Karen Estelle Woodin, Ph.D., known in the clinical trials industry as a long-time industry consultant and author, passed away last week after a short bout with malignant endometrial cancer. She was 74.

Karen was part of the CenterWatch family as author of its popular The CRA’s Guide to Monitoring Clinical Research, co-authored with John C. Schneider, and The CRC’s Guide to Coordinating Clinical Research, both of which are considered essential guides in the field.

A graduate of Western Michigan University with both bachelor of science and master of science degrees in statistics, Karen received her doctorate in epidemiology from the University of Massachusetts School of Public Health.

She then spent more than 20 years at The Upjohn Company, primarily in biostatistics and clinical trial operations. After retiring from the drug company in 1999, she began consulting in clinical trials operations, good clinical practices and standard operating procedures. Working with investigative sites, sponsors and IRBs, she also, until recently, developed and taught courses in those areas.

Karen was active in the Drug Information Association (DIA). As a long-time member, she served on the board of directors and as chair of the steering committee for the Americas. She also developed courses for DIA and was a recipient of the DIA Outstanding Service Award.

Beyond her professional work, she was involved in many other causes. She also was a mentor to numerous people throughout her life, leading to her motto, “Nice Matters.”

Her varied interests included needlecraft, cooking, crafts, playing piano, gardening and reading. Together with her husband, John Albert Kapenga, whom she met in graduate school, they enjoyed taking cooking classes together and entering cooking competitions.

In addition to her husband, she leaves a son, Joseph Edward Woodin, two grandsons, four sisters and other extended family including nieces and nephews.

For an appreciation of Karen Woodin, please see next Monday’s CWWeekly.