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04/04/2016 at 8:12 pm #4612KathrineMember
I am interested to learn from others who work at more mature clinical trial sites how they staff their stakeholder engagement work; their GPP work; their community engagement work. I am wondering what human resources a clinical trial site devotes to this work and how much such positions overlap with other responsibilities versus being 100% positions. The more specifics you can share, the better. I am asking this to inform my budget requests to trial sponsor for funding such positions. Thanks in advance. – Kathrine
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07/03/2016 at 9:09 pm #5461BamideleMember
This is one challenge we have been having too. But twith the knowledge I have gained from this course, I can say that budgeting for GPP and research team members to take this responsibility plus their role in the research activity should be based on the the scope of engagement and the various types of GPP activities to be carried out. The PI needs to know more than 70% of these activities and cost them ab initio.
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07/02/2016 at 6:38 am #5458FaneleMember
Hello, community engagement staff does other tasks as well, research assistant responsibilities. They track participants who have missed appointments, remind participants of their scheduled visits and collect locator information during screening visits. There is no or little budget that is allocated to community engagement/GPP unless that site has sourced funding to implement GPP.
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07/01/2016 at 1:30 pm #5453LarissaMember
Hi Kathrine,
The staffing depends on the size of the community. We have at our research centre a community team of 3 staff members, 1 CLO and 2 Recruiters, but when we have big activities the entire research team helps; doctors, nurses, counsellors, etc. Some news on research just has to come from a more educated staff member, like a doctor. And at the end all staff members are responsible for recruitment and retention, so even if the Retention Officer is not able to reach a participant, but she’s a neighbour of a colleague, the colleague can make an effort to get hold of the participant as well!
For us it’s important that most of the staff (especially the community team) is coming from the area, as they know best how things work around here.
At the end, the community team should have an excellent relationship with stakeholders and CAG-members or other stakeholders can help as well with hosting events or setting up community dialogue sessions. Our sponsor even decided to hire 3 advocacy groups in the community, who organise events where the community team can go to present on the study. This is a nice booster as well for small organisations in the community.
I wish you all the best and hope you’ll get enough funding for a strong community team for your research, as it’s not a task you can easily combine with the clinical flow to obtain data…
All the best!
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05/13/2016 at 11:21 am #5046MarieMember
We have different form of stakeholder engagement, both formal and informal. Smaller groups include general discussion where we are more inclined to brainstorm. As a follow up to that we have strategic planning meetings where we put pen to paper and implement our plans and ideas. Having a retreat with various stakeholders and including them in presentations worked wonders and creates the right kind of space for dialogue
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05/13/2016 at 10:36 am #5045AnthoniaMember
In my team we have a stakeholder engagement group but the PI encourages every member of the research team to support the stakeholder engagement group so all of us in the team join hands to make our stakeholders happy though the budget is not robust.
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04/22/2016 at 11:08 am #4844MarieMember
Katherine, my take on this is that staff are part of our stakeholders and together with non -affiliated stakeholders lap over should not be burdensome because if the stakeholders who are not part of the site staff are the ones who represent the larger group in terms of decision making, voting and representation, they would be speaking for ALL, on a more impartial point of view without the problem of conflict of interest, however, stakeholders who are employed at the site may be bound by a staff site SOP that requests that they abstain from certain processes in the interest of impartiality and thus enabling them to balance their work and roles as stakeholders. Our site has a conflict of interest document which is signed on an annual basis by site staff and kept for record purposes
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04/18/2016 at 1:27 pm #4793PhumezaMember
In our site we have a team GPP team that oversee the community engagement of all the projects that are currently going on. This team consist of the Community technical head, Gpp manager and the Community project coordinator, then we support the Community health workers and the Community liaison officers for each project. Im not sure if this will work on your site.
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04/18/2016 at 7:51 pm #4796KathrineMember
Thank you Phumeza, that is very helpful. As we only have one trial coming down the development pipeline for now, it may be hard to advocate for such a robust team. On the flip side, given how little work has been done to date, we arguably need to devote more efforts to this. It is very helpful for me to have your example, and others (keep them coming!) to use as concrete talking points for my discussions and negotiations with the sponsor. Thank you.
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04/13/2016 at 4:19 am #4753Mahesh RamraoMember
I am not involved in clinical trials but I agree with Mark and James, to recruit dedicated, knowledgeable, and trained staff we requires strong funding. Stakeholders are engaged in research only when they were made financially happy.
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04/12/2016 at 6:54 pm #4748MosesMember
Mark and James, you are right. Without stake holders, a trial can hardly succeed. Grant makers should find ways of making stakeholders ”happy”
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04/12/2016 at 2:02 pm #4742JamesMember
Well, I might not be so involved in some clinical matters regarding staffing but I believe GPP stakeholder work is really underfunded, I believe some more advocacy push need to put forward to achieve support. Quite agree with Mark
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04/07/2016 at 2:41 pm #4689MarkMember
I think this is always a challenge. Most often in my setting, these efforts are covered by a partial allocation of a person’s time. They are often underfunded. Strategically, I think we must advocate that grants allocate specific and sufficient resources for these efforts and that those resources manifest themselves at the point of implementation in actual effort / outcomes.
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