IBD programs are built as induction then maintenance, often with responders re-randomized, and judged on endoscopy plus diary data. Capture handles the periods, the scoring components and the safety screening in one study. This page is the disease-specific view; the wider GI page covers diaries in general.
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Participants due Week 12 visit
18
With at least 3 valid diary days
15
At risk
3
Endoscopy reads pending
4
All complete
2 missing days
1 missing day
What Crohn’s and UC trials need from an EDC
Study design
A typical IBD program starts with a placebo-controlled induction period of around 8 to 12 weeks. Participants who respond may then enter a maintenance period, often re-randomized to continue the drug or switch to placebo, and everyone may roll into a long-term extension. For the data system that means three things. The schedule has several epochs with different visit patterns. Baseline for the maintenance endpoint is usually the end of induction, not the original baseline. And a response determination at the end of induction drives an allocation, so that determination has to be accurate, fast and attributable.
In ulcerative colitis, the commonly used modified Mayo score combines stool frequency and rectal bleeding from the participant’s diary with an endoscopic subscore from a centrally read endoscopy. In Crohn’s disease, protocols commonly pair a clinical measure (the CDAI, or patient-reported stool frequency and abdominal pain) with an endoscopic score such as SES-CD. Secondary summaries of the FDA’s April 2022 draft guidances for both diseases describe co-primary clinical and endoscopic remission; check the current text of the guidance and your regulator’s advice before fixing definitions in a protocol. What matters for the EDC is that each component is stored as its own typed variable with its own date, so the derived score can be reproduced by a statistician and challenged by an auditor.
Crohn’s disease adds disease behaviours that ulcerative colitis does not. Perianal fistulizing disease has its own endpoints (fistula drainage on examination, closure, sometimes MRI findings), and small-bowel disease may need imaging rather than colonoscopy. If your protocol includes a fistula cohort, build a dedicated form for the examination findings rather than reusing the luminal one. For participants’ day-to-day reporting, the same diary and reminder mechanics described on the gastroenterology and IBD page apply; this page concentrates on the periods, the safety screening and the data traceability that are specific to the two diseases.
| Assessment | Screen | BL | W4 | W8 | W12 (end induction) | W24 | W52 |
|---|---|---|---|---|---|---|---|
| Daily diary: stool, bleeding or pain | D | D | D | D | D | D | D |
| Endoscopy, local and central read | |||||||
| Response check and re-randomization | |||||||
| CRP, calprotectin, safety labs | |||||||
| Infection screening (TB, hepatitis B, stool) |
D = daily diary entries in the days before the visit
Endpoint components
| Disease | Measure | Components to capture | Source |
|---|---|---|---|
| Ulcerative colitis | Modified Mayo score | Stool frequency vs baseline normal, rectal bleeding, endoscopic subscore | Diary and central endoscopy read |
| Ulcerative colitis | Histology | Biopsy site, scoring system used, score | Central or local pathology |
| Crohn’s disease | CDAI | Seven days of stool count, pain and well-being, extra-intestinal items, medication, mass, hematocrit, weight | Diary plus visit form |
| Crohn’s disease | PRO2 | Stool frequency and abdominal pain, daily | Diary |
| Crohn’s disease | SES-CD | Ulcer size, ulcerated and affected surface, narrowing, by segment | Central endoscopy read |
| Both | Biomarkers | CRP, fecal calprotectin with assay, sample date | Lab form |
Instruments named for structure only; wording and licensing sit with the rights holders and your study documents. Scoring and thresholds follow your protocol and statistical analysis plan.
Draft the epochs from your protocol with the AI study builder, review them, and test a re-randomization in the free sandbox.
Safety reporting
IBD drugs modulate the immune system, so screening is a safety control. Protocols typically require tuberculosis testing, hepatitis B and sometimes C status, a review of vaccination history and a stool test for C. difficile and other pathogens, because infection can mimic a flare. Record each result with its date and the laboratory as typed fields and add an edit check that blocks randomization if a required screening result is missing or out of date. The lab results eCRF template gives the repeating-row layout for the screening panel.
Adverse events follow the usual structure: onset, severity, seriousness, relationship, action and outcome. The adverse event form and the SAE report form are the starting points, and CTCAE grading is used by some sponsors for severity. Many IBD protocols also define adverse events of special interest, typically serious and opportunistic infections, and, depending on the mechanism, events such as thromboembolism, liver injury or malignancy. Build these as flags on the AE form so they can be listed without a manual search.
The IBD-specific trap is disease worsening. A flare of the underlying disease can be both an efficacy outcome and an event a sponsor would otherwise report. Protocols usually say whether worsening that is part of the expected course is recorded as an efficacy event or as an adverse event, and what makes it serious. Decide that in the data management plan before the first participant, and build the AE form and the efficacy forms to match, so the same event is not recorded twice or missed. The adverse event reporting software page describes the workflow.
Concomitant therapy
Classification of a participant often depends on medication. Corticosteroid-free remission needs a dated taper and a stop date. A rescue medication or a dose increase may count as a treatment failure under the protocol. Prior biologic exposure may define a stratum, as in participants who have failed a tumor necrosis factor antagonist. Record each drug as a repeating row on the concomitant medications form, with start date, stop date, dose and indication, each with its own audit trail, and add an edit check that asks for a reason when a prohibited drug appears.
Capture can calculate the minutes or hours between two date-times, which helps when a protocol sets time rules, and a visit window around each scheduled week makes an out-of-window visit visible at entry. For randomization at the end of induction, with stratification by prior biologic failure, concomitant steroid use or disease location, see randomization without a CRO. Blinded roles never receive treatment-arm values, so a blinded endoscopy reader and an unblinded statistician can work in the same study.
Build sequence
Upload the protocol and let the AI study builder propose induction, maintenance and extension visits for your review.
A daily diary task with reminders and windows; separate fields for local and central endoscopy reads and for each score component.
Infection screening results with date rules, and baseline disease activity cut-offs as edit checks.
Enter practice participants through the end of induction, check the data used for response, and walk through re-randomization.
Approved forms lock for live use. Pay only when real participants enroll.
Before first participant
Which days count, how baseline normal stool frequency is set, how bowel preparation days are handled.
Which endoscopy read feeds the endpoint, and how disagreements are handled.
Efficacy event or adverse event, and when it becomes serious.
TB, hepatitis, stool pathogens and vaccination data, with validity periods.
Rights-holder terms recorded in the study documents.
That page covers GI trials broadly, including IBS, and focuses on diaries. This page is specific to Crohn’s disease and ulcerative colitis: induction and maintenance periods, re-randomization, endoscopy score components, infection screening and disease worsening.
Yes. Each component is a typed field on a visit form with its own date, so the derived score can be reproduced. Local and central endoscopy reads can be separate variables. Scoring definitions follow your protocol.
Randomization is part of the platform, with stratification factors you define. Response at the end of induction is determined from the data you collect, and blinded roles never receive arm values.
No. The diary opens from a secure link in the phone browser, with reminders and completion windows.
Follow the protocol. Many define worsening of the underlying disease as an efficacy outcome unless it meets a defined threshold. Decide this in the data management plan and build the forms to match.
No. Capture does not supply or verify licensed instruments or their wording. Licence controls exist only on participant questionnaires; clinician-rated forms keep their licence in the study documents.
Keep exploring
EDC for gastroenterology and IBD trials
Diary windows and GI endpoints.
Patient diary software
Daily diaries with reminders.
Lab results eCRF template
CRP, calprotectin and screening labs.
Adverse event eCRF template
AE and AESI structure.
Randomization without a CRO
Stratified allocation at end of induction.
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