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In-life monitoring.

With detailed protocols and SOPs it might be easy to overlook the importance of ‘in-life’ monitoring, the actual conduct of experimental phase of the study. In-life monitoring begins as early as when animals are assigned to the study or during an acclimation/training phase, but the most important part of this phase begins on the first day of dosing.

In-life monitoring on Day 1 of dosing is a real opportunity to ensure that there are no misunderstandings in the precise execution of the protocol, no mishandling of information and no problems with data collection, all of which could potentially negate the study. You then have the opportunity to make changes, and, if necessary, halt and then re-initiate the study without critical loss of time. While the need to actually halt the study will rarely occur with highly standardized tests, your preferences for study conduct may still be a little different from that of the CRO. Amendments or deviations at this stage are unlikely to jeopardize the successful outcome of the study.

With less frequently conducted or new studies, you can't always anticipate everything, especially practical logistics, when designing and detailing the protocol for a study. It may be only when you are on site observing the study conduct that you realize that additional modifications may be needed. For example, in one juvenile study, the subjects were not able to easily access the water bottles, and a change in cage size was requested. Though the problem translated to an initial but temporary weight loss, this was satisfactorily addressed and subsequently explained in the report. This problem could have been missed had the in-life monitoring not been conducted.

Areas to pay particular attention to:

  • Your end point. If results show extremes, you may want to stop the study and adjust
  • How tests are actually conducted. Pay particular attention to the small details, including animal handling, data collection and marking of key points of study, possible noise or other types of interference as a result of other activities or studies nearby, and issues with cages or laboratory set-up and equipment
  • The Study Notebook. You can only review this on site - which of course you can request to do anytime you visit. However, a review during the actual in-life activities is the best opportunity to ensure that the Study Notebook entries are acceptable and timely. There may be some additional notes that you want recorded
  • QA (Quality Assurance) Group monitoring. This is a great opportunity to observe auditing in action. Ask for them to audit the study on the day you plan to be there as this will offer a separate, objective point of control and you can be satisfied that there is good communication and careful control of your study by all groups involved.

The point is to make it a better study for everybody, ensure standardization in the conduct of the entire in-life phase, and foster good communication of expectations and understanding. It's not about finding fault or pointing fingers as much as it is an opportunity to establish good rapport and appreciate and resolve possible challenge areas. If necessary, the changes could make the study easier.

Dr. Caroline Bell
Founder and CEO



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