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. |