TENVIA · EXAMPLE PROTOCOL INTELLIGENCE RECORD
Two more collections. One connected review.
Fictional RD-204 study · 120 participants · Prepared website example
This illustrates a discussion and working-draft decision. It is not a product export, customer record, protocol approval or clinical recommendation.
| Starting point | Draft v0.2 lists one exploratory blood sample at Week 4 without a stated purpose. |
|---|---|
| Proposal | Add collections at Weeks 8 and 12, within scheduled visits, to explore biomarker patterns. The scientific justification and frequency require specialist review. |
| Declared time | 10 minutes per collection. Starting schedule: 10 minutes per participant, or 20 hours across 120 participants. Proposed schedule: 30 minutes per participant, or 60 hours. Assumes full attendance; excludes other procedures, travel, waiting, processing and costs. |
| Source examined | ICH E8(R1), General Considerations for Clinical Studies, §2.1, printed page 2. This provides general context on scientific necessity and participant burden; it does not establish the appropriate biomarker, population or sampling frequency. Study-specific clinical evidence is not supplied. |
| Clinical Operations comment | Are the proposed collections within scheduled visits? Distinguish collection time from total visit time. |
| Medical Writing response | Draft v0.3 clarifies the proposed visit wording and retains the scientific review question. |
| Proposed v0.3 wording | Exploratory blood samples at Weeks 4, 8 and 12, within scheduled visits, to explore biomarker patterns. Scientific justification and sampling frequency require specialist review. |
| Working-draft decision | Keep the extra collections on hold until they are scientifically justified. Keep Week 4 as the starting schedule. The proposed wording remains available for review, not accepted into an approved protocol. |
| Alternatives considered | Retain Week 4 only; add Week 8; or add Weeks 8 and 12. The example keeps the additional collections on hold because study-specific scientific justification has not been supplied. Retaining the starting schedule is not a new clinical endorsement. |
| Recorded by | Sponsor study lead (fictional role) · Example day 2 · v0.3 review record. |
| Open question | Clinical Development: what study-specific evidence supports the additional collections? |
| History retained in this illustration | Starting wording, proposal, source and limitations, comment, response, draft decision and unresolved question. |
| Jurisdiction considerations | No US/FDA, EU/EEA or UK applicability assessment has been completed in this fictional record. The responsible regulatory team must examine applicable sources and record its conclusions before any real release. |
| Source and version trail | Original content: v0.2 visit schedule. Review context: ICH E8(R1), section 2.1. Proposed wording and draft decision: v0.3. Reviewer roles and the open scientific question are retained above; there is no verified customer audit trail. |
| Release and document package | Not released. No Sponsor signature or formal authorisation is recorded. Word/PDF product exports and a complete customer Protocol Intelligence Record must be confirmed for the evaluated product version. |
Inspect the original ICH E8(R1) guideline (PDF)
Confirm supported record fields, output formats and approval requirements for your evaluation. The separate guided demo lets you explore a proposal; its browser session does not change this prepared record.