Why Pragmatic Monitoring and Quality Management Systems Are Needed
There has been a trend over recent years towards the use of expensive contract organisations to monitor research studies and this can be expensive and is not necessary. As an academic clinical research facility the KEMRI-Wellcome programme in Kenya needed to find an optimum way to monitor all their studies to ensure adherence to the protocol, that high ethical standards were being maintained and that the data was being accurately captured.

Monitoring should be a helpful and fundamental part of a clinical research study. It is not an 'audit' but an ongoing process of working with the research study team to help achieve compliance to the protocol and standard operating procedures (SOPs). Another fundamental object of monitoring a study seems to be less often applied. This is the need to ensure that the question set is being answered and that the answer can be relied upon. It is possible that many clinical research study’s produce answers that are either a false positive, false negative or false no difference. This is worrying as new and changes to treatments are driven by such data, and usually that false results (especially if they are negative) never come to light. Whilst such errors might originate from the design or power of the study, these flaws might not be possible to predict until the study is running. Often it is not possible to account for all eventualities when designing research studies and statistical plans are then based upon assumptions, Therefore once the research study is running it is necessary that the monitors have a cognitive role as they need to be constantly thinking about whether any process or issues could impact the reliability of a study endpoint, This is the light in which we insist that the monitor should be familiar with the protocol and their role is far more that passively checking that text boxes are filled.

Monitoring need not be an arduous general task, but it should be commensurate with the risks and complexity of the research study. ICH GCP (5.18.3) requires the sponsor to ensure that the research study is adequately monitored. “The sponsor should determine the appropriate extent and nature of monitoring which should be based on the considerations such as the objective, purpose, design, complexity, blinding, size, and endpoints of the research study. In general there is need for on-site monitoring, before, during and after the research study; however in exceptional circumstances the sponsor may determine that central monitoring in conjunction with procedures such as investigator’s trainings and meetings, and extensive written guidance can assure appropriate conduct of the research study in accordance with GCP”

Introduction to Reciprocal Monitoring
When the Reciprocal monitoring scheme was devised in 2007 The KEMRI-Wellcome centre had more than 15 year’s experience in conducting clinical studies ranging from large pharmaceutical initiated (and sponsored) regulatory research studies to small academic/investigator-sponsor research studies. As part of ensuring GCP for their trials the team were faced with the challenge of ensuring that all our clinical research studies are adequately monitored. The CRO model was unattractive because of the cost and their non-protocol specific approach. Therefore, Trudie Lang, the Head of Clinical Trials in Kilifi at that time, designed a scheme to harness the experience of the study coordinators and nurses and train them to be study monitors, within their day-to-day roles.

The scheme that Lang set up was an in-house system where clinical research study staff were trained as research study monitors and then monitor studies of which they are completely independent. This system has since been replicated in many setting and has been reported to raised standards across all research studies (as it created a platform for sharing best practice), increased the profile of research study staff and has been well received by investigators, sponsors and research study staff teams (Chilengi, Chantler). Overall a site mentoring rather than monitoring approach is well accepted and supports the aim of conducting high quality clinical research in accordance to the international conference on harmonisation of Good Clinical Practice (ICH GCP) and is also highly pragmatic and inexpensive.
This team found that training some of their staff for monitoring, and then monitoring each other’s studies is a mutually beneficial exercise for the study monitored and the individual monitors. The basic principles of clinical research study conduct are generic and applicable across studies. The process of developing monitoring tools, training and management of the monitors group has turned out to be a highly rewarding experience to the monitors cum coordinators. This cadre of staff has become the key implementers and driving force of GCP. With a pool of at least 20 trained monitors, they managed to allocate at least two monitors to each study. Thus all studies are similarly monitored and reported to the head of clinical research studies and respective principal investigators.
In Kenya the research study investigators, sponsors and funders report to be impressed and satisfied with the monitoring that the research studies have received. Before this scheme was implemented only the externally sponsored drug development research studies were monitored. Presently all clinical research studies in the programme are subject to the in-house reciprocal monitoring scheme, even if they are also externally monitored by the sponsor. Previously many of our locally sponsored or academic research studies were not able to finance monitoring (as CRO’s would have been the only option) and they did not have the skills or capacity to monitor themselves. This reciprocal scheme has made quality and ethical standards assurance achievable and feasible.

This monitoring system became a popular activity within the KEMRI programme. This is because the staff reported that it bought an additional benefits of staff motivation and skill enhancement. The opportunity to train to join the monitoring pool allowed a research nurse from the ward, for example, to gain experience of clinical research studies in the community out in our field sites. Another good example is that spending two days a month monitoring research studies gives the research study laboratory staff, or the research study pharmacists, hands on experience of clinical research studies from a perspective they do not normally experience.
With this system, it was important to write and monitoring plan that reflected the nature of each study and so, for example included scheduling monitoring visits according to the complexity and risks of the research study. In the CRO monitored research studies, such decisions would normally heavily weigh on availability of finances rather than study designs. An additional benefit is that it creates an opportunity for mentoring of research study staff through continued interaction between the more experienced and lesser experienced research study staff during and after the monitoring activities. In the CRO model the amount of interaction would be limited to the resources available for on-site monitoring.

Benefits of setting up a Reciprocal Monitoring Scheme
A reciprocal monitoring scheme could be set up within any facility or organisation that runs several studies , be they in one location or many. The financial and wider benefits still hold even if travel costs are incurred. Any member of a clinical research study research team can train as a monitor. Nurses, data managers, pharmacists and research study coordinators all make excellent research study monitors. Research study monitoring can be built into people’s roles so they do not do this full time. This is a good way to give staff an extra dimension to their role and is an excellent continuous training experience. The training for these monitors can also be organized in-house (and so for relatively less cost), as long as sufficiently experienced and senior monitors/trainers are available. There is a plethora of expensive courses for research study monitors but nowhere in ICH GCP, or in any other regulations, are there specific requirements or certification for monitors – or their trainers. What can be found are statements around appropriate experience and qualifications. Here, as with monitoring itself, it seems that the commercial needs of training companies and contract organisation have created a market and a perceived need for external training courses, certification and accreditation. It is perfectly appropriate and acceptable for those with strong experience in monitoring to train others. Therefore, here, within the REDe platform the monitoring courses and materials, both online and face to face will be highly robust and valid.

 

Why Pragmatic Monitoring and Quality Management Systems Are NeededThere has been a trend over recent years towards the use of expensive contract organisations to monitor research studies and this can be expensive and is not necessary. As an academic clinical research facility the KEMRI-Wellcome programme in Kenya needed to find an optimum way to monitor all their studies to ensure adherence to the protocol, that high ethical standards were being maintained and that the data was being accurately captured.
Monitoring should be a helpful and fundamental part of a clinical research study. It is not an 'audit' but an ongoing process of working with the research study team to help achieve compliance to the protocol and standard operating procedures (SOPs). Another fundamental object of monitoring a study seems to be less often applied. This is the need to ensure that the question set is being answered and that the answer can be relied upon. It is possible that many clinical research study’s produce answers that are either a false positive, false negative or false no difference. This is worrying as new and changes to treatments are driven by such data, and usually that false results (especially if they are negative) never come to light. Whilst such errors might originate from the design or power of the study, these flaws might not be possible to predict until the study is running. Often it is not possible to account for all eventualities when designing research studies and statistical plans are then based upon assumptions, Therefore once the research study is running it is necessary that the monitors have a cognitive role as they need to be constantly thinking about whether any process or issues could impact the reliability of a study endpoint, This is the light in which we insist that the monitor should be familiar with the protocol and their role is far more that passively checking that text boxes are filled.
Monitoring need not be an arduous general task, but it should be commensurate with the risks and complexity of the research study. ICH GCP (5.18.3) requires the sponsor to ensure that the research study is adequately monitored. “The sponsor should determine the appropriate extent and nature of monitoring which should be based on the considerations such as the objective, purpose, design, complexity, blinding, size, and endpoints of the research study. In general there is need for on-site monitoring, before, during and after the research study; however in exceptional circumstances the sponsor may determine that central monitoring in conjunction with procedures such as investigator’s trainings and meetings, and extensive written guidance can assure appropriate conduct of the research study in accordance with GCP” 
Introduction to Reciprocal MonitoringWhen the Reciprocal monitoring scheme was devised in 2007 The KEMRI-Wellcome centre had more than 15 year’s experience in conducting clinical studies ranging from large pharmaceutical initiated (and sponsored) regulatory research studies to small academic/investigator-sponsor research studies. As part of ensuring GCP for their trials the team were faced with the challenge of ensuring that all our clinical research studies are adequately monitored. The CRO model was unattractive because of the cost and their non-protocol specific approach. Therefore, Trudie Lang, the Head of Clinical Trials in Kilifi at that time, designed a scheme to harness the experience of the study coordinators and nurses and train them to be study monitors, within their day-to-day roles. 
The scheme that Lang set up was an in-house system where clinical research study staff were trained as research study monitors and then monitor studies of which they are completely independent. This system has since been replicated in many setting and has been reported to raised standards across all research studies (as it created a platform for sharing best practice), increased the profile of research study staff and has been well received by investigators, sponsors and research study staff teams (Chilengi, Chantler). Overall a site mentoring rather than monitoring approach is well accepted and supports the aim of conducting high quality clinical research in accordance to the international conference on harmonisation of Good Clinical Practice (ICH GCP) and is also highly pragmatic and inexpensive. This team found that training some of their staff for monitoring, and then monitoring each other’s studies is a mutually beneficial exercise for the study monitored and the individual monitors. The basic principles of clinical research study conduct are generic and applicable across studies. The process of developing monitoring tools, training and management of the monitors group has turned out to be a highly rewarding experience to the monitors cum coordinators. This cadre of staff has become the key implementers and driving force of GCP. With a pool of at least 20 trained monitors, they managed to allocate at least two monitors to each study. Thus all studies are similarly monitored and reported to the head of clinical research studies and respective principal investigators.In Kenya the research study investigators, sponsors and funders report to be impressed and satisfied with the monitoring that the research studies have received. Before this scheme was implemented only the externally sponsored drug development research studies were monitored. Presently all clinical research studies in the programme are subject to the in-house reciprocal monitoring scheme, even if they are also externally monitored by the sponsor. Previously many of our locally sponsored or academic research studies were not able to finance monitoring (as CRO’s would have been the only option) and they did not have the skills or capacity to monitor themselves. This reciprocal scheme has made quality and ethical standards assurance achievable and feasible.
This monitoring system became a popular activity within the KEMRI programme. This is because the staff reported that it bought an additional benefits of staff motivation and skill enhancement. The opportunity to train to join the monitoring pool allowed a research nurse from the ward, for example, to gain experience of clinical research studies in the community out in our field sites. Another good example is that spending two days a month monitoring research studies gives the research study laboratory staff, or the research study pharmacists, hands on experience of clinical research studies from a perspective they do not normally experience. With this system, it was important to write and monitoring plan that reflected the nature of each study and so, for example included scheduling monitoring visits according to the complexity and risks of the research study. In the CRO monitored research studies, such decisions would normally heavily weigh on availability of finances rather than study designs. An additional benefit is that it creates an opportunity for mentoring of research study staff through continued interaction between the more experienced and lesser experienced research study staff during and after the monitoring activities. In the CRO model the amount of interaction would be limited to the resources available for on-site monitoring.
Benefits of setting up a Reciprocal Monitoring SchemeA reciprocal monitoring scheme could be set up within any facility or organisation that runs several studies , be they in one location or many. The financial and wider benefits still hold even if travel costs are incurred. Any member of a clinical research study research team can train as a monitor. Nurses, data managers, pharmacists and research study coordinators all make excellent research study monitors. Research study monitoring can be built into people’s roles so they do not do this full time. This is a good way to give staff an extra dimension to their role and is an excellent continuous training experience. The training for these monitors can also be organized in-house (and so for relatively less cost), as long as sufficiently experienced and senior monitors/trainers are available. There is a plethora of expensive courses for research study monitors but nowhere in ICH GCP, or in any other regulations, are there specific requirements or certification for monitors – or their trainers. What can be found are statements around appropriate experience and qualifications. Here, as with monitoring itself, it seems that the commercial needs of training companies and contract organisation have created a market and a perceived need for external training courses, certification and accreditation. It is perfectly appropriate and acceptable for those with strong experience in monitoring to train others. Therefore, here, within the REDe platform the monitoring courses and materials, both online and face to face will be highly robust and valid. 

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