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ICH- GCP defines monitoring as the act of overseeing the conduct of a clinical trial, that is, ensuring that the trial is conducted according to protocol, GCP, SOP and regulatory requirements. It is the responsibility of the sponsor to ensure the trial 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 trial. In general there is need for on-site monitoring, before, during and after the trial; 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 trial in accordance with GCP” .
Who can monitor:
The sponsor appoints a person with appropriate training and scientific and/or clinical knowledge to monitor a clinical trial.
Monitoring as a quality assurance activity
Monitoring is a quality control measure put in place to ensure the integrity of trial data and protection of the rights and well-being of study participants is protected. Unlike auditing, which is done by a person independent of the trial a monitor more or less functions as a member of the trial team and acts as a link between the study team and the sponsor. Monitoring is an ongoing process conducted before, during and after the trial and is classified in four distinct types of visits (pre-initiation, initiation, routine and close out).
Approach to monitoring
Typically the sponsor appointed monitor conducts monitoring regular visits to the site according to an agreed upon monitoring plan. Recent trends have seen this task being delegated to the contract research organisation and this is evidenced by the rapid growth in the number and portfolio of CROs [2,3].
Pragmatic approaches to trial monitoring have been suggested. One approach is central statistical monitoring of trial data to identify sites which are doing poorly and arranging site visits to review the site’s conduct of the trial . This approach is helpful in that the monitors are able to focus on areas/issues which require attention which they would not necessarily pick up during routine visits.
In an institution with several studies under its umbrella, in-house monitoring i.e. training trial staff to monitor trials they are not directly involved in has been hailed as novel way of achieving data quality without incurring the astronomical costs associated with trial monitoring (Chilengi et al). This approach was found to not only ensure quality but to also serve as a platform for mentoring of trial staff.
Visit our Templates Library for numerous downloadable SOPs, guidelines, checklists, and documents for monitoring which you can download and adapt for your trial.
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International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, Guideline for Good Clinical Practice E6(R1), Available at http://www.ich.org/LOB/media/MEDIA482.pdf, (1996).
Shuchman, M., Commercializing clinical trials--risks and benefits of the CRO boom. The New England journal of medicine 357 (14), 1365-1368 (2007).
Wadman, M., The quiet rise of the clinical contractor. Nature 441 (7089), 22-23 (2006).
Baigent, C., Harrell, F.E., Buyse, M., Emberson, J.R., & Altman, D.G., Ensuring trial validity by data quality assurance and diversification of monitoring methods. Clinical trials (London, England) 5 (1), 49-55 (2008).
Inhouse monitoring is simple and avoid high cost of trial. A trained personal not involved in that specific trial can very well monitor that trial.
I would love to start up with conversation again, particularly focussing on how institutions can develop cost effective monitoring systems and is there a place for cross country monitoring across institutions
While monitoring by the sponsor is a given, i agree that institutions conducting the clinical trials should have an inhouse person not directly involved with the trial to do on-going monitoring.
Consenting process in developing countries have to be reviewed very careful taking into consideration of rights of participants in clinical trials.Quality of data must focus the ethics,time and resources used in the clinical trials and future community development.
Developing quality standards and a quality culture in centers largely doing observational studies can be good preparation for clinical Trials. Currently monitoring services and audits are skewed towards clinical trials and hence the need to develop institutional mechanisms to ensure quality. Internal monitoring is one of the approaches we've adopted and the results have been remarkable!
We have limited capacity to conduct GCP compliant clinical trials in most countries in developing world. This cuts across human resource capacity, infrastructure, ethical review and high illiteracy level among potential trial participants making informed consent process a challenge. As part of site development initiatives by sponsors of clinical trials conducted in developing countries is to conduct epidemiological cohort studies "mock trials" at ethically recognized standards. This will provide sites opportunity to learn and apply basic GCP/GCLP principles in conduct of their activities before they conduct registration type of trials. This will instill clinical research quality culture and processes at clinical research sites under development for conducting future registration standard ICH GCP compliant clinical trials; monitoring and targeted audits at investigator sites are necessary at this point to provide ongoing support in terms of training and guidance.