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INTRODUCTION

The need to establish a research administrative infrastructure often becomes apparent right about the time an investigator is finishing up their first trial. Because acquiring personnel, workspace, and a working knowledge of the institution’s contracting and finance processes happens relatively quickly when an investigator is starting up a study, investigators may not immediately recognize the need for setting up the infrastructure to support continued work. As daily operations roll along, investigators may assume that the financial books will balance, research staff and reports will need minimal administrative management, and viable study opportunities will continue to come along. Inevitably, milestone events occur—speed bumps such as the end of a trial, annual budget reconciliation, or employee turnover. This is where a proactive approach to handling research reports, tracking activities, and creating electronic or paper files for holding onto details will help the busy research professional manage timelines, details, and professional relationships.

TAKING CONTROL: DON’T LET INFORMATION MANAGE YOU

Investigators are responsible for the administrative oversight of their studies and may require administrative support to manage the daily operations of reporting, accounting, and human resources. Investigators must manage many research-related administrative details about personnel, sponsors, the number of studies, and revenue and expense data. The first step for organizing all of these details is to take control and then leverage this information for strategic planning and ongoing monitoring of the research enterprise’s status.

Taking control of the avalanche of details outside of, but critical to, conducting the research protocol is a necessary fact of life for research professionals. So how do you filter the relevant from the irrelevant details and critically select the most important information to manage? Why is the filter and selection process so critical? Because selecting, tracking, and storing information must have a purpose or it will take on a life of its own, consuming time and serving no one. Set your filter by forecasting how the daily information might be useful. Some information may be useful for leveraging solutions to problems. Historical information can be critically important for measuring progress or to avoid repeating mistakes. Then select the best indicators to base metrics on.

If you are not sure which metrics will be important, start with some fundamentals and incorporate “lessons learned” as you go. Sometimes a year or more can go by before data are needed for a report or to justify a change. For example, tracking the studies that the investigator is working on is important. But what about the opportunities that come along and are not pursued? Could the number and type of studies or the names of study sponsors be needed for a report? If the studies were turned down due to insufficient investigator or staff time, would knowing how many potential studies there were in the previous 12 months help justify hiring or collaboration? At that point the investigator may decide ...

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