Investigational Product Accountability and Handling
Investigational product (IP) is the sponsor's property held in trust by the site, and the paper trail must reconcile to the unit. Under 21 CFR 312.61 the investigator may administer IP only to subjects under their supervision, and may not supply it to anyone not authorised. 312.62(a) requires records of receipt, disposition, and return or destruction.
The accountability chain
Receipt (date, quantity, lot, condition) → storage (conditions per label or IB, temperature logs, restricted access, quarantine area for expired or out-of-range stock) → dispensing (correct kit per randomisation, correct subject, documented) → returns and reconciliation → destruction or return with written authorisation.
Conditions that trigger action
- Temperature excursion: quarantine the product, notify the sponsor immediately, retain the data, and await a stability assessment before further dispensing.
- Wrong kit dispensed: a protocol deviation that must be reported and assessed for impact on blinding and subject safety.
- Expired product on shelf: segregate and label; never dispense.
- Blinding: only the unblinded pharmacist or designee accesses assignments; emergency unblinding is documented and communicated to the sponsor without revealing treatment to the blinded team.
Traps
- Destroying IP at the site without written sponsor authorisation.
- Accepting a log signed only by the pharmacist when the delegation log does not permit that person to dispense.
- Reconciling "approximately": accountability must balance exactly, with an explanation for every missing unit.
- Overlooking associated supplies (diluents, placebo, devices) that follow the same rules.
Rule of thumb: units received − units dispensed − units returned − units destroyed = units on hand. Any remainder is an unresolved finding, not a rounding error, and belongs in the monitoring report with an action and due date.