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Clinical Trial Drug-Accountability Log (Phase II)

Track IP dispensed, returned and reconciled for a Phase II efficacy trial — scheduled dates, protocol windows and status, all offline in your browser. For trial pharmacists.

Plan and track IP dispensed, returned and reconciled for a Phase II efficacy trial. Each row holds the subject ID, the visit/timepoint, the scheduled date, the protocol window (± days) and a status — so trial pharmacists can see at a glance what is due, what is in-window and what was missed. Runs entirely in your browser; no PHI leaves the device.

Use the protocol window (± days) to judge whether a visit is compliant. This is an operational planner — keep your validated EDC/eCRF as the system of record and export to CSV to reconcile.

No records yet. Add the first IP unit above — entries sort newest-first and the summary tracks completion and missed-window rates.
References: FDA Phase 2 IND guidance; Note: not a medical device; not a substitute for a validated EDC.

For research / operational use only. Not a medical device and not a substitute for validated clinical systems or professional medical judgement. Verify against your trial protocol, IRB/ethics approval and applicable regulations (GCP, 21 CFR Part 11, HIPAA/GDPR).

Free clinical-trial drug-accountability log for a Phase II efficacy trial: track IP dispensed, returned and reconciled with protocol windows and status — offline, PHI-private.

About Clinical Trial Drug-Accountability Log (Phase II)

A free, offline clinical-trial operations tool for trial pharmacists. Plan and track IP dispensed, returned and reconciled for a Phase II efficacy trial. Each row holds the subject ID, the visit/timepoint, the scheduled date, the protocol window (± days) and a status — so trial pharmacists can see at a glance what is due, what is in-window and what was missed. Runs entirely in your browser; no PHI leaves the device.

How to use Clinical Trial Drug-Accountability Log (Phase II)

  1. 1Add each subject's IP unit with its scheduled date and the protocol window.
  2. 2Update the status (Scheduled, Window open, Completed, Missed, Out of window) as visits happen, recording deviations in the notes.
  3. 3Export to CSV to reconcile against your EDC, brief your monitor, or report completion and missed-window rates.

Why use Clinical Trial Drug-Accountability Log (Phase II)?

  • Gives trial pharmacists a single, sortable view of IP dispensed, returned and reconciled so nothing slips through the cracks between EDC updates.
  • Tracks scheduled dates against protocol windows (± days) and flags missed or out-of-window events — the metrics monitors review for a Phase II efficacy trial.
  • Privacy-first: subject IDs and notes stay in your browser only. No PHI is uploaded, which keeps the tool usable under your site's data-handling rules.

Frequently asked questions

What does this clinical-trial drug-accountability log do?+

It gives trial pharmacists a lightweight, offline way to plan and track IP dispensed, returned and reconciled. Each entry records the subject ID, the visit or timepoint, the scheduled date, the allowed protocol window and a status, so the team can see what is due and catch missed or out-of-window events early — without waiting for an EDC report.

Is this a validated EDC or a medical device?+

No. It is an operational planning aid, not a 21 CFR Part 11-validated electronic data capture system and not a medical device. Keep your validated EDC/eCRF as the system of record; use this tool to organise day-to-day site operations and export to CSV to reconcile against the official data.

How are protocol windows handled?+

Each record stores the target date and a ± window in days. When a visit happens outside that window you mark it "Out of window", which the summary counts separately — exactly the compliance signal a monitor or sponsor looks at for a Phase II efficacy trial.

Is subject data kept private?+

Yes. All data lives in your browser via localStorage; nothing is sent to a server. To stay privacy-safe, use coded subject IDs (not names) — the tool is designed so identifiable PHI never has to be entered or transmitted.

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