Consent and ethics setup

Before a study can enroll anyone, participants need to understand what they are agreeing to, and your team needs its ethics oversight and safety definitions in place. The Safety & Consent tab of the Study Builder is where you configure the participant-facing consent content, the study's IRB information, and the definitions that safety monitoring runs on. A companion Regulatory tab captures the study's reporting regime.

Together these tabs are configuration, not paperwork filing: what you enter here is what participants read at enrollment, and what drives the study's safety and reporting workflows later on.

eConsent content#

eConsent (electronic informed consent — the digital equivalent of the paper consent form) is what a prospective participant reads and agrees to in the app before enrolling. It is organized into content blocks:

• Overview and procedures — what the study is about and what participation involves.
• Risks and benefits — what a participant might gain and what could go wrong.
• Compensation — what, if anything, participants receive for taking part.
• Data use after withdrawal — whether data collected before a participant withdraws may continue to be used.

Write these blocks in plain language. The population TrialPilot serves often reads with fatigue and brain fog, and consent that is not understood is not truly informed. Rehearsing the consent flow in test mode is the fastest way to find confusing passages before a real participant does.

How participants experience consent#

Before enrollment, the app shows the consent screen built from your content blocks. The participant reads it and chooses whether to enroll. Consent is recorded online at the moment it is given — if the participant's connection drops, the app asks them to reconnect before enrolling rather than silently saving the consent for later. There is never a window where a participant believes they consented but no record exists.

Central IRB and ethics information#

An IRB (Institutional Review Board, called an ethics committee or IEC in many countries) is the independent body that reviews and approves research involving human participants. The Safety & Consent tab records the study's central IRB details:

Central IRB name

The IRB or ethics committee overseeing the study.

IRB protocol number

The identifier the IRB assigned to this protocol.

Approval status

Where the protocol stands with the IRB — for example approved or pending.

Approval date

When the IRB approved the protocol.

Expiration date

When the current approval expires and continuing review is due.

sIRB reliance agreement

Whether sites rely on a single IRB (sIRB) under a reliance agreement rather than each obtaining separate local review.

For studies that opt into the enrollment activation gate, ongoing IRB submissions, amendments, and reportable events are managed in the Regulatory workspace after the study is built.

Safety definitions#

Safety monitoring needs shared definitions before the study starts: what counts as an adverse event, what makes one serious, and who watches the accumulating data. The Safety & Consent tab captures:

• Solicited adverse events — the specific events the study actively asks participants about.
• Unsolicited adverse events — how the study handles events participants report on their own.
• SAE definition — what qualifies as a serious adverse event for this study.
• Data Safety Monitoring Board information — details of the DSMB, the independent group that reviews safety data while the study runs, when one exists.

These definitions feed the day-to-day safety workflows — escalations, triage, and adverse event management — described in Safety operations.

The Regulatory profile tab#

The Regulatory tab inside the Study Builder configures the study's reporting regime — the regulatory posture that determines what must be reported, to whom, and how fast:

Regulatory type

The regulatory category the study falls under, which shapes its reporting obligations.

Sponsor-investigator IIT setting

Whether this is an investigator-initiated trial (IIT) where the investigator also acts as sponsor.

IND number

The Investigational New Drug application number, for drug studies conducted under an IND.

IDE number

The Investigational Device Exemption number, for device studies conducted under an IDE.

IND-exemption rationale

The documented reasoning when the study proceeds without an IND.

Investigator’s Brochure version

The version of the Investigator’s Brochure (the compiled clinical and nonclinical information about the product) the study operates under.

Investigator-to-sponsor reporting window

How quickly investigators must report qualifying events to the sponsor.

Red-flag rules

The rules that mark incoming reports as needing urgent attention.

With consent, ethics, and the regulatory profile in place, the remaining Study Builder work is design-dependent: randomization and blinding for randomized designs, then publish and recruit.