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Monitoring in medical device studies: what is needed?

If you are a manufacturer who started a clinical trial, then you have the obligation to adequately monitor the study (MDR Article 72, par. 2; ISO 14155:2011). Monitoring is the act of overseeing the progress of a clinical investigation and to ensure that it is conducted, recorded, and reported in accordance with the CIP, written procedures, Good Clinical Practice, and the applicable regulatory requirements.

How much monitoring is needed must be determined by the sponsor: you, the manufacturer who takes responsibility and liability for initiating and managing the study and arranging its finances. The extent and nature of monitoring required must be based on the study objective and methodology and how much the intervention deviates from normal clinical practice (MDR Article 72, par. 2). In practice, the monitoring rationale follows a risk-based approach (following the principles of ISO 14971 on risk management for medical devices). The monitoring plan is part of the study plans and must be drawn up before the study is started. The monitoring plan is either integrated into the Clinical Investigation Plan (CIP) or documented as a separate monitoring plan (with rationale, summary, and reference to the plan in the CIP).

The actual monitoring is done by a monitor / Clinical Research Associate (CRA). CRA’s often have an educational background in life sciences - nowadays often a graduate degree - and they are familiar with medical terminology. The monitor must be trained on the protocol, the device, the sponsor’s relevant standard operating procedures and Good Clinical Practices (preferably ISO 14155 GCP). The monitor should follow the monitoring plan that has been drawn up by the sponsor. The investigator at the research site has the obligation to provide the monitor access to the records and to facilitate monitoring visits.

These are the types of monitoring visits that are routinely performed for clinical studies:

Site selection visit (also called feasibility visit, assessment visit, or qualification visit): this is a pre-study visit by the monitor and often a senior member of the project team. In its simplest form, this visit is to have initial discussions with the investigator on possible study participation (often remotely). In its most advanced form this is an on-site visit of several hours during which the capabilities of the site are assessed in detail with the goal of formally qualifying the site for study participation. In the latter case, a detailed visit report will address -among many other items- site recruitment procedures, qualifications and availability of site personnel, storage facilities for investigational devices, publication expectations of the investigator, etc.

Site initiation visit (SIV): an initiation visit for each participating investigation site or, alternatively, an investigator meeting shall be conducted and documented by the sponsor at the beginning of the clinical investigation (ISO 14155). The initiation visit is usually a 4-8 hour visit during which the site receives final training by the monitor on the CIP, Investigators Brochure (IB), Informed Consent Form (ICF) and procedures, Case Report Forms (CRF), Instructions For Use (IFU), and any other procedures and agreements. Often a recap of GCP principles or a GCP refresher training is done and documented. The monitor does a final check on the availability and completeness of all study documentation, investigational devices and the Investigator Site File (ISF) on site. After the initiation visit, the site should be ready to start enrolment.

Interim monitoring visits (IMV) (also called routine monitoring visits): these are on-site visits of one or multiple days during which the monitor primarily performs Source Data Verification (SDV). The goal of SDV is to verify that data entered by the site on the CRFs corresponds to the medical records of the patients in the hospital. Note that the monitor can only access patient files when these patients have provided consent. Therefore, the monitor should first verify that the consent process has been followed and that a signed consent form is available for each study subject. The monitor will further verify whether the regulatory approvals are in place and the investigator site file is up to date. The monitor will review important study logs such as the delegation of authority log; training logs; device accountability log and visit logs with the goal of verifying that the study is conducted in compliance with the protocol and by adequately trained and qualified personnel. The monitor closely collaborates with the site study coordinator (or research nurse) and will usually have a brief meeting with the principal investigator to discuss the results of the visit and any findings. Results of the monitoring activities are documented in detail in visit reports for the sponsor. A follow-up letter summarizing the visit outcomes will be shared with the site.

Site close-out visit (COV): after the last visit of the last study subject and when follow-up is completed, the monitor should conduct a close-out visit. This visit usually lasts about half a day during which the monitor ensures that all site records are complete, all documents that are needed for the sponsor’s file are retrieved, remaining clinical investigation materials are disposed of or returned to sponsor, and any previously identified issues are resolved and all parties notified.

Conclusions

In principle, monitoring should occur before, during and after a study. It is an expensive commitment, taking between 10-40% of the cost of a clinical investigation. However, site monitoring will greatly improve data quality, compliance and safety. And lastly, monitoring is required to comply with GCP and MDR requirements on clinical investigation conduct.

How can Qserve help you

Qserve CRO offers monitoring services for your clinical investigations. We work with in-house monitors and trusted local monitors (depending on the country). All of our monitors have experience with medical device studies. We can support all sorts of study designs in all development phases and offer efficient monitoring for post-market clinical follow-up (PMCF) studies and other forms of data collection. Contact us for more information.

Wiebe Postma, PhD
Datum der Veröffentlichung: September 25, 2019
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