What is reciprocal monitoring?

Reciprocal monitoring is a pragmatic approach to clinical trial monitoring which borrows from the success of an in-house monitoring scheme adopted in a research institution in a developing country as an innovative approach to trial monitoring (1). It entails having a network of clinical trial sites from which a pool of potential monitors is created. The potential monitors then undergo monitoring training and certification and thereafter are allocated to monitor studies conducted in other sites while studies in their own sites are monitored by another team of monitors.

Examples of reciprocal schemes can be found in South East Asia and East Africa (www.EACCR.org).

Steps in reciprocal monitoring

i) A network of research sites

ii) Each site nominates one or two potential monitors

iii) The potential monitors undergo a theoretical and practical training. A training curriculum and trainers are required for this.

iv) A monitoring coordinator is selected from the pool of trained monitors. The monitoring coordinator is responsible for scheduling monitoring and training activities.

v) The monitoring coordinator allocates two or three monitors to clinical trials within the network. The monitors will need to develop a monitoring plan for the study they are allocated to which is reviewed by the monitoring coordinator.

vi) Developing monitoring documents. This is done by a select team of monitors representing the network sites. The documents developed e.g. monitoring plan, checklists, reporting forms are typically adopted from templates used in the different sites/institutions.

vii) The newly qualified monitors will need to be coupled with experienced monitors for the initial visits.

viii) A platform for sharing knowledge and monitoring experiences (the global health trials programme creates such a forum - www.GlobalHealthTrials.org) and an annual face to face meeting of the monitors.

ix) A review mechanism using pre developed evaluation tools. This is important to evaluate the usefulness and impact of this scheme which is then documented and shared with the wider scientific community.

Potential benefits

• Cheaper than CRO model (1-3)

• Cross breeding i.e. sharing of experiences between sites

• Collective improvement of quality in conducting trials across the sites

How do you evaluate the scheme?

Evaluation is a critical step in determining the impact and usefulness of a scheme. The schemes will share a comprehensive evaluation process through which we aim to establish the benefits, limitations and cost effectiveness of this approach to monitoring.

You can download numerous templates, SOPs and checklists for monitoring at our Templates Library

This article originally appears on the Global Health Trials resources. Please visit us for more resources relating to trials.

References

  1. Chilengi R, Ogetii G, Lang T. A Sensible Approach To Monitoring Trials: Finding Effective Solutions In-house. WebmedCentral CLINICAL TRIALS 2010;1(10):WMC00891

  2. Shuchman M. Commercializing clinical trials--risks and benefits of the CRO boom. The New England journal of medicine. 2007 Oct 4;357(14):1365-8.

  3. Wadman M. The quiet rise of the clinical contractor. Nature. 2006 May 4;441(7089):22-3.

Reply

  • DavelineNyakundi Daveline Nyakundi 26 Apr 2011


    Fantastic model!
    We are in the process of implementing this with the EACCR region. The benefits are enormous.
    Daveline

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