As known, we expect the JCI accreditation for Amsterdam UMC from September 26th to October 7th.

Standards for research involving human subjects are described in a JCI specific chapter called Human subjects Research Program (HRP).

What to expect:
During patient tracers the primary focus will be on general JCI standards, but also expect some research related questions on subjects touching the overlap between care processes and clinical research processes, for example:

recognizing a research patient in Epic / safety reporting / study medication / training and skills of research personnel.

So, how to be prepared?

  • Know your responsibilities
    Implementing and complying with the policy and standard operating procedures (SOP’s) for research involving human subjects rests with the heads of department (mandated by the Executive Board) and Principle Investigators (at study level). PI’s delegate their research personnel on the Site Signature and Delegation Log, make sure they’re trained properly and this is documented.
  • Know that also for researchers the general JCI standard are applicable
    For example general safety, proper storage, International Patient Safety Goals etc.

  • Know the 4 most Q&A's
    1. Do you know how to report an SAE? If the SAE also meets the definition of an incident, do you know what to do? Can you show me?

    How to report SAEs is described in the approved study protocol. This is usually a standard procedure and done via ToetsingOnline (or CTIS in case of trials with medicinal products under the EU Clinical Trial Regulation). The reoprts go to the medical ethics committee and the CCMO (Dutch Central Committee on Research Involving Human Subjects).

    Adverse events in research can at the same time meet the criteria for (near) incidents or calamities in Amsterdam UMC. Reporting incidents is part of the integral quality system. Incidents are reported via the Safety Management System: I-Task. The link can also be found on the homepage of both locations. For definitions, instructions on reporting (near) incidents, see the manual in K2.

    2.    Which responsibilities do you have within research? And within a specific trial? Which training requirements and skills are required? How is this documented? Can you show me?

    According to our Research Policy, based on the NFU guidelines, all clinical investigators must have a BROK certificate and other study personnel must be trained in GCP guidelines appropriate to their study activities. Certificates can be found in the BROK register, on a person’s CV or in the study file.

    Who is delegated to perform certain study activities can be found on the ‘Site Signature and Delegation Log’.

    Study specific training you’ll find on a training log (e.g. who has been trained in which version of the protocol or a study specific procedure).


    3.How can your colleagues recognize in Epic that their patient is also a participant in a trial? Can you show me?

    When you link a research participant to the specific trial in Epic, an Erlenmeyer flask will be visible for your colleague in the file of that patient in Epic. If they click on the flash the name and contact information of the PI will appear and some additional information on the study.


    4. Do you know where you can find policies and standard operating procedures regarding research involving human subjects? Can you name the most relevant documents and/or can you show me were to find them?

    Research policies and operating procedures are kept in our Document Management System (i-Prova). Easier is to go to the policy framework tab on this website, there is a tab with references to the most recent version of all policies and SOPs in i-Prova.

    You’ll find the following research policies & procedures you should recognize:

    -Research Code

    -Research Policy on scientific research involving human subjects

    -GCT SOP 01 Informed Consent Procedure

    -GCT SOP 02 Reporting deviations & escalations in research involving human

    subjects

    -GCT SOP 03 Filing of essential documents in research involving human subjects

    -GCT SOP 04 Safety reporting in research involving human subjects

    -GCT SOP 05 Central Data Safety Monitoring Board

Questions?

E-mail team Quality Assurance for Research: teamkwaliteitklinischonderzoek@amsterdamumc.nl