Every unit of study drug that arrives at a site must be accounted for: received, stored, dispensed, returned or destroyed. This template gives you the columns, the reconciliation method and the link to the randomization record, so the numbers add up when the monitor asks.
Free sandbox · No credit card · 21 CFR Part 11 aligned
Received
120
Dispensed
74
On hand
41
Key points
Template
Keep one log per product, strength and site, or one per kit type. Your sponsor may supply its own form; use this to check that yours covers the same ground.
| Column | Content |
|---|---|
| Study, site and product | Protocol number, site number, product name, strength, formulation. |
| Entry number and date | Sequential entry per log, with the date and time of the transaction. |
| Transaction type | Received, dispensed, returned by subject, returned to sponsor, destroyed, transferred, lost or damaged. |
| Batch or lot, kit or unit number | Identifiers from the label; for blinded studies, the kit number only. |
| Expiry or retest date | From the label, checked against the expiry rule in the protocol. |
| Quantity in, quantity out | Units added or removed in this entry. |
| Running balance | Units on hand after this entry. |
| Subject code and visit | Coded subject ID and visit; no names. |
| Dose instruction or regimen | As prescribed, where relevant to the count. |
| Storage location and condition | Fridge, room-temperature cabinet; temperature log reference. |
| Performed by | Name or initials and signature of the person, who should appear on the delegation log. |
| Verified by | Second person check for receipt, destruction and large adjustments. |
| Comments and discrepancy reference | Reason for any difference, and a link to the deviation if one was raised. |
Adapt the columns to your protocol and your sponsor's forms. For blinded studies, the log held by blinded staff must not show treatment arm.
Two records, one picture
The randomization log records who was allocated, when, and under which number. Depending on the study it lives in the randomization system, with a sealed envelope record or on a site log that lists randomization numbers in order against coded subject IDs. The accountability log records the physical product. The two meet at dispensing: a subject with a randomization number receives specific kits, and the accountability log records which kits went to which coded subject at which visit.
Keeping them aligned is what lets a monitor trace a unit from the shipment to the subject and back. When allocation is by a system, the dispensing instruction comes from that record, and the site records what it actually handed over. When allocation uses sealed envelopes or a site list, the site must copy the numbers carefully and the second person check matters more. If the study is blinded, only an unblinded pharmacist or designated unblinded staff should hold the arm-level record, as described in blinded and unblinded role management.
For a deeper look at how allocation lists are produced, see clinical trial randomization software and the randomization list generator.
A site-level randomization log usually records the randomization number, date and time, coded subject ID, stratification values used, the person who randomised, and the dispensed kit numbers. For blinded studies, it should not record the arm. Keep it with, but separate from, the identification code list described in the screening and enrollment log template.
Receive
Check seals, temperature record, count against the packing slip
Store
Locked, access-limited, temperature monitored
Dispense
Per randomization record, to a coded subject at a visit
Return and count
Unused product counted back at the next visit
Reconcile and destroy
Balance checked, discrepancies explained, disposition approved
Worked example
Reconciliation is simple arithmetic done regularly. These numbers are invented for illustration.
| Line | Units | Note |
|---|---|---|
| Received from sponsor | 120 | Two shipments of 60 units |
| Dispensed to subjects | 74 | Across 21 subjects and several visits |
| Returned by subjects, unused | 12 | Counted and logged at return visits |
| Returned to sponsor or destroyed | 0 | None yet |
| Expected on hand | 58 | 120 minus 74 plus 12 minus 0 |
| Physical count | 56 | Counted by two people |
| Difference | 2 | Investigate and document the reason |
A difference is a prompt to look, not proof of wrongdoing. Check for unlogged returns, a wrong entry or a damaged unit before raising a deviation.
Build the study, visits and dispensing visits in the free sandbox, so the log and the schedule line up from day one.
How to use it
Open one log per product and site when the first shipment arrives. Record the count, batch, expiry and condition on receipt, and sign.
Each dispensing, return, transfer and destruction is an entry with the date, quantity, subject code and initials.
Count returned units at the visit. If the number differs from what was expected, record the difference and the reason the participant gives.
Many sites reconcile monthly and before each monitoring visit. Use a second person for the physical count.
Return or destroy unused product only as the sponsor instructs, file the certificate or receipt, and finalise the log.
In Capture
Capture is an all-in-one clinical trial platform where randomization sits in the same system as the visit schedule, forms and audit trail. That means the dispensing visits in your protocol, the coded subject IDs and the randomization record all come from one place. For kit tracking and a drug accountability report, see the IMP inventory page, which describes the workflow in detail.
Kit K-10418 · custody history
Only physically possible combinations can be saved.
Before the first shipment
Investigator or designated pharmacist, listed on the delegation log.
Locked space with limited access and temperature monitoring.
Sponsor form or this template, one per product and site.
No names in the log.
Who may see allocation, and which log blinded staff hold.
Who counts returns, and how differences are recorded.
Monthly and before monitoring visits.
Sponsor approval, certificate, witness where required.
Inspection readiness
Monitors check that receipt records match shipment documents, that dispensing matches the protocol and randomization record, that storage conditions were maintained and that reconciliation was done. Common findings include missing signatures, entries made days after the event, subjects receiving the wrong kit, expired product still on the shelf, unlogged returns and counts that do not reconcile. Most are avoided by logging in real time and reconciling regularly.
Treat the log as a source document. Corrections should be a single line through the entry, with the date, initials and reason, so the original stays legible. For deviations that arise, see protocol deviation tracking software and the delegation log template, which supports the check that the person who signed was authorised. The monitoring visit report template shows how these checks are written up.
A drug accountability log is the record of every unit of investigational product at a trial site: received, stored, dispensed to subjects, returned, destroyed or lost. It keeps a running balance so that what should be on hand can be compared with a physical count.
ICH GCP places responsibility on the investigator or institution, who may assign the task to a designated pharmacist or other appropriate person. Whoever keeps the log should be listed on the delegation log and trained on the protocol.
Date, transaction type, batch or kit number, expiry, quantity, running balance, coded subject ID and visit, who performed and verified the entry, and a comment field for discrepancies. Do not record participant names.
The randomization log records the allocation of subjects, and the accountability log records the physical product. They connect at dispensing, where a randomised subject receives specific kits that must be logged against that coded subject.
Protocols and sponsors vary. Many sites reconcile monthly and before each monitoring visit, with a second person for the physical count. Follow your protocol and pharmacy manual.
Capture provides randomization and a study record, and the IMP inventory page describes its kit tracking. Whether it replaces the pharmacy log of record depends on your sponsor procedures and local rules, so agree that before the study starts.
No template is. Use it to check coverage, then follow your protocol, the sponsor's pharmacy manual and local regulations. Check the current text of the rules that apply to you.
Keep exploring
IMP inventory and drug accountability software
Kit tracking workflow.
Clinical trial randomization software
Allocation in the EDC.
RTSM software
Randomization and supply.
Blinded and unblinded role management
Who may see allocation.
Delegation log template
Who is authorised to sign.
Screening and enrollment log template
The sibling site log.
Protocol deviation tracking software
Recording discrepancies.
Monitoring visit report template
How checks are written up.
Free sandbox with every feature. No credit card, and you pay only when you go live with real participants.