Site operations

Monitoring visits and remote monitoring: making them faster and smoother

By TrialNotice · Updated
Site director in a white coat showing a visiting monitor the study drug refrigerator during a site tour
Short answerMonitoring now blends on site visits, remote review of site records, and centralized analysis of data across all sites, under the risk based approach FDA endorsed in 2013 guidance and expanded in a 2023 Q&A. For sites, that means fewer routine visits but more continuous scrutiny of data. Visits go faster when source documents are current, queries are cleared beforehand, and issues are raised early.

How has monitoring changed?

FDA's 2013 final guidance described risk based monitoring and recommended centralized techniques, remote evaluation away from the sites, where possible to supplement or reduce on site monitoring, with a monitoring plan tailored to each trial's risks (Whitehall Training). FDA's 2023 Q&A says documented monitoring should include on site and remote monitoring of sites and centralized monitoring across sites, and FDA may request the sponsor's risk assessment and monitoring plan during an inspection (DiMe Society, citing FDA).

What is the difference between the types?

TypeWhat it is
On site monitoringA monitor visits the site to review records and conduct
Remote monitoringThe same site level review done off site (CASRAI)
Centralized monitoringAggregate analysis of data patterns across all sites (CASRAI)

What does this mean for sites?

  • Data entry timeliness and patterns are visible continuously, not just at visits.
  • Sites with unusual data patterns get more attention; clean sites get fewer visits.
  • Remote access to records requires secure systems and clear procedures.

How do you make visits efficient?

  1. Enter data within the sponsor's window and clear queries weekly.
  2. Prepare a visit packet: subject list, open issues, deviations, and product accountability.
  3. Give the monitor a workspace and timely access to staff.
  4. Agree on follow up items before the monitor leaves.

What about frequent monitor changes?

CRO turnover has run above 25% (ACRP, citing BDO), so new monitors arrive often. Keep an orientation sheet ready, and price monitor changes into your budget; one published schedule charges $500 per change (LSU Health). See building a relationship with your CRA.

What does a monitor notice first?

Enrollment. A clean site that is not enrolling still worries a sponsor. Monitors carry back the story of a site that has a credible patient pipeline, including referral relationships it can describe and measure.

Get your study in front of the right local physicians

TrialNotice builds a physician referral pipeline around one active study. We identify relevant local physicians within driving distance of your site, send study aligned direct mail, follow up by email and LinkedIn, track engagement with recipient level QR codes, and route warm responses into your site team's workflow.

Talk to TrialNotice

Sources

  1. Whitehall Training, summary of FDA's 2013 final guidance on risk based monitoring
  2. DiMe Society Navigator, excerpts from FDA's "A Risk Based Approach to Monitoring of Clinical Investigations: Questions and Answers" (Final, 2023)
  3. CASRAI, "On Site vs Remote vs Centralized vs Risk Based Monitoring"
  4. ACRP, "State of the Clinical Research Workforce" report (2020)
  5. LSU Health New Orleans Clinical Trials Office, Budget Development training

Keep reading

Three clinical research coordinators laughing over coffee at a table in a sunny staff break room
Site operations

Why research coordinators leave, and how sites keep them

Site turnover runs 35% to 61% a year, and 85% of departing staff go to sponsors and CROs. Here is why coordinators leave, what turnover costs a site, and what keeps them.

 Tired coordinator in navy scrubs rubbing her eyes at a desk with two monitors and a stack of binders
Site operations

Sponsor training burden: where coordinator hours really go

Sites average 17.5 hours per study per month on training, and 65% of mandatory training is considered redundant. Here is the data, the industry efforts to cut it, and what sites can do now.

 Coordinator moving a sticky note on a crowded study calendar board in a research office
Site operations

Why study startup takes so long, and where sites lose weeks

Study startup averages 31.4 weeks from site identification, and the contract and budget stages take the largest share. Here is where the time goes and which delays a site controls.