The processes and steps included in trial planning and development are imperative to ensure a successful trial. One of the processes that are critical in ensuring a smooth and successful outcome, is investigator selection and site feasibility.
Site feasibility is the process of evaluating the possibility of conducting a clinical trial or study, at a particular site. The process aims at ensuring that the proposed clinical site can conduct the trial, within the budget and the timeline, whilst maintaining data integrity and participant safety. This step also includes the process of selecting an investigator for the site (site investigator). The monitoring team conducting the feasibility, also ensures that the trial can be conducted at the proposed site from an ethical and regulatory perspective.
Investigator identification and selection
For multicentre clinical trials and studies, having a well-trained, experienced and qualified investigator is essential, to ensure that the trial runs smoothly. Some of the factors that influence an investigator selection are:
- Education, training and experience
- Previous work in similar trials
- Conflicting commitments (other trials or studies) that impact on the investigator’s availability for the duration of the trial
- Investigator’s site team and infrastructure
- Any other protocol-specific requirements, imperative for the trial
References and further reading
- Rajadhyaksha, V. (2010), Conducting feasibilities in clinical trials: an investment to ensure a good study, Perspectives in Clinical Research, available online (last accessed on 26.02.2019).
- Good Clinical Practices for Clinical Research in India, Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, 2001, available online (last accessed on 26.02.2019).
- ICH Harmonised Guideline, Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2), current step 4 version, dated 9th November 2016, available online (last accessed on 26.02.2019).
The next sub-sections of the routemap provide information on some of the steps that need to be implemented in a site: