groups » Trial Management » Internal Monitoring to Improve QA - tell me about your thoughts, ideas and experiences, please!
I am interested in peoples' ideas and experiences in in-house monitoring systems. This came up in our team meeting the other day, because we were looking at ways to improve our quality assurance processes and it was suggested by someone and seemed like a very good idea. I have read on this website about a group who have had sites monitoring eachother, but this would just be within our group but I want the whole group to be involved - and we want it to be supportive (a bit of a cross between mentoring and monitoring I supppose!).
We just really want to keep an eye on everything that we have going on, to ensure that we keep on top of small mistakes, to make larger monitoring visits more straightforward and to make audits and inspections less arduous. Also, I think it will be really beneficial for the group to work together if we can do so in a supportive way rather than a critical way.
I saw a blog on here about how QA can be improved and it inspired me to post to get the Global Health Trials community's input! I just wondered what others thought about this, whether people have tried it, how you went about doing so, and what worked and didn't work for you.
Thank you in advance!
I believe this is an important discussion as this is an area where people are confused. The 'traditional' monitoring model came from ICH-GCP and typically involved pharmacuetical companies monitoring the trials they they sponsor. This is the 'gold standard' from which all other approaches have evolved. Contract research organisation have grown over recent years and of course they are simply tasked by the sponsor to monitor their trials. It seems there is often a question or concern over schemes where sites monitor their own trials. This should be laid to rest because this is same as companies (sponsors) monitoring their own trials. An academic centre is often the 'sponsor' and therefore it is appropriate and indeed correct that they monitor their own trials. In my view it comes down to professionalism and the need to recognise trial staff for their roles and responsibilities and provide them with the professional support and mandate to be 'internal' or local monitors. The confusion over whether this is appropriate needs to be widely understood and recognised as being no different to the highly accepted and indeed standard practice of sponsors monitoring their own trials. The widespread use of CRO's has given the impression of 'independent' monitoring - whereas in fact it was no different as the sponsor was commissioning the CRO. The danger is that this becomes a commercially driven enterprise to perpetuate the myth that it is necessary to pay for an 'outside' organisation to monitor a trial. A monitor is someone who is well trained and professional and who can guide and support trial teams to ensure they are following the protocol, that data is being captured accurately and that the rights and well being of the participants are being protected.
Further to this interesting discussion, it is extremely valuable and sustainable to promote this arrangement of internally self-regulated monitoring of clinical trials, especially in resource-constrained settings of sub-Saharan Africa. It is more acceptable and affordable compared to the daunting sponsor or CRO arrangements (which are external to the setting) when promoting and propelling strategic quality management schemes for conducted health research in order to generate high-quality evidence for health policy and practice.
In Eastern Africa, this novel approach was ignited at Kilifi in Kenya Medical Research Institute (KEMRI) in partnership with the Wellcome Trust Research Programme as already published in peer-review journals by Dr. Roma Chilengi and Dr. Trudie Lang. The ‘infectious’ success story soon spread to Kisumu with KEMRI-CDC. It has now been scaled up to a regional reciprocal monitoring scheme with cross-site visits involving experienced clinical trial monitors paired with new/upcoming trial monitors for purposes of on-going mentoring and sharing of best monitoring practices. This scheme currently involves over 10 trials in the East African region and over 20 pooled regional monitors.
The interactions are more cordial/collegial than patronizing/intimidating, thereby creating an enabling learning environment for all parties involved as they share and exchanges their experiences across different trial sites in the region. This arrangement is also strengthening south-to-south and south-to-north networking. For instance, an upcoming monitor from Khartoum University in Sudan has been able to visit, observe and learn how to conduct trial monitoring visits in Kenya under guidance of an experienced monitor from Uganda. Now there is an independent assessor from the University of Oxford in UK who is conducting a participatory evaluation of this regional scheme for “value-addition” whilst comparing it with another similar scheme is South-east Asia. This is being handled in partnership with the World-wide Antimalarial Resistance Network (WWARN), the East African Consortium for Clinical Research (EACCR), the Global Health Trials and other key partners in Asia.
With more funding, this scheme is attracting more new/upcoming monitors in order to contribute an expanding critical mass of professionals in this important field to be safe-guards of high quality evidence from well conducted and monitored trials. It has the potential to retain such a skill-resourced group who can be approached to orient trial teams when new trials are rolled-out in Eastern Africa. Their visibility and impact will be strengthened further if more members of this group can access online accredited monitoring courses for more expertise, when additional funds become available.
For more details, you may contact the scheme co-coordinators:
a) Dr. Annet Nanvubya at Uganda Virus Research Institute (UVRI): (e-mail)- email@example.com
b) Ms. Elizabeth Ayuo at KEMRI-CDC, Kisumu: (e-mail)- firstname.lastname@example.org or email@example.com
I am very much in favour of reciprocal monitoring schemes, as proposed -if I am not wrong- by Roma Chilengi some times ago. This (a) would help to build capacity and learn from each other, (b) would contribute to rationalizing the use of (often limited) available human and finacial resources, and (c) would help maintaining a real link between the site and the monitor in-between two visits.
I would like to elaborate a bit on the last point: the monitor should, according to the GCP, be te main link between the site and the sponsor/coordinator of the research. If he/she belongs to an external organization,there is the concrete risk that he/she cannot play this role of "continuous link", which is essential for following up on monitoring's findings and for anticipating and preventing problems and difficultieds at the site.
A good option could be to train some staff in each research group in GCP-monitoring and involve them in such "reciprocal monitoring scheme", carried out according to standards pre-agreed among the concerned institutions. In my opinion, this role should be preferentially given to pharmacists, biologists or lab people, who could monitor both the clinical (GCP) and laboratory (GCLP) aspects of a clinical trials. Best wishes,