Background
One of the goals of the REDe network is to support the conduct of high quality research by providing tools, training and guidance in all the elements that are required. A very fundamental, but often overlooked, piece in this is the planning and implementation of research quality management (which is often referred to as monitoring). The purpose of this is to ensure the following;

1. That the study is conducted according to the protocol
2. That the study SOPs are followed (and so helping achieve 1)
3. That the ethical rights of the participants are being considered and protected
4. That the study is being conducted safely
5. That the data is being recorded and transcribed accurately.

This guide will set out why quality management and monitoring is important and how it can be easily and practically built into a study. Also, this document will explain how this process should be proportionate to the complexity and risks associated with the study and so should be appropriate as well as being highly practical and achievable.

All studies on human subjects should have an assured level of quality to protect the rights of the participants and to ensure data are reliable. This is not just important for those taking part in the research but for every future patient whose treatment has been determined by the results. All clinical research should be run to ICH-GCP standards; however, ICH-GCP was designed by industry and FDA primarily for new product registration and is therefore often difficult to apply to other more pragmatic trials on registered products or non-drug trials, and indeed observational or sampling only studies. Trial monitoring and quality assurance is often perceived as difficult as many people experience has been classical industry drug monitoring. This is more than is needed for an observational study as the protocol is straightforward and the risks are very low. However, as with any research it is still very important to confirm that the data is correct and reliable. This can be done easily and made into an integral and beneficial part of study operations. This guidance paper sets out several ways this can be achieved, using an obeservational study as an example.

Quality Management Plan for Observational Studies

Step One.
The first step suggested is for each site to write a simple and pragmatic quality management plan. Appendix one provides a guideline and template for this and appendix two is a more detailed example. This could be done by individual investigators or in a group, as long as the specific detail is appropriate for the sites. The aim should be to establish a positive and simple process that brings broad benefit and establishes quality management as a normal and integrated part of how the site operates. The aim of this step is for each site to have in place a straight forward operational plan that will confirm data reliability and high ethical practice

Step Two
Who will be confirming that this quality management plan is being implemented? We suggest that each site nominates a quality manager or officer (or whatever term they wish to use). Ideally this should be an experienced member of the research team. They might be a clinician, a nurse, a laboratory technician – anyone who is valued, appropriately experience and interested in taking on this important extra role. They do not need to have any previous experience in monitoring or quality management. Where this system has been implemented successfully in other sites this has worked well when it is seen that this is a job enhancing role and that being offered this is a reward and recognition. It has been a useful way to extend staff’s experience and give their job an extra dimension. It is important that this role is viewed positively and that the person taking it on is clear about the remit and motivated in the task. Once this has been decided the specifics of what they will review, where and how often will all be recorded in the plan (as explained in the appendices). The review and reporting process should also be carefully considered and captured in the plan.

Step Three
Potential of extending to reciprocal monitoring. Once training has been conducted (see below) a good starting point will be for the quality managers to begin by performing quality management ‘visits’ at their own sites, putting into practice their training and testing out their quality management plans (which of course should be amended and updated as needed). A beneficial next step to further enhance quality management and increase credibility would be to set up a reciprocal system. Here quality managers from within the network monitor each other’s studies. Where sites in Africa have used this approach they have experienced wide reaching benefits such as sharing best practice and standardisation. Staff reported really benefiting from visiting each other’s sites and broadening their experience. In this case it might work within countries, so a scheme could be established for this within the region.

Next Steps
Training would be helpful in both setting up and then implementing a quality management plan, whether quality management is performed at an in-house level or if this is extended into a reciprocal scheme in one or more of the countries within the region. This can be organised through the REDe network and there are many resources such as online training, materials for classroom based training and a workshop toolkit. It may be possible to send an experienced monitor or trainer to your site to deliver a workshop or teaching session, or this could be set up on line. Please get in touch through the REDe website. When sites have nominated a quality manager we will also link them together and this can form a supportive community of practice where ideas and approaches can be shared.

Typical training courses (virtual or face to face) would encompass the following;

  • Review and development of draft quality management plans (so sites would bring their draft versions)
  • Basic GCP
  • Introduction to quality management for clinical research
  • How to conduct a quality management visit
  • How to report a quality management visit
  • Processes for handling any issues to be reported

Coordination is important, especially in large and collaborative studies where data it to be pooled. Whether sites remain with the in-house system or move to a reciprocal scheme within countries (or a mixture of both is perhaps the most likely outcome?) here coordinating information exchange on quality management across the region would really help make this a success, and this can be facilitated on the REDe platform. This will involve the following;

  • Support and review of quality management plans
  • Review and support with quality report visit (and implementing any actions)
  • Coordination of any reciprocal schemes
  • Coordination of training
  • Implementing an evaluation process for both in-house and reciprocal schemes.

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