Who should monitor subject recruitment/retention?

As described earlier, an activity that requires on-going attention in clinical trials is the recruitment and retention of participants in your study.  It is your responsibility as the PI to monitor patient recruitment and retention in the study.   NHLBI program staff will also monitor enrollment at least annually via your progress report.  Some studies will provide enrollment information more regularly but communication between NHLBI and the investigator about patient accrual is encouraged.  The policy on Terms and Conditions for Accrual of Research Subjects in Research offers further information on single-or multi-center studies that expect to recruit 150 or more subjects.  (See “Recruitment Strategies”)

The Office of Research on Women's Health provides an Outreach Notebook and Frequently Asked Questions on the topic of recruitment and retention of women and minorities as research subjects with practical applications for conducting NIH-funded research.