“Home Care” may be included, if the following conditions are met:
- The utilisation of “Home Care” is justified by the patient's diagnosis or condition.
- The investigator/principal investigator who is responsible for the conduct of the clinical trial at the particular trial site must agree to it.
- Trial subjects must not be exposed to a higher risk than that posed by the completion of the same procedures at the trial site (a documented risk analysis is expected).
- The utilisation of “Home Care” must be clearly described in the clinical trial protocol and in the informed consent that were approved by SÚKL and by the ethics committee.
- The patient must also agree to the utilisation of “Home Care” as it is a rather significant interference in the patient's private life.
- Medical decisions – such as changes to medication, AE/SAE review – continue to be the responsibility of the investigator/sub-investigator.
- The clinical trial protocol (or related documentation) must predefine and describe an effective system of timely communication between the investigator/sub-investigator and “Home Care” staff ensuring that the investigator is informed about the completed visits in a continuous and timely manner (particularly in terms of trial subject safety – e.g. SAE occurrence and timely reporting by the investigator to the sponsor).
- The procedures conducted within the scope of “Home Care” must be adequately documented and the relevant source documents must be stored as part of source documentation of the clinical trial kept by the investigator at the trial site and investigator's supervision must be documented (the investigator shall forthwith review records from “Home Care” visits and attach his/her signature on the source documents as confirmation that the review was completed).
- The “Home Care” staff who are to be involved in the clinical trial in question must be engaged as external co-workers of the study team, i.e. they must be included in the Delegation Log, including their responsibilities and competencies, documented qualification, completion of training by the investigator/sub-investigator in the activities they are to perform.
- “Home Care” must be covered by the insurance of the clinical trial.
- The “Home Care” provider cannot be engaged by the sponsor; the sponsor shall pay for “Home Care”, but there must be a written contract between the provider of the healthcare services where the concerned trial site is located, and the “Home Care” provider. Such contract must specify the responsibilities and competencies of the “Home Care” provider in the clinical trial, and also a list of names of “Home Care” staff to be involved in the clinical trial (may be included in the form of an annex). The listed staff shall be included also in the investigator's Delegation Log at the trial site.
- (Note: “Home Care” cannot be utilised for the purposes of administration of products to be applied under the supervision of a medical doctor or by a medical doctor, after which the patient is to be followed up for a particular period of time (specified by the Protocol or by the SmPC, e.g. for 1-2 hours). “Home Care” cannot be utilised for the application of a phase II product where a first-in-man study is concerned).
Department of Clinical Trials on Medicinal Products
Date: 13 May 2020