Glioblastoma trials judge response on MRI under RANO, adjust for steroid dose and performance status, and watch seizures and cognition. Capture keeps these in one study with a field-level audit trail. Build it in the free sandbox, no credit card, and pay only when you go live.
Free sandbox · No credit card · 21 CFR Part 11 aligned
| Assessment | Post-op | Pre-RT | Post-RT MRI | Cycle 1 | Cycle 3 | Cycle 6 | Follow-up |
|---|---|---|---|---|---|---|---|
| Contrast MRI, RANO response | |||||||
| Performance status (KPS or ECOG) | |||||||
| Neurologic exam and steroid dose | |||||||
| Cognitive and QoL questionnaires | |||||||
| Seizure diary (participant or caregiver) | D | D | D | D | D | D |
x = done at this visit, D = diary between visits
What a glioblastoma trial needs from its EDC
The study data
Glioblastoma response is judged on contrast-enhanced MRI using the Response Assessment in Neuro-Oncology (RANO) criteria. The 2023 RANO 2.0 update (Wen and colleagues, Journal of Clinical Oncology) recommends one set of criteria for high- and low-grade gliomas and, for newly diagnosed disease, replaces the post-surgical MRI with the post-radiotherapy MRI as the baseline. It also asks for confirmation of progression with a repeat MRI when the treatment carries a high chance of pseudoprogression, and for IDH wild-type glioblastoma it no longer evaluates non-enhancing disease except for antiangiogenic agents. Protocols still choose their own version, so confirm which one yours cites; the build follows from it.
For an EDC the practical consequence is simple. Each MRI is a dated record, one of them is labelled baseline, and the response at each later scan is recorded relative to it. If the protocol requires confirmation, record the date of the first suspected progression and the date and result of the confirming scan as separate fields, because the progression date used for PFS may be the first scan, not the second. Capture them with the scan date, the reader (site or central) and the product of perpendicular diameters or the volume if your protocol measures it. Where scans go to an imaging core laboratory, give that read its own form so site and central assessments never overwrite each other.
Overall survival is the endpoint most glioblastoma programs can rely on, and it is the simplest to define, which is why its data quality is sometimes neglected. Keep a short survival follow-up form with vital status, date last known alive, source of that information (clinic visit, caregiver call, registry check) and subsequent therapy. Schedule it with a visit window so lapses are visible, and let an edit check query a death date that precedes the last visit date.
Newly diagnosed trials usually build on radiotherapy with concomitant temozolomide followed by adjuvant temozolomide cycles, and many stratify by MGMT promoter methylation status, extent of resection and performance status. Record each as a typed field with its date and laboratory, and use them as stratification factors in randomization; see randomization without a CRO. Recurrent-disease trials have a different shape, with prior therapy lines and a time since last treatment rule, which belongs on the eligibility form.
Scan date
RSDTCBaseline scan used
RSBASEEnhancing lesion, product of perpendicular diameters
RSPRODDexamethasone dose at scan
CMDOSELower than previous scan
Response, site
RSORRESConfirmation scan required
RSCONFProtocol to build
| Protocol element | What the data looks like | Where it lives in Capture |
|---|---|---|
| Eligibility and molecular status | Histology, IDH, MGMT, resection extent, prior therapy | Screening form with edit checks |
| Tumor response | Scan date, baseline flag, measurement, response, confirmation | Visit eCRF form, with site and central reads as separate forms |
| Corticosteroids | Drug, dose, start, change, stop | Repeating rows on the concomitant medications template |
| Performance status | KPS or ECOG score per visit | Karnofsky or ECOG form |
| Cognition and function | Screening cognitive score, caregiver-reported function | MMSE or MoCA form structure; caregiver ePRO task |
| Seizures | Event count, type and antiseizure drug changes | Seizure diary on a phone |
| Safety | CTCAE-graded AEs, serious events | Adverse event form, SAE report form |
| Quality of life | Brain-tumor-specific and general questionnaires | ePRO task; EORTC QLQ-C30 structure (the brain module is built from your own licensed copy) |
Instruments are named for structure only. Licensed wording stays with your study documents; Capture does not supply or verify instrument licences, and licence controls exist only on participant questionnaires.
Upload the protocol, let the AI draft the schedule and forms for review, and test scan, steroid and survival logic with sample data. Free sandbox, no credit card.
Safety reporting
Safety in glioblastoma has three layers. The first is treatment toxicity, graded on CTCAE: myelosuppression with temozolomide, fatigue, nausea, and with antiangiogenic or investigational agents events such as hemorrhage, hypertension or thromboembolism. The CTCAE grade lookup shows published grade criteria for common terms in v5.0 and v6.0; the investigator assigns the grade. The second layer is the disease itself: seizures, headache, focal deficits and cognitive decline can be tumor progression, treatment effect or adverse event, and the protocol must say how each is recorded. The third is supportive medication, since corticosteroids bring hyperglycemia, infection risk, mood change and myopathy, and antiseizure drugs have their own interactions.
Neurologic deterioration is the data question that deserves a rule. Decide in the data management plan whether a new deficit is an adverse event, a progression marker or both, and build the forms so the same change is not entered in two places with different dates. For serious events, the SAE report form and SAE deadline calculator support timely reporting, and the broader flow is on the adverse event reporting software page.
Many participants cannot reliably self-report as the disease advances. Plan for a caregiver or proxy to complete diaries and questionnaires, record who completed each entry, and keep the proxy rules in the protocol. Between-visit seizure counts are a good example: a phone diary shared with a caregiver captures events that never reach clinic notes. Use reminders and completion windows to keep entries current, and treat the diary as supporting data for the investigator.
Try it
Check the published criteria for terms you grade often, then enter the grade on the AE form.
| Grade 1 | <LLN - 1500/mm3; <LLN - 1.5 x 10e9 /L |
|---|---|
| Grade 2 | <1500 - 1000/mm3; <1.5 - 1.0 x 10e9 /L |
| Grade 3 | <1000 - 500/mm3; <1.0 - 0.5 x 10e9 /L |
| Grade 4 | <500/mm3; <0.5 x 10e9 /L |
| Grade 5 | – (grade not available) |
Source: NCI CTCAE v5.0, published 27 November 2017 (ctcae-v5.0.xlsx, dctd.cancer.gov).
*Instrumental ADL: preparing meals, shopping for groceries or clothes, using the telephone, managing money, etc. **Self care ADL: bathing, dressing and undressing, feeding self, using the toilet, taking medications, and not bedridden. A semicolon means “or” within a grade; a dash means the grade is not available for that term. LLN and ULN are the lower and upper limits of normal.
Reference only: 34 common terms, not the full CTCAE, and not validated software. Use the version your protocol names. Grading, seriousness and causality are the investigator's clinical judgement; always check the official NCI document.
Build sequence
Upload the protocol and let the AI study builder propose chemoradiation, adjuvant cycles and follow-up visits. A person reviews before anything is saved.
A dated scan form with a baseline flag and confirmation fields, repeating steroid rows, and performance status at every visit.
Date logic across scans, progression and death; steroid dose ranges; required confirmation scan when the first scan reads progression.
Seizure diary and questionnaires with reminders and windows, with a field for who completed each entry.
Walk practice participants from surgery to death, review the audit trail and exports, then approve forms and start live data collection.
Sites and export
Glioblastoma trials often run at a limited number of specialist centers, with a central imaging review and sometimes a central pathology review. Capture supports site-level participant numbering, a site coordinator portal and by-site filtering; see multi-site clinical trial management. Blinded roles never receive arm values, which helps when the imaging reader must remain blinded to treatment.
For analysis, CSV and Excel exports carry an automatic data dictionary, and CDISC SDTM export produces SAS XPT datasets with Define-XML (details). Planning a survival endpoint? Start with the survival sample size calculator. For general oncology build patterns such as BSA dosing and dose escalation, see EDC for oncology clinical trials.
Before first participant
Which criteria, which baseline scan, and when confirmation is required.
Site or central read for the endpoint, and handling of disagreement.
How dose is captured at each scan and how it enters response.
Who may complete diaries for the participant, and how it is recorded.
Adverse event, progression marker or both.
Rights-holder terms for each questionnaire stored in the study documents.
Yes. Each MRI is a dated record on a visit form with the baseline scan flagged, the measurement, the response and any confirmation scan. The response itself is determined by the investigator or central reader; Capture stores and audits it.
As repeating rows on a concomitant medications form, with start, change and stop dates, each row with its own audit trail. You can also ask for the dose on the day of each scan.
Yes, by a secure link on a phone. Add a field for who completed the entry and put the proxy rules in the protocol. Capture does not verify who is holding the phone.
Yes. Blinded roles never receive treatment-arm values, enforced by masked database views, and central reads can sit in a separate form.
On the adverse event form, with separate fields for seriousness, relationship and action. The CTCAE grade lookup tool shows published criteria for common terms; the investigator assigns the grade.
Yes. Capture is used from Phase 1 through Phase 3, with site-level numbering, a site coordinator portal and by-site exports.
Capture provides Part 11-aligned controls: a field-level audit trail, electronic signatures and role-based access. Compliance is shared with the sponsor’s own validated use of the system. This is not legal advice.
Keep exploring
EDC for oncology clinical trials
General oncology build patterns.
CTCAE grade lookup
Published grade criteria for common terms.
Seizure diary template
Participant or caregiver event diary.
Karnofsky performance status template
Performance status form structure.
Survival sample size calculator
Size an OS endpoint.
Free sandbox with every feature. No credit card, and you pay only when you go live with real participants.