
Trial modules	Hold deeper operational work by discipline	Move into design, approval, monitoring, recruitment, retention, safety, schedule, statistical, engagement
Relationship tabs	Keep operational context visible	Review linked organizations, sites, contacts, interventions, personas, systems, media, documents, evidence packs

Most teams use the page in a rhythm like this:

1. Create the trial record and establish the study identity.
2. Define eligibility criteria, endpoints, and objectives.
3. Connect organizations, sites, contacts, interventions, and personas.
4. Move into specialized modules as planning and execution deepen.
5. Review history, compare versions, or restore earlier states when the change path matters.

flowchart TD
    Page[Trial page] --> Summary[Summary sections]
    Page --> Modules[Trial modules]
    Page --> Relationships[Relationship tabs]
    Summary --> Core[Identity, criteria, objectives, outcomes]
    Modules --> Discipline[Design, approval, monitoring, recruitment, retention, safety, schedule, statistical, engagement]
    Relationships --> Context[Organizations, sites, contacts, interventions, personas, systems, media, documents, evidence packs]

A strong trial record is not just a protocol paraphrase. It gives the team a governed study anchor they can actually make cross-cutting decisions with.

Good trial records usually do six things well:

• they establish a clear study identity with title, protocol number, phase, and design classification
• they define eligibility criteria that are specific enough to be operationally useful
• they structure the scientific measurement model so endpoints, objectives, and estimands remain explicit
• they keep the risk–benefit justification visible and connected to treatment context
• they connect every relevant entity — org, site, contact, intervention, persona, system — so operational context is never orphaned
• they preserve a traceable change history because trial modifications have downstream impact

That is why only Title is required. The point is not to force completion of every section. The point is to capture the information that supports real downstream decisions.

Review, history, and other governed behavior are covered in the Workflows section and apply here in the same way they do across the rest of the governed record model. All fifteen sections support verification status tracking.

Overview

This section establishes the foundational study identity. It is the first thing reviewers see and the anchor for every downstream section.

Label	Description	Type
Title	The primary study title that identifies this trial across the system	Text
Protocol Number	Formal protocol identifier used for regulatory submissions and cross-system reference	Text
Responsible Party Type	Who holds responsibility for registration and reporting	Select
Study Type	Whether the study is interventional, observational, or another design category	Select
Phase	Clinical development phase that frames the study scope	Select
Primary Purpose	The main scientific objective — treatment, prevention, diagnostic, or other	Select
Interventional Study Model	Design structure such as parallel, crossover, single group, or factorial	Select
Control Type	What the study compares against — placebo, active comparator, dose-comparison, or other	Select
Enrollment Count	Target number of participants the study plans to enroll	Number
Masking	Whether the study uses single-blind, double-blind, open-label, or other masking approaches	Select
Masked Roles	Which roles are masked — participant, investigator, outcome assessor, care provider	Multi-select
Therapeutic Areas	Disease or therapy categories the study addresses	Multi-select
Synopsis	High-level study summary intended for quick orientation	Rich text
Background and Rationale	Scientific and operational rationale that justifies the study	Rich text

Risks

This section captures the known potential risks that should remain visible as part of the risk–benefit justification.

Label	Description	Type
Category	Risk classification such as medical, procedural, or psychological	Select (badge)
Title	Short identifier for the risk	Text
Description	Detailed explanation of the risk and its context	Rich text

Benefits

This section captures the known potential benefits that balance the risk profile.

Label	Description	Type
Category	Benefit classification such as therapeutic, diagnostic, or quality-of-life	Select (badge)
Title	Short identifier for the benefit	Text
Description	Detailed explanation of the benefit and expected impact	Rich text

Reference Therapies

Reference therapies frame the treatment context by identifying comparator treatments, standard-of-care references, or rescue medications.

Label	Description	Type
Linked Intervention	Optional link to an intervention record for cross-referencing	Combobox
Therapy Type	Whether the therapy serves as comparator, rescue, standard-of-care, or other	Select (badge)
Rationale for Selection	Why this therapy was chosen as a comparator or reference	Rich text
Dose Rationale	Justification for the dosing regimen	Rich text
Frequency	How often the reference therapy is administered	Text
Duration	Length of the reference therapy period	Text
Supply Source	Where the reference therapy is sourced	Select
Notes	Additional context about the reference therapy	Rich text

Medication Restrictions

Medication restrictions define which medications participants must avoid and under what conditions.

Label	Description	Type
Name	Medication or therapy name	Text
Category	Restriction classification such as prohibited, conditional, or washout-required	Select (badge)
Washout Period	Required washout duration before study participation	Text
Rationale	Why this restriction exists and its scientific justification	Rich text

Indications

Indications identify the medical conditions or disease areas the study targets.

Label	Description	Type
Name	Indication or condition name	Text
Is Primary	Whether this is the primary or secondary indication	Toggle
Description	Additional context about the indication and its relevance	Rich text

Inclusion Criteria

Inclusion criteria define who is eligible to enter the study.

Label	Description	Type
Text	The full inclusion criterion statement	Rich text

Exclusion Criteria

Exclusion criteria define who should not be enrolled in the study.

Label	Description	Type
Text	The full exclusion criterion statement	Rich text

Endpoints

Endpoints define the specific measurements the study uses to evaluate outcomes.

Label	Description	Type
Title	Name of the endpoint	Text
Level	Whether primary, secondary, or exploratory — filterable across the table	Select (badge)
Data Type	Nature of the measurement such as continuous, binary, time-to-event, or categorical	Select (badge)
Description	Detailed specification of what the endpoint measures and how	Rich text

Objectives

Objectives state the scientific questions the study is designed to answer.

Label	Description	Type
Name	Short objective title	Text
Level	Whether primary, secondary, or exploratory — filterable across the table	Select (badge)
Description	Full objective statement with context	Rich text

Estimands

Estimands define the treatment effect the study intends to estimate, following ICH E9(R1) guidance.

Label	Description	Type
Name	Short estimand title	Text
Level	Whether primary, secondary, or exploratory — filterable across the table	Select (badge)
Description	Full estimand definition including population, variable, intercurrent events, and summary measure	Rich text

Discontinuation Criteria

Discontinuation criteria define the conditions under which a participant or the study itself may be stopped.

Label	Description	Type
Title	Short name for the discontinuation criterion	Text
Scope	Whether the criterion applies at participant or study level	Select (badge)
Category	Classification such as safety, futility, efficacy, or administrative	Select (badge)
Estimand Strategy	How this intercurrent event is handled in the estimand framework	Select
Is Mandatory	Whether discontinuation is required or discretionary when the criterion is met	Toggle
Description	Full explanation of the criterion and its operational implications	Rich text

Subject Replacement Rules

Replacement rules define how and when participants who discontinue can be replaced to maintain study power.

Label	Description	Type
Title	Short name for the replacement rule	Text
Trigger Criterion	Which discontinuation criteria activate this replacement rule — cross-references the Discontinuation Criteria section	Multi-select
Replacement Window Value	How long the replacement window stays open	Number
Replacement Window Unit	Time unit for the replacement window	Select
Max Replacements	Upper limit on how many replacements are allowed under this rule	Number
Description	Full explanation of the replacement logic and any constraints	Rich text

Outcome Measures

Outcome measures define registry-facing measurements used for reporting and compliance.

Label	Description	Type
Title	Name of the outcome measure	Text
Type	Whether primary, secondary, or other	Select (badge)
Time Frame Value	Measurement window duration	Number
Time Frame Unit	Time unit for the measurement window	Select
Description	Full specification of what is measured and how	Rich text

Secondary Identifiers

Secondary identifiers capture external reference numbers used for cross-system tracking and regulatory submissions.

Label	Description	Type
Identifier	The external identifier value	Text
Type	Kind of identifier such as registry, regulatory, or internal	Select (badge)
Domain	Which system or domain the identifier belongs to	Select (badge)