Documentation/Clinical Trials & Research

Module guide · Clinical

Clinical Trials & Research

From registering a study to enrolling participants, reporting safety events, and collecting visit data, with the regulatory deadlines tracked for you.

Overview Dashboard Trial registry Trial detail Enrollment Adverse events Data collection Glossary Good practices

What this module is for

Everything a research team needs to run a clinical study inside the hospital's own systems, tied to real patient records, instead of a separate spreadsheet-and-paper workflow.

Who uses it

Research coordinators run the day-to-day work, enrollment, visits, safety reports. Principal Investigators (PIs) and compliance/safety officers oversee trials and review the regulatory deadlines this module tracks automatically.

Where to find it

Open Research from the sidebar. A dashboard plus five tools, forms open in a slide-out panel rather than a new page.

1
Dashboard
Every trial's health at a glance, enrollment, safety, IRB expiry, funding.
2
Trial Registry
Register a new study and manage the roster of all trials.
3
Trial Detail
One study's control panel, overview, participants, safety events, exports.
4
Enrollment
Sign patients up, track them through screening to treatment, schedule visits.
5
Adverse Events
Report safety events and manage the FDA reporting clock.
6
Data Collection
Enter visit data (eCRFs) and log biological samples.

Research Dashboard

A bird's-eye view of every trial's enrollment, safety, and compliance status, and the hub to the rest of the module.

Top stat tiles

Field	What it means
Active Trials / Recruiting	Trials currently running, and how many are actively signing up new participants.
Participants Enrolled / Active Subjects	Total ever enrolled across all trials, and how many are still on-study right now.
Serious Adverse Events / Unreported SAEs	Total SAEs recorded, and how many are still waiting on the required FDA report (see the 7/15-day rule below).
IRB Expiring (30d)	Trials whose ethics-board approval lapses within 30 days.
Open Data Queries	Data-entry forms with an unresolved question or correction request pending.

Enrollment Overview

Screen failures (people who didn't qualify), Withdrawals, and the average enrollment rate per month.

Biospecimens & Funding

Specimens collected/available/expired, plus active grants, total active funding, and publications produced from trial data.

A Compliance & Safety Alerts list flags overdue safety reports and expiring approvals, tagged CRITICAL (red) or WARNING (amber). A Recent Serious Adverse Events table gives a quick safety feed when any exist.

Trial Registry

The master list of every study, register a new one here and search/filter the existing roster.

List columns

Field	What it means
Trial	Brief title, with its NCT number and acronym underneath.
Phase	Early Phase 1 through Phase 4, or N/A, see the glossary for what each phase means.
Status	Colored badge, see the legend below.
Sponsor / PI	The funding organization, and the Principal Investigator running it locally.
Enrollment	Current participants / target, e.g. "12 / 40."
IRB Expiry	When ethics approval lapses, shown in red/bold if already expired.

Field	What it means
NCT Number*	The study's ClinicalTrials.gov ID, "NCT" plus 8 digits. Locked once the trial exists.
Title / Brief Title*	Full official title, and a shorter plain-language version.
Phase, Study Type*	Interventional (participants receive the tested treatment), Observational (researchers just watch, no assigned treatment), Observational Registry, or Expanded Access (compassionate use).
Sponsor, PI, IRB*	Who's funding it, who's running it locally (with NPI/email/phone), and the ethics committee's approval number and date.
Start Date, Target Enrollment*	When the trial began, and how many participants it aims to recruit.
ICD-10 Code	The diagnosis this trial targets, e.g. a specific cancer code.
Brief Summary	Free-text paragraph describing the study.

Export downloads a FHIR R4 bundle (a standardized health-data file) for that trial. Clicking a trial row opens Trial Detail.

Recruiting — actively enrolling

Active, Not Recruiting — running, not taking new participants

Not Yet Recruiting — approved, not yet open

Suspended — temporarily paused

Terminated / Withdrawn — stopped, before or after enrolling

Completed — finished

Trial Detail

One study's control panel: overview, its participants, its adverse events, and export options, all in one place.

IRB expiry banner

If ethics approval has lapsed, a red banner appears: "IRB approval has expired. Enrollment and study activities may need to pause per 45 CFR 46" (the U.S. federal rule governing human-subjects research).

Tabs

Field	What it means
Overview	Sponsor & Investigator details, IRB & Timeline dates, and the brief summary.
Enrollment	A preview of active participants, subject ID, treatment arm, status, AE/SAE counts. "Manage Enrollment" jumps to the full screen.
Adverse Events	A preview of recent events, grade, whether it's an SAE, dates. "Manage AEs" jumps to the full screen.
Exports	Five one-click downloads: a FHIR R4 study bundle, an enrollment list (CSV), an SAE/AE report formatted for the FDA's MedWatch form, a biospecimen manifest, and a publications list.

Changing the trial's status

The status dropdown in the header updates immediately for most changes. Picking Terminated, Suspended, or Withdrawn prompts for a reason, the change is cancelled if you leave it blank.

Trial Enrollment

Sign patients up, move them through screening, consent, enrollment, and randomization, and manage their visit schedule.

"Enroll Participant" form

Field	What it means
Trial, Patient*	The study, and the real hospital patient record, found by name or MRN search.
Subject ID*	The study-specific code assigned to this participant, kept separate from their MRN for privacy/blinding.
Screen Date*	When the participant was screened for eligibility.
Consent Date, Consent Version	When informed consent was signed, and which version of the consent document was used, tracked because consent forms get revised as protocols change.
Screen Fail Reason	Free text, if the participant didn't qualify.

Roster actions

Field	What it means
Status dropdown	Changing to Withdrawn, Screen Failed, AE Withdrawal, Protocol Deviation, or Lost to Follow-Up prompts for a reason, important for the audit trail.
Randomize	Assigns the participant to a treatment arm and, optionally, a randomization number, via two prompts.
Visit	Schedules the next study visit date.

Screened / Consented — passed eligibility / signed consent

Enrolled / Randomized — formally in the study / assigned a treatment arm

On Treatment / Completed — receiving treatment / finished per protocol

Withdrawn / Lost to Follow-Up — left voluntarily / can no longer be reached

Screen Failed / AE Withdrawal — didn't qualify / removed due to a safety event

Adverse Events

Report and track anything unwanted that happens to a participant, and manage the regulatory reporting clock to the FDA.

The FDA reporting clock

21 CFR 312.32 requires notifying the FDA within 7 calendar days for the most urgent events (deaths, life-threatening events, and SUSARs) and within 15 days for other serious events. A red banner counts down any unreported SAEs.

Report Adverse Event (key fields)

Field	What it means
Participant, Event Term*	Which enrolled participant, and what happened (ideally using the standard MedDRA medical vocabulary).
CTCAE Grade*	Grade 1 (Mild) through Grade 5 (Death), the standard severity scale.
Attribution*	How likely the study treatment caused it: Unrelated, Unlikely, Possible, Probable, Definite, or Not Assessable.
"This is a Serious Adverse Event"	Checking it reveals seriousness criteria to confirm: Death, Life-threatening, Hospitalization, Persistent disability, Birth defect, or another important medical event.
Expected / SUSAR checkboxes	Whether the event was already known from the protocol, and whether it's a SUSAR, Suspected Unexpected Serious Adverse Reaction, serious, likely drug-related, AND not previously known. SUSARs get the fastest, 7-day, reporting clock.
Onset Date, Reported Date, Reported By*	When it started, when it was logged, and who's reporting it, pre-filled with your name.
Narrative	Free-text description of what happened.

Record FDA Notice logs the date you notified the FDA and stops the countdown clock for that event.

Grade 1 · Mild — gray

Grade 2 · Moderate — light blue

Grade 3 · Severe — amber

Grade 4 · Life-Threatening — red

Grade 5 · Death — dark red, row highlighted

Data Collection

Where visit data gets entered (eCRFs) and biological samples get logged.

eCRF Forms tab

Participant, Form Name, Visit Name, and the actual collected values (entered as structured JSON text, a technical field with no field-by-field UI). Verify (SDV) records that a monitor cross-checked the data against source records. Complete & Sign finalizes a form. Raise Query / Resolve Query flag or clear a data question.

Biospecimens tab

Barcode, Specimen Type (blood, plasma, urine, tissue, and many more), Collection Date/Site, physical details (volume, weight, aliquots), and Storage Condition (room temperature through liquid nitrogen). Status shows red "Expired" once past its expiry date, green "Available" while usable.

Quick glossary

The regulatory shorthand used throughout this module, in plain terms.

Field	What it means
NCT Number	The public ID a trial gets when registered on ClinicalTrials.gov.
IRB	Institutional Review Board, the local ethics committee that approves and re-approves a trial to protect participants.
Informed Consent	The process ensuring a participant understands and agrees to the risks/benefits before joining.
Randomization	Assigning participants to a treatment group through a controlled process to reduce bias.
SAE	Serious Adverse Event, one meeting specific severity criteria (death, hospitalization, disability, and others) that triggers mandatory fast reporting.
SUSAR	A Suspected Unexpected Serious Adverse Reaction, serious, likely drug-related, and not previously known, the most urgent reporting category.
SDV	Source Data Verification, an independent check that entered data matches the original medical record.
eCRF	Electronic Case Report Form, the digital form used to record what happened at each study visit.
Biospecimen	Any biological sample (blood, tissue, saliva, etc.) collected for research or lab analysis.

Good practices

Don't let the FDA clock run out

Record the FDA notification date as soon as you've actually called it in, the Dashboard's Unreported SAEs tile and the Adverse Events banner both exist to keep this from being missed.

Track the consent version

Protocols get amended, consent forms get revised to match. Recording which version a participant signed matters if the protocol changes later.

IRB expiry pauses the study, not just the paperwork

Federal regulation (45 CFR 46) means an expired IRB approval can require pausing enrollment and study activities, not just a compliance reminder, renew before the 30-day warning window closes.

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