EDC for tuberculosis clinical trials
A tuberculosis trial is judged on cultures, not symptoms: a series of sputum results, a composite "unfavourable outcome" and a long follow-up after treatment ends to catch relapse. Build the specimen series, adherence records and safety monitoring in Capture, and test it free.
- Sputum culture series
- Composite outcome and relapse follow-up
- Adherence, QTc and liver monitoring
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weeks
Supervised dosing
Primary outcome window
What a tuberculosis trial needs from its EDC
- A specimen series per participant: sputum collected on a schedule, each with smear, molecular test, culture result and drug-susceptibility data, sometimes weeks after collection.
- A composite primary outcome: recent late-phase TB trials generally combine bacteriological failure, relapse, death and treatment change into one "unfavourable" outcome, often with a separate "not assessable" category.
- Follow-up long after treatment stops: protocols have assessed outcomes at points such as week 60 or week 108, because relapse is the problem the regimen must prevent.
- Adherence is data: supervised dosing, missed doses and treatment interruptions determine how the outcome is classified.
- Drug-specific safety: electrocardiogram QTc, liver enzymes, neuropathy and blood counts, depending on the regimen.
The endpoint model
Why the outcome is a composite, and what that does to your data
Look at the protocols of recent registered TB trials. An ultra-short-course regimen study (NCT05556746) defines unfavourable outcome around absence of cure and measures favourable status by negative liquid culture at week 60. The CLO-FAST protocol (NCT04311502) treats some losses to follow-up as unfavourable and others as unevaluable, depending on whether the last culture was negative. The TB-PRACTECAL protocol counts death, treatment failure, discontinuation, loss to follow-up, still being on treatment at 108 weeks and recurrence as unfavourable. A systematic review of late-phase TB trials describes the same pattern, a composite unfavourable outcome that also carries a "not assessable" category for missing data. Early-phase studies may instead use time to sputum culture conversion or culture status at week 8. These are published examples; your regimen, setting and regulator will define your outcome, and the WHO treatment outcome definitions used in programmes are not identical to trial composites.
That structure turns into a classification problem for the database. Each participant ends up in a category through rules that combine many records: the last culture result, whether treatment was completed, whether a change of regimen occurred, whether a relapse was confirmed, and how long they were off follow-up. Do not try to code the category by hand. Capture the underlying facts as dated records (cultures, regimen changes, deaths, last contact) and let the outcome classification be derived in the analysis from exports, or reviewed by an adjudication committee. Capture's exports include a data dictionary, and an SDTM export (SAS XPT with Define-XML) is available for downstream programming.
Bacteriology adds its own twist: results arrive late. A liquid culture can take weeks to flag as positive or negative, a contaminated culture may need repeating, and a mixed result may require a repeat sample. Build the specimen form so collection date, result date and result status are separate fields, and use an edit check to raise a query when a culture older than a protocol-defined number of days has no result. That turns a forgotten laboratory result into a visible query rather than a missing data point at database lock.
Specimen
Collected on
COLLDTMolecular test
MOLECLiquid culture result
CULTPending 34 days after collection: check with the laboratory
Result received on
RESDTLeft blank while pending
Days since collection
DAYSPENDCalculated from dates, read-only
34 CalculatedProtocol to build
Tuberculosis protocol elements and where they live in Capture
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Eligibility and classification | Drug-susceptible or drug-resistant, site of disease, HIV status, prior treatment | Screening form with skip logic; eligibility form |
| Bacteriology | Smear, molecular result, culture, susceptibility results, dates | Repeating-row specimen form; lab ranges and results |
| Treatment and adherence | Regimen, supervised doses, missed doses, interruptions | Adherence and pill count capture; dosing record per visit |
| Concomitant therapy | Antiretrovirals, antiepileptics, hormonal contraception interactions, over-the-counter medicines | Concomitant medications form |
| Cardiac safety | ECG at set visits, QTc, QT-prolonging co-medication | QTc calculator; QTc Bazett and Fridericia as calculated fields |
| Liver and haematology | ALT, AST, bilirubin, haemoglobin, neutrophils | Lab results form with reference ranges and edit checks |
| Neuropathy, vision, symptoms | Graded adverse events, onset, action | Adverse event form; CTCAE grade lookup |
| Follow-up and outcome | Last contact, relapse work-up, death, loss to follow-up, adjudication | Follow-up form and contact attempt log; export for the outcome programme |
Capture does not connect to laboratory information systems, sputum culture instruments or national TB registers. Results are entered by site staff.
Build the specimen series and test the pending-result checks
Create the sputum form and the follow-up log, enter sample participants with late results, and watch the queries fire. Free sandbox, no credit card.
Operations
Supervised dosing, loss to follow-up and connectivity
Supervised treatment is a defining feature of many TB trials, whether by clinic visit, community health worker or video. The data question is who observed which dose. Build a dosing record with date, observer, and whether the dose was taken, and use the pill count or missed-dose form for self-administered phases. Treatment interruptions need a start date, a stop date and a reason, because the outcome rules often depend on how long treatment was paused. See medication adherence and pill count capture. Reminders to participants for questionnaires and visits can be sent through the platform.
Loss to follow-up is the second great risk, because the outcome depends on the last culture. Keep a contact attempt log with date, method and outcome, so you can show that reasonable efforts were made before declaring a participant lost, and so the rules in your protocol about the last culture result can be applied. Keep next-of-kin and alternative contact details current, subject to your ethics approval. Capture soft-deletes clinical data only and keeps a full audit trail, so a contact history cannot disappear.
Many TB trials run in sites with limited connectivity. Capture is browser-based and does not claim offline entry, so plan source documents and a transcription routine for sites that lose their connection, and test the real network in the sandbox before site initiation. For the African and Asian settings where many programmes run, see clinical trial software in Africa, South Africa and India; these pages describe hosting and regulatory context, and Capture hosts in the EU (Frankfurt) and the USA (N. Virginia). HIV co-infection is common in TB cohorts, and co-medication matters: see EDC for HIV clinical trials. Population-level prevention studies with household clustering have a related shape in EDC for vaccine field trials.
Before first participant
Tuberculosis study readiness checklist
Outcome definition written
Favourable, unfavourable and not-assessable rules, including loss to follow-up, agreed before database build.
Specimen schedule and laboratory manual
Collection windows, methods and result time limits written down.
Adherence method defined
Who observes doses and how missed doses are recorded.
Safety monitoring set
ECG, liver and haematology schedule with edit checks and stopping rules owned by the investigator.
Follow-up plan realistic
Contact attempt log, alternate contacts and visit windows to the final assessment.
Connectivity plan tested
Source worksheets and transcription routine for sites without reliable access.
Can Capture derive the unfavourable outcome?
It stores the underlying dated facts (cultures, regimen changes, deaths, last contact) and exports them with a data dictionary. The composite classification should follow your statistical analysis plan or an adjudication process.
How do we handle cultures that take weeks to result?
Keep collection date, result date and result status as separate fields and add an edit check that raises a query when a result is overdue by your protocol limit.
Does it support supervised dosing records?
Yes, as a dosing form with date, observer and a taken or missed answer, plus pill count and interruption records.
Does it work without internet?
Offline entry is not claimed. Capture runs in a browser, so plan paper source and transcription for sites with unreliable connectivity.
Can it monitor QTc for bedaquiline-containing regimens?
QTc Bazett and Fridericia are available as read-only calculated fields from ECG values, and an edit check can query a value above a protocol threshold. Which drugs need monitoring is set by the protocol and product information.
Can it connect to the laboratory system?
No integration is claimed. Results are entered from laboratory reports by site staff.
What does it cost?
The sandbox is free with every feature, no credit card. Plans for live studies are on the pricing page.
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Related pages
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