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Investigational sites’ readiness to support new monitoring initiatives such as risk-based monitoring and centralized monitoring will dictate their success. Here are key aspects that sponsors and CROs should establish with investigational sites while implementing these new initiatives.
The success of new monitoring initiatives like risk-based monitoring (RBM) or centralized monitoring also depends on the investigational sites’ readiness to support these new approaches. Risk-based monitoring or centralized monitoring is all about identifying risks upfront, monitoring them based on the data coming from the sites and then taking proactive measures to control, and mitigate those risks or issues, which involves effective and timely support from the investigational sites. As investigational sites are the important stakeholders in these new monitoring methodologies, sponsors and CRO need to ensure that proper understanding and training should be given to the sites while implementing new monitoring approaches to their studies. Sponsors and CROs also need to understand how the site role is changing while monitoring, mitigating, controlling risks/issues related to data quality, patient safety, timelines and budget.
Some of the key aspects that sponsors and CROs should ensure with the investigational sites while implementing these new monitoring initiatives are mentioned below.
Site Identification & Qualification Process
During this process, the sponsors/CROs need to discuss about RBM/centralized monitoring approach that they would be implementing for the study and how the sites’ role and responsibility would differ for some of the activities over the traditional method. The sites’ comfort level and capability should be assessed for some important activities like timely data entry after patient visits, support for remote site management activities, timely implementation of corrective actions suggested remotely by the sponsor/CRO, reduced number of on-site monitoring visits, sending additional information as needed, and commitment for these key activities. The relevant questions and points should be added in feasibility questionnaires and site qualification visit reports to assess the sites’ willingness to support these new monitoring initiatives.
Timely Data Entry in EDC
Data coming from the sites on timely basis is essential for centralized monitoring and forms the core of RBM. As risk reports or KRIs are monitored during centralized monitoring, it should be agreed in the beginning between the sites and sponsors/CRO how many days after patient visit data will be entered in the EDC. The earliest timelines like data entry within three days after patient visit would be better to get close to real-time view of the study and patient status at the sites. Based on the planned patient visits based on the schedule of events, the sponsor/CRO can have a mechanism in place to follow up with the sites to ensure the EDC data entry is on time. Also, adopting a site payment approach based on patient visits and corresponding EDC data entry will further facilitate this activity.
Remote Site Management/Monitoring
As new monitoring initiatives recommend reduced number of on-site monitoring visits and most of the issues that arise during centralized monitoring would be managed by remote site contacts, the site personnel should be supportive and available on-call to facilitate proactive or corrective and preventive actions based on those risks or issues. They should be comfortable, trained and prompt in implementing changes or corrective action if required based on telephonic discussion or remote contact done by the sponsor/CRO. As per the traditional monitoring approach, sites personnel who are comfortable discussing issues during in-person visits can apply this same level of comfort to new remote monitoring practices. Sponsors and sites should identify the contact person(s) upfront and this role should be documented in site responsibility log.
As new monitoring initiatives lead to reduced number of monitoring visits, some sites may express concern over the quality of study conduct and data quality-especially with their less experienced personnel. These sites should be trained and encouraged to support and manage the risks/issues through telephonic contact or other remote site management activities. It should be clearly explained during site qualification and site initiation visits the objectives of on-site monitoring visits with these new monitoring methodologies, what activities will be performed and what would be planned frequency of visits. Also, the possible reasons for conducting additional visits to the sites should be explained to the sites.
Adequate Training to Sites
The site staff should be given relevant adequate training to support RBM or centralized monitoring approach and ensure complete compliance related to protocol, GCP and regulatory requirement.
Change management while implementing RBM or centralized monitoring requires adequate attention to process re-structuring, training, and technology requirements. Sponsors and CROs should examine their role in keeping sites ready, trained and prepared to implement new monitoring initiatives to their clinical trials. The investigational sites play a crucial role in effective implementation of RBM or centralized monitoring.
Ashok Ghone, Ph.D. is Vice-President, Global Services at MakroCare USA. He has around 20 years of experience in pharmaceutical and clinical research industry. He carries good knowledge & understanding of global clinical research with hands-on experience in clinical operations, project management, clinical trial management, process development, site management and patient recruitment activities. He has led various cross functional teams successfully by providing strategic direction, guidance for accomplishment of local, regional and global projects involving early & late phase clinical studies in various therapeutic areas. Ashok has been involved in development of process, system and training related to risk-based monitoring and centralized monitoring at MakroCare, which offers these specialized services to biopharmaceutical & medical device companies to support their endeavors in implementation of RBM approach. Email: firstname.lastname@example.org