Turnover of personnel

By |May 29th, 2019|Categories: Monitoring|

The recently issued draft guidance on A Risk Based Approach to Monitoring of Clinical Investigations recommends that turnover at the clinical investigator site or among monitoring staff be one factor you consider when determining the timing, types, frequency and extent of monitoring activities. Turnover at the site Historically a change in personnel at the investigative site warranted an onsite visit by the CRA to ensure that the new research coordinator was trained on the protocol and had been added to the Delegation of Authority log. Depending on the resources at the site, a new coordinator may be able to shadow the RC who is leaving the project. Perhaps they may have been the back-up coordinator and are now taking over primary responsibility for the study. Each situation is unique and should be evaluated accordingly. Setting aside a pool of visits to cover such eventualities makes sense. An on-site visit [...]

One reason why clinical trials fail to recruit and retain subjects – Poor Communication

By |February 12th, 2019|Categories: Communication, Recruitment|

Communication or lack thereof, miscommunication and poor communication. It is considered a soft skill but in clinical trials it is a critical skill. I have identified 5 stages in the clinical development cycle where communication is of critical importance. 1. Protocol development Don’t wait until your protocol is finalized before seeking input from key stakeholders such as an investigator ‘on the ground’ (not just the KOL in an academic institution), a research coordinator and a patient representative. You may not like their feedback and some of the procedures may be non-negotiable but listen to them. Isn’t better to modify the protocol now before it is finalized rather than having to do an amendment in 6 months’ time? 2. The start-up process This is when the CRO acting for the Sponsor can make a good impression. Provide clear, detailed instructions on what [...]

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