A QA Perspective on Working with New Clinical Research Sites
Posted by Lorrie Divers, April 12, 2010, 2:34 AM
How difficult is it to train and set up investigator sites that have never been involved in clinical research
 
This question was posed to myself and other members of the Clinical Research Professionals group on LinkedIn. Thorough Good Clinical Practices (GCP) training, careful consideration of the site's capabilities, personnel resources, and commitment from the principal investigator (PI) are all important. However, in my opinion there are several other factors also critically important for a successful naive clinical research site.  
 
1) Practical training in managing the routine and non-routine tasks of conducting a clinical trial.
Much the process can be described in SOPs, however, for staff who has never conducted a clinical trial before, many of the things experienced personnel take for granted will be new and unknown. For example, they need to understand not only the importance of using the current, IRB-approved version of the informed consent form, but how to actually control the document to ensure that is done consistently and easily. They need to understand how to keep accurate investigational drug accountability records with periodical review the inventory, compare them to the accountability record and identify and investigate/correct any discrepancies in “real time” rather than 14 months later.

2) A site-specific monitoring plan and an experienced monitor who will be given adequate time to support the site, both remotely and with frequent monitoring visits.
Such plans should include visits focused on GCP compliance, not just source data verification and case report forms; they should help control enrollment and not allow a naive site to enroll a large amount subjects right at the very start without visiting very early (even just after the first subject) to monitor and assess how well the site has adhered to eligibility, consent, enrollment and protocol requirements; and plans should outline frequent contact among the monitor and study site between monitoring visits to answer questions and provide suggestions, encouragement and support.
 
There must be a substantial time and resource commitment on the part of the sponsor/CRO to really support and continually train the naive study site staff and PI, not just train them at the initiation visit or investigator meeting.

3) A dedicated clinical research coordinator (CRC)
By "dedicated" I mean not only a person who is interested and willing, but one who is specifically tasked with being the study coordinator, is given adequate time and support to do so (not just adding 4 more hours of work to an already 8 hour work day). They need to be able to work effectively with the PI and with whom the PI will work effectively and support, and of course, who is trained and supported by the monitor as described above. In my experience, the lack of a dedicated (in both senses of the word) CRC is one of the most significant failures for both research naive and research experienced study sites.

Central labs and CROs have to be willing to help new investigators and new study sites become involved in clinical research in order to meet the demands of the drug and device development business and the ever increasing pressures of rapid recruitment and study completion time lines. But we also have to be willing to provide them with the training, support, and monitoring to allow them to be successful. If a new PI has a bad experience - for example, a very negative sponsor audit or an FDA inspection - they are not likely to ever be a PI again.
 
What is your list of success factors when working with new investigator sites?
Category: Quality Assurance
Comments
Clinical Research Courses  8/16/2010 06:23:15 AM
What a tremendous article written on Clinical Research site training. It was a really interesting read. I would like to read more such articles. Thanks for sharing! http://www.clinimis.info/
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