Study Medication and Medical Devices

Ask a coordinator where the study drug is, and they will point at a locked fridge. That is the wrong answer — or at best a quarter of it. The right answer is a ledger: at any moment, you can say where every unit that ever entered your site is now, and prove it.

The investigational medicinal product (IMP) — the drug or biologic your trial exists to test — is medicine and evidence at once. Handled carelessly, it stops being either: a participant receives a product nobody can vouch for, and the trial's central question — who got what, and what happened — loses its answer. Responsibility for the product at the site rests with the investigator, however much of the daily handling is delegated to a pharmacist or a study nurse; the delegated hands work under the investigator's oversight. ICH E6(R3)

This module walks the product's life at your site in order — the label it arrives with, the cold chain it lives in, the assignment that decides who receives it, and the ledger that accounts for it — then crosses to medical devices, where the discipline survives intact but the rulebook changes.

Learning Objectives

After this module, you can:

• Verify an IMP shipment at the door — label, quantities, condition, transit-temperature record — and refuse what you cannot verify
• Act on a temperature excursion: quarantine the product, document the data, and dispense nothing until the sponsor's written assessment clears it
• Apply the site mechanics of randomisation and blinding — and run an emergency code-break: right person, documented, sponsor informed
• Keep an accountability log that reconciles — every unit traceable from receipt through dispensing to return or destruction, every discrepancy explained in writing
• Run a device trial's site duties under ClinO-MD: track every device, and recognise, document, quarantine, and report a deficiency to the sponsor

What Arrives Is Evidence: GMP and the Label

Before a single vial reaches you, the sponsor has done the heavy lifting. Investigational products are manufactured under Good Manufacturing Practice (GMP) — the quality rules for pharmaceutical production: qualified equipment, controlled processes, batch-by-batch testing, documented release. Module 8 introduced this as a principle; your site is where it has to survive contact with reality, because a perfectly manufactured product stored or dispensed carelessly arrives at the participant as neither. ICH E6(R3)

The point of contact between the sponsor's world and yours is the label, and on an investigational label nothing is decorative. It carries a trial reference code that identifies the trial, site, investigator and sponsor; the batch or code number — how a recall or a stability problem finds its way to your shelf; the participant or treatment number; the dosage form and quantity; the storage conditions; the period of use, written month/year so nobody misreads a date; the phrase "For clinical trial use only"; and the contact for information and for emergency unblinding. That last item matters at two in the morning, and we will come back to it. EU GMP Annex 13

Receipt is a verification step, not a delivery signature. Before anything goes on a shelf:

• Quantities — counted against the shipping documentation, not assumed from it
• Condition — packaging intact, nothing leaking, crushed or thawed
• Papers — batch numbers and use-by dates matching the documentation that travelled with them
• Temperature — for cold-chain products, the transit logger's record, reviewed before acceptance

Then the delivery becomes the accountability log's first entry: dates, quantities, batch numbers. ICH E6(R3)

Storage and the Cold Chain

The storage rule is one sentence: the product is stored as the sponsor specifies, and you can prove it was. Access restricted to the people named for it in the delegation log; trial product physically separated from clinic stock, so a tired colleague cannot dispense the wrong thing; and for temperature-sensitive products, monitoring that is continuous and comes from a calibrated device — a gap in the record is a gap in the proof. ICH E6(R3)

Sooner or later, the record will show an excursion: a weekend power cut, a fridge door not quite shut, a compressor dying quietly on a Friday afternoon. Module 8 used exactly that scenario to show the GCP principles thinking; here is the same event as procedure.

The safeguard logic runs deeper than fridges: everything about product handling is arranged so that integrity, use per protocol and participant safety hold even when something slips. ICH E6(R3)

Who Gets What: Randomisation, the Blind, and Breaking the Code

In a randomised trial, an algorithm — not a clinician — decides which participant receives which treatment. The reasons live with trial design and statistics, and they are Module 15's to teach. Your end of it is operational and strict: follow the trial's randomisation procedure exactly as the protocol defines it — the system's assignment, in sequence, with no swapping, no holding a "better" kit for a sicker patient, no exceptions for enrolment convenience. ICH E6(R3)

Blinding is protected in the same operational register. Storage and dispensing are arranged so nobody learns an assignment who shouldn't: identical packaging stays identical, randomisation documents stay away from outcome assessors, and where the protocol uses an unblinded pharmacist, that person's records are kept where blinded staff won't meet them.

Then there is the two-in-the-morning call the label anticipated. If a participant's emergency treatment depends on knowing what they received, you unblind — and GCP expects you to be prepared and capable of doing it from the start of the trial, without undue delay or hindrance. You do not need the sponsor's permission first; you need the code-break procedure you rehearsed — the trial's assignment system, a sealed envelope, or the emergency contact the label carries for exactly this call — and afterwards you promptly document the unblinding and explain it to the sponsor, the same duty that covers any premature unblinding, accidental ones included. Whether a safety event also triggers unblinding inside the sponsor's reporting machinery is Module 13's territory. ICH E6(R3)

The Log That Has to Add Up: Dispensing, Returns, Destruction

Dispensing has one governing clause — the product is used only in accordance with the approved protocol — and a short pre-flight check. The right participant: consent signed and current before the first kit leaves your custody (Module 7's three-part test, verified here as a dispensing step), eligibility met. The right product: the assignment from the randomisation procedure, in date, from a batch with no quarantine flag. Then the log entry: date, quantity, batch number, participant code — and with it the record that the participant received the doses the protocol specified. ICH E6(R3)

Custody does not always end at your door. The product may be shipped to the participant's location or dispensed nearer to them, and administered by site staff, the participant, a caregiver or a local health professional — the trial's reach extends, and the record-keeping extends with it: shipment records, confirmation of receipt, the same cold-chain evidence in transit. ICH E6(R3)

Participants also explain the log's most human line: what came back. Unused product is returned, counted and recorded; the participant who used more, less or differently than expected is asked, and the answer is written down. The instruction for use — explained at dispensing, checked at intervals — is part of the same loop. ICH E6(R3)

At the end — of a participant's trial, or the whole trial's — the ledger closes. Returned and unused product goes back to the sponsor, or is destroyed or otherwise disposed of at the site only where the sponsor has authorised that disposition; the log records which, when, and in what quantities. ICH E6(R3)

This is where the opening question collects its real answer. Where is the study drug? Some of it is in the fridge; most of it is gone — dispensed, swallowed, returned, destroyed — and the ledger can say exactly where, unit by unit, batch by batch. That ledger is an essential document: it outlives the trial in the site's files, under Module 11's rules.

Devices: Same Discipline, Different Rulebook

Swap the vial for an investigational implant and the discipline you have just learned survives whole — but the law under it changes. Device trials leave the KlinV for a parallel ordinance, ClinO-MD, inside the legal architecture Module 6 mapped; authorisation still runs through the ethics committee and Swissmedic, in the division of labour Module 3 set out. What this section adds is the site-level consequence. ClinO-MD

ClinO-MD works by importing the European rulebook: sponsor and investigator must fulfil the requirements of EU-MDR Article 72 and Annex XV for the conduct of the investigation, and investigators must hold qualifications the ordinance spells out itself. ClinO-MD Compliance may be demonstrated through designated technical standards — the role in which the device-trial standard Module 8 introduced, ISO 14155, returns; the KlinV names that standard directly only for the device-like products that stay under its own roof. KlinV

Accountability translates almost word for word. Devices are tracked per unit and serial number rather than per batch: receipt, storage, deployment or implantation, explantation where it applies, return. One line changes, though, and it changes your reflexes: a returned tablet is inert, but a returned device is evidence of how it behaved — which is why device custody ends differently, as the deficiency procedure below shows.

The genuinely new duty is the device deficiency — and the point is that no one needs to be harmed. ClinO-MD requires documentation, in standardised form, of any deficiency "that might have led to a serious adverse event if appropriate action had not been taken, intervention had not occurred, or circumstances had been less fortunate." The near-miss is the reportable event. ClinO-MD

Your site-level procedure mirrors the excursion drill:

• Recognise — anything about the device that did not perform as intended: a fault, an unexpected battery depletion, a misleading instruction for use.
• Document — what happened, when, how it was discovered, with the device's serial number.
• Quarantine — take the device out of service and hold it; it is the physical evidence of its own failure.
• Report to the sponsor without delay — the formal documentation duty and the onward reporting to the ethics committee and Swissmedic run through the sponsor.

The definitions behind these events and that whole reporting machinery are Module 13's — your job is that nothing reportable dies quietly at the site. ClinO-MD

Module Summary

You can now verify an IMP shipment at the door — label, quantities, condition, transit-temperature record — and refuse what you cannot verify. You can act on a temperature excursion: quarantine, document, notify, and dispense nothing until the sponsor's written assessment clears it. You can apply the site mechanics of randomisation and blinding, and run an emergency code-break without delay, documented and explained to the sponsor afterwards. You can keep an accountability log that reconciles — received equals dispensed plus returned plus destroyed plus in stock, every discrepancy explained in writing. And you can run a device trial's site duties under ClinO-MD: every unit tracked, every deficiency recognised, documented, quarantined and reported to the sponsor — harm or no harm.

The fridge answers tonight's question: where is the drug. The ledger answers every question that comes after — who received what, when, and how you know. Keep the one locked, and the other true.