Investigational Product and Device Management
This domain tests custody of the investigational product and the study device: receipt, storage, dispensing, return, destruction, blinding, and the paperwork that proves all of it. Items often hinge on a temperature excursion, a kit-number mismatch, or an unblinding that was not medically necessary.
Accountability for drugs
- Receipt, inventory, storage conditions, dispensing to the correct randomised participant/kit, returns, and final reconciliation - ICH E6 §4.6 and 21 CFR 312.62(a).
- Destruction only where local law and the sponsor authorise it, and only with a record; otherwise return to the sponsor.
- Dispense only within expiry and only to participants whose eligibility and randomisation are confirmed.
Excursions and expiry
Quarantine affected stock, notify the sponsor, and do not dispense pending a stability assessment. Document the excursion (date, duration, temperature range, affected kits) in the accountability record and file the sponsor's disposition decision.
Blinding and unblinding
Emergency unblinding is justified only when knowledge of treatment is needed to manage the participant's care. Record who unblinded, why, when, and notify the sponsor; the participant is usually withdrawn from blinded treatment. Code-break envelopes or interactive systems must be checked at monitoring.
Devices (21 CFR 812)
- Significant-risk devices require an IDE; the investigator obtains approval, keeps device accountability, calibration and maintenance records, and ensures use only by authorised staff.
- Unanticipated adverse device effects are reported to the sponsor and IRB within 10 working days; device deficiencies that could lead to a serious adverse event must also be reported.
Worked example
A study refrigerator logs 12 °C for six hours against a 2–8 °C requirement. Reasoning: immediately quarantine the kits and label them do-not-dispense; notify the sponsor with the excursion data; the sponsor evaluates stability data and instructs use or discard. Document the event and the disposition in the accountability log. Dispensing during the open question is a deviation and a potential safety issue.
Traps that cost marks
- Destroying expired or returned product without authorisation or a record.
- Assigning the wrong kit number, or dispensing to a participant who has not been randomised.
- Unblinding "just to check" without medical necessity.
- No calibration or maintenance documentation for a study device.
- Mixing site-purchased stock with sponsor-supplied investigational product.