NIDCR’s Accrual and Retention (A&R) Monitoring Principles and Guidance

As part of NIDCR’s responsibility to ensure the ethical conduct of human subjects research and proper stewardship of public funds, the Institute has implemented standardized and routine Accrual and Retention (A&R) Monitoring. Accrual and Retention Monitoring (A&R) ensures regular monitoring of a clinical study’s human subjects accrual and retention progress against pre-determined study goals and benchmarks to allow ongoing assessment of study feasibility.

For extramural studies, NIDCR’s clinical research subject to NIDCR Clinical Terms of Award (CToA) are subject to NIDCR’s A&R Monitoring expectations.

For intramural studies, the Office of the Clinical Director (OCD) will determine if the clinical study is subject to NIDCR’s A&R Monitoring expectations.

A&R Monitoring Components A&R Monitoring Framework Accrual and Retention Monitoring through the NIDCR Clinical Research Management System (NIDCR-CRMS)

The NIDCR Clinical Research Management System provides NIDCR staff and study teams the ability to electronically submit, review, and manage accrual and retention monitoring plans and reports [Study Accrual and Retention Plan (SARP), Accrual and Retention (A&R) reports, and Challenges forms].

Principal Investigators (PIs) designated as the point-of-contact of studies that are subject to NIDCR’s accrual and retention monitoring expectations will receive an automated email from the NIDCR-CRMS with instructions on how to access the system and submit the initial SARP. PIs may choose to designate one or more study team members (e.g., Research Nurse, Study Coordinator, Co-Investigator) to access the study’s accrual and retention page and submit reports on behalf of the study team.