Procedures relating to medicinal products & medical devices
For the performance of research involving medicinal products, the ICH-GCP guidelines must also be complied with.
- Responsibilities sponsor H5 of the ICH-GCP guidelines
- Responsibility Local principal investigator H4 of the ICH-GCP guidelines.
According to the instruction 'prescribing medication'
Study medication must be prescribed in Epic through separate study medication ERXs. These ERXs are expanded per study and can be recognized by the ERX name, which starts with the name of the study, for example: "STUDY ACE-CL-311 fludarabine infusion". In these study medication ERXs, the patient's study number is requested by default.
If a study medication ERX has not (yet) been developed for a particular study, but the patient does receive study medication, then the dummy ERX "study medication (not prescribed in Epic)" (in Dutch: studiemedicatie (niet in Epic voorgeschreven)) should be used. This can also be found under the synonym HELP.
In the dummy ERX the study name, the drug and the dosage, route of administration and frequency can be indicated.
NOTE: Prescribing the dummy ERX serves to indicate that a patient is taking study medication, for completeness of the medication record. The order does not initiate an order, for this a paper prescription must be submitted separately to the Kenniscentrum (location AMC) or research medication (location Vumc).
In most clinical studies, accountability at the study level (i.e. the logistics of supply, distribution and stock management of the research product) takes place in cooperation with the pharmacy. If all has gone according to plan, you will have contacted the Kenniscentrum Geneesmiddelenonderzoek during the preparations for your study.
The researcher bears personal responsibility for proper administration of accountability for each patient: Which medication and dosages were given to the subjects during the study? Do they correspond to what is specified in the protocol? Do the numbers match what was received from the pharmacy?
To support the research team an Investigational Medicinal Product accountability log: subject level was developed.
The CMC has also developed an Investigational Product accountability log: subject level for other non medicinal products.
The purchase and use of medical devices within Amsterdam UMC is subject to certain conditions, in order to limit risks to patients, operations and finances. To this end, Amsterdam UMC uses a procurement file—a report form that guides the purchaser of medical devices through the procurement process according to a number of crucial questions. The report form ensures that applications proceed through a workflow that includes all relevant preparations for purchase.
Medical devices that are provided (sometimes free of charge and/or for the duration of the trial) by an external manufacturer and used for research procedures, such as ECG equipment or blood pressure monitors, also have to be registered. Please contact: firstname.lastname@example.org
In the case of research with a medical device, the researcher bears personal responsibility for proper administration of accountability for each patient: Which device was given, used, implanted etc. to which subject during the research? Does this correspond to what is specified in the protocol? Is the stock management accurate?
To support the research team, the CMC has developed an Investigational product accountability log: subject level.