Procedures relating to medicinal products & medical devices

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Medicinal products

When conducting clinical trials involving medicinal products, compliance with the ICH-GCP guidelines is mandatory.

Responsibilities

Prescribing study medication

Study medication must be prescribed in Epic through separate ERXs, according to the instruction Prescribing Medication. The study medication ERXs are expanded for each study and can be identified by their ERX name, beginning with the study title. For example: "STUDY ACE-CL-311 fludarabine infusion". In the study medication ERXs, the patient's study number is requested by default.

If a study medication ERX has not (yet) been developed for a study, but study medication is still administered, use the dummy ERX: "study medication (not prescribed in Epic)" (in Dutch: studiemedicatie (niet in Epic voorgeschreven)). This can also be found under the synonym HELP.
Indicate the following in the dummy ERX: study title, drug name and dosage, route of administration and frequency.

Note: the dummy ERX serves only to document that the patient is taking study medication for completeness of the medication record. It does not generate an actual order. For this, a paper prescription must be submitted to the Kenniscentrum Geneesmiddelenonderzoek.

Accountability at study and patient level

In most clinical trials, accountability at the study level (including logistics of supply, distribution and stock management of the study medication) is handled in cooperation with the pharmacy. Ideally, contact with the Kenniscentrum Geneesmiddelenonderzoek was established during the study preparation phase.

The researcher is personally responsible for accurate documentation and accountability of study medication for each participant:

  • What medication and dosage were administered to study participants?
  • Does it match the study protocol?
  • Do the records correspond to the medication received from the pharmacy?

To support research teams, the following tools are available:

Medical devices

The purchase and use of medical devices within Amsterdam UMC must comply with certain conditions to limit risks to patients, operations, and finances. To ensure this, Amsterdam UMC uses a procurement file—a report form guiding the purchaser of a medical device through the procurement process via several crucial questions. The report form ensures that all applications follow a workflow coering the necessary preparations for purchase.

Medical devices provided by external manufacturers - whether free of charge and/or for the duration of a study - must also be registered before use in study procedures. This includes ECG equipment or blood pressure monitors. For more information, contact: adviesmedischehulpmiddelen@amsterdamumc.nl

Accountability

In clinical investigations involving medical devices, the researcher is personally responsible for accurate documentation and accountability of medical devices for each participant:

  • Which device was provided, used, or implanted?
  • To which participant was the device assigned?
  • Does it match the study protocol?
  • Is the stock management accurate?

To support research teams, the following tool is available: Investigational product accountability log: subject level.