Clinical exams in practice - monitors chat out of the sewing box

At MedxTeam, the focus is on clinical data. In this context, as CRO, we not only carry out clinical tests (studies) with medical devices in accordance with MDR and ISO 14155, but also offer support in the area of ​​monitoring required in accordance with the GCP. In this article, we explain in this article what is important both on site and in the context of remote monitoring and which pitfalls are possible.

Abbreviations

GCP Good Clinical Practice

MDR Medical Device Regulation; EU Regulation 2017/745

Underlying regulations

EU Regulation 2017/745 (MDR)
General Data Protection Regulation (GDPR)
Medical Device Environmental Constitution (MPDG)
ISO 14155

1 Introduction

Clinical exams are an essential part of medical research and development. They make it possible to test new therapies and medication for their effectiveness and security before they are made accessible to the general public. Monitoring is a crucial factor for the success of such studies. Monitors play a central role in ensuring the integrity, security and reliability of the studies. In this blog post we take a look behind the scenes and shed light on the pitfalls that can occur during monitoring clinical exams. We will discuss the most important points that should consider monitors to ensure a successful implementation of the studies.

2. What should be considered in the on-site monitoring?

2.1 Communication

Good communication is the be -all and end -all for the success of every clinical examination. Monitors must ensure that smooth communication between the sponsor, the study team and other participants, such as Contract Research Organizations (Cros), is guaranteed. Regular meetings and reports on the progress check are essential to keep everyone involved on the same stand and to recognize and remedy possible problems at an early stage.

Ensuring good communication:

• Regular meetings: These should take place both personally and virtually to ensure that everyone involved is informed and involved. Personal meetings make it possible to discuss complex topics in detail and avoid misunderstandings. Virtual meetings offer flexibility and enable more frequent communication, which is particularly advantageous in international studies.
• Reports on the progress check: These reports should be created in detail and regularly in order to document the current state of the study and to ensure transparency. You should contain information about the progress of the study, problems that have occurred and their solutions as well as planned next steps. Clear and precise reporting helps to keep everyone involved on the same stand and to maximize the efficiency of the study.

2.2 Preparation

Thorough preparation is the key to success of every monitoring activity. Monitors should ensure that all necessary steps are taken in advance to ensure a smooth process. This begins with the early sending of a confirmation letter and ensuring that all relevant people and data are available.

2.3 Equal sending a confirmation letter:

• Appointments: It is important that all relevant people of the study team are present. The duration of the visit should be assessed in advance and communicated. This enables efficient planning and ensures that all the necessary information and resources are available.
• Access to the patient and studies data: Monitors must ensure that you have access to all the necessary data in order to be able to carry out your tasks effectively. This includes both physical and electronic data. A smooth access to the data is crucial to avoid delays and ensure the accuracy of the checks.

2.4 Current status of the study:

• Relevant studies documents: Monitors should make sure that all relevant documents, such as the test plan and patient information, are up to date and meet the latest requirements. This also includes checking whether all documents are completely and correctly filled out. Thorough preparation helps to identify and remedy possible problems at an early stage.

2.5 Ensuring compliance

Compliance with regulations and legal requirements is of the greatest importance for the integrity of a clinical examination. Monitors must ensure that the study is carried out in accordance with the Ich-GCP guidelines and other relevant regulations. This includes the review of permits, training and the accommodation of the study material.

Check the compliance:

• Approval: Monitors should check whether the study was approved by the responsible authorities and ethics commissions. This is a crucial step to ensure that the study meets the legal requirements and is ethically justifiable.
• Training of the study team: It is important that the study team is trained accordingly and has access to all relevant documents. A thorough training ensures that the team understands the requirements and protocols of the study and implemented it correctly.
• Accommodation of the study material: All study documents should be kept safely, e.g. in closed cupboards. Test material that has to be stored chilled should be accommodated accordingly. Proper storage is crucial to ensure the integrity of the study materials and minimize possible risks.

2.6 Patient safety

The safety of the patients is the top priority for clinical exams. Monitors must ensure that all patient information is correct and complete and that all safety precautions are observed. This includes reviewing patient information and documenting serious undesirable events (Saes).

Ensuring patient safety:

• Patient information: Monitors should check whether all patient information is correct and fully signed. A comparison with the screening and patient ID lists is essential. This helps to confirm the identity of the patient and ensure that all the necessary consent is available.
• Documentation of (s) aes: All serious undesirable events (Saes) must be documented correctly and transmitted. Monitors should ensure that they are complete. Thorough documentation is crucial to ensure the safety of the patients and to recognize and remedy possible risks at an early stage.

2.7 Data accuracy and completeness

The accuracy and completeness of the data is crucial for the validity of the study results. Monitors must regularly check the entries in the clinical databases and ensure that the study data match the source data. This includes remote monitoring and source data verification on site.

Review of data accuracy:

• Remote monitoring: It is often possible to check the entries in the clinical databases remote. This offers flexibility and enables the data to be checked more frequently.
• Source Data Verification: When monitoring on site, the study data should be compared with the source data. It must be ensured that all deviations from the protocol are documented. A thorough review of the source data helps to ensure the accuracy and completeness of the study data and to identify and remedy possible errors at an early stage.

3. Remote monitoring in practice:

Remote monitoring enables data to be checked regardless of location and regularly check the quality of the entries. The focus is on completeness, traceability and plausibility of the registered information. In practice, however, it often shows that data is entered incomplete or late. This can endanger data integrity and delay the analysis.

A functioning flow of communication between the monitor and the team of studies is therefore essential - especially if you have any questions or indications of data gaps. Unfortunately, the activities carried out in Remote are always clear that information losses or delays occur here. Clear responsibilities, timely reactions to queries and a structured data flow help to avoid these pitfalls.

• Remote monitoring can be enormous relief - but only if it is well integrated into the total processes of the study.

3.1 m ontitoring in times of increasing digitization

With progressive digitization, the requirements for monitoring are also changing. Electronic documentation, econsent procedures and decentralized forms of study present monitors with new challenges-but also offer opportunities. Stronger IT affinity, a good understanding of digital workflows and the ability to effectively communicate remote are increasingly becoming core competencies.

3.2 Study documentary

A complete and current documentation is essential for the success of a clinical test. Monitors must ensure that all essential documents in the Investigators File are complete and up -to -date. This includes the regular review and update of the documents.

Checking the study documentary:

• Essential documents: Monitors should regularly check whether all the necessary documents are available in the Investigators File and are up to date. Thorough documentation is crucial to ensure the integrity of the study and to recognize and remedy possible problems at an early stage.

4. Case stricken in monitoring

Despite careful planning and implementation, various pitfalls can occur during monitoring clinical tests. These can endanger the integrity and success of the study if they are not recognized and remedied in time.

This includes, for example, the following points:

Source Data:

Incomplete documents: very often the documents for visiting monitoring are not complete. Sometimes they are only taken care of during the visit, which is very time -consuming. It has already happened that patient files have been outsourced and this has not been communicated. This leads to considerable delays and makes it difficult to check the data.

Relevance of data: Often in the protocols it says "relevant" in relation to pre -medication, previous illnesses etc. This "relevant" can of course be interpreted very stretchy and often leads to discussions with the Principal Investigators (PIS). A clear definition and communication of the relevant data is crucial to avoid misunderstandings.

Small organizational problems: it often hooks on "small" things, such as the abbreviation and evaluation of study examinations (laboratory, EKG, etc.). This seems to be an organizational problem at some centers. The Study Nurse "runs" behind the doctors to get this task that is actually not particularly difficult. Better organization and clear responsibilities could help here.

Organization at the study center / studies:

Overload of the staff: Unfortunately, it is almost the rule that the study coordinators and Study Nurses are too overloaded. It doesn't seem to be clear to the PIs how complex a study is. The same often applies to the sub-investigators, who are "listed" in addition to their other tasks. This leads to poor compliance and incomplete source data.

A lack of seriousness: Sometimes I have the feeling that studies "are not taken seriously". This is something that can run on the side. Of course, this is not true and leads again to poor studies and incomplete source data. A clear communication of the importance and requirements of the study could help here.

Cumbersome and bad data systems:

Undisputed E-CRF: At the moment I have a study that is managed with a very "unadulterated" E-CRF. The E-CRF is cumbersome and confusing for Study Nurses and Cras. This often leads to unnecessary queries and both center staff and cras are annoyed. A better design and user -friendliness of the data systems could help here.

Query resolution:

Long duration: The solution of queries usually takes too long. This is often due to the problems mentioned above. A faster and more efficient solution from Queries is crucial in order not to hinder the progress of the study.

5. Conclusion

Monitoring clinical exams is a demanding and responsible task. Monitors must take a variety of aspects into account in order to ensure the integrity, security and reliability of the studies. Good communication, thorough preparation, compliance with regulations, ensuring patient safety, checking data accuracy and complete documentation are crucial. By observing these points, monitors can help to successfully carry out clinical tests and to deliver valid results.

6. How we can help you

We are happy to support you with regard to the structure and implementation and use of a database -based system. As Cro, we also take over the complete data management via the EDC system and monitoring.

So we support you during your complete project with your medical device, starting with a free initial consultation, help with the introduction of a QM system, study planning and implementation to technical documentation - always with primary reference to the clinical data on the product: from the beginning until to the end.

Do you already have some initial questions?

You can find free initial consultation here : Free initial consultation