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

Prior to Study Activation

Prior to the initiation of human subjects research, the study team must complete a Study Accrual and Retention Plan (SARP) that outlines planned study dates and goals for accrual and retention. Study teams will receive an email notification from the NIDCR Clinical Research Management System (NIDCR-CRMS) with instructions for submission requesting initial completion of the SARP within 30 days of the request.

During Study Conduct

During the course of a study, the study team and the NIDCR Program Official (PO)/OCD (Office of the Clinical Director) may mutually agree that changes to the SARP are warranted. In this scenario, the NIDCR PO/OCD will initiate a request for the study team to amend the SARP through the NIDCR-CRMS. The NIDCR PO/OCD may request additional changes and/or clarifications following receipt and review of the amended SARP.

Following the initiation of human subjects research, study teams will submit Accrual and Retention (A&R) reports through the NIDCR-CRMS at specified time frames for review by NIDCR throughout the course of the study. A&R reports will include information regarding study and site accrual and retention numbers, as well as actual completion dates of study events (e.g., date of first participant enrolled, date of database lock) against planned dates and timelines established as part of the SARP.

If actual study timelines or accrual and/or retention numbers fall behind planned goals or timelines, the NIDCR Program Official (for extramural studies) or the Office of the Clinical Director (for intramural studies) may request study teams complete Challenges page(s) to document any identified challenges, provide new strategies for improvement to study accrual and/or retention, and obtain additional information from study teams. The study team and NIDCR may mutually agree that an amendment to the study SARP is necessary.

NIDCR may take official actions based on continued deficiencies, including study suspension or termination.

A&R Monitoring Framework

A study is considered to be in the start-up/planning period until the enrollment of the first study participant. The study’s Planning Period End Date is a fixed field that is set by NIDCR and reflected in the SARP. This date is carried into the A&R Report forms for study team reference.

The NIDCR-CRMS will automatically calculate the study’s start-up/planning period zone into one of the three zones – green, yellow, or red:

Green Zone: First participant is enrolled prior to the Planning Period End Date

Yellow Zone: First participant enrolled up to 6 months past the Planning Period End Date

Red Zone: First participant enrolled more than 6 months past the Planning Period End Date

The NIDCR-CRMS will automatically calculate actual accrual progress reported through A&R reports against planned accrual into one of three zones – green, yellow, or red:

Green Zone: Actual accrual is 100% to 80% of the planned benchmark

Yellow Zone: Actual accrual is <80% to 60% of the planned benchmark

Red Zone: Actual accrual is less than 60% of the planned benchmark

Study teams will enter the planned study attrition rate (sometimes referred to as the ‘early discontinuation’ or ‘drop-out’ rate) into the SARP, as described in the study protocol.

The NIDCR-CRMS will automatically calculate actual attrition reported through A&R reports against planned attrition into one of three zones – green, yellow, or red:

Green Zone: Actual attrition rate is less than or equal to planned attrition rate

Yellow Zone: Actual attrition rate is planned attrition rate + up to 5%

Red Zone: Actual attrition rate is planned attrition + 5% or more

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.

Troubleshooting

For study teams who have access to the NIDCR-CRMS or have received an invitation to create an account, and are experiencing technical difficulties, please contact user support at: askNIDCR@rhoworld.com.