CRMP (CASRAI)

Clinical Research Monitoring Certification — Professional

LevelProfessionalCRMCRMP (CASRAI)

90 h

Nominal

Self-paced study

Lessons

12 modules

Domains

Exam blueprint

Exam items

Per attempt

70%

Pass mark

Fixed, uncurved

Retake wait

Days

What you earn

The credential itself

Pass the examination and CASRAI issues this certificate and the post-nominal CRMP (CASRAI), signed by the Programme Director and verifiable by anyone, permanently, from the code on its face.

CASRAI Certification

Certificate of Professional Competence

This is to certify that

Dr. Amelia R. Hartley

has completed the prescribed programme of study and passed the examination in

Clinical Research Monitoring — Professional

and is admitted to the designationCRMP (CASRAI)

Verify atcasrai.org/verify/CASRAI-CRM-2026-XQMTV0

Specimen. Issued as a signed PDF and as a machine-readable Open Badge; the holder and code shown are illustrative.

How it appears on your CV

Certifications

CRMP (CASRAI) — Clinical Research Monitoring, Professional

CASRAI·Issued Mar 2026·Credential ID CASRAI-CRM-2026-XQMTV0

casrai.org/verify/CASRAI-CRM-2026-XQMTV0

Every certificate is issued under the signature of Dr. Diana Nieves Castro, MD, Programme Director of CASRAI Certification, who sets the syllabus, blueprint and pass mark for this credential.

It certifies that its holder passed the CASRAI examination for this course on the date shown, scored against the blueprint and pass mark published on this page — and anyone can confirm it from the verification code, without an account and without contacting us.

About this credential

What it covers

Body of knowledge

Exam blueprint

The exam is assembled to these weights on every attempt. They are published before purchase because a blueprint you cannot see is not a blueprint.

Domains and weights9 domains · 45 scored items
Domain	Weight	Items
The monitoring obligation, quality management, and the R2→R3 transitionP1	12%≈ 5 items	≈ 5
Risk-based monitoring design: strategy, plan and quality tolerance limitsP2	14%≈ 6 items	≈ 6
Centralised, remote and on-site monitoringP3	12%≈ 5 items	≈ 5
Site selection, qualification and initiationP4	10%≈ 5 items	≈ 5
Interim monitoring: consent, eligibility, source review and verificationP5	16%≈ 7 items	≈ 7
Investigational product, safety reconciliation and deviation managementP6	12%≈ 5 items	≈ 5
Essential records, the TMF and the ISF as the monitor encounters themP7	8%≈ 4 items	≈ 4
Monitoring reports, follow-up, escalation and for-cause monitoringP8	10%≈ 5 items	≈ 5
Sponsor–service provider oversight and the national frameworks comparedP9	6%≈ 3 items	≈ 3
Total	100%	45

Item counts are approximate. Each attempt draws a fresh form to the weights above, so the exact number of items per domain varies between attempts.

Syllabus

12 modules, 12 lessons

Every lesson and every learning outcome is listed. The lesson bodies open on enrolment; nothing else about the course is withheld.

12 modules · 12 lessons · 90 h

Lesson material opens once you are enrolled. The full syllabus and every learning outcome are shown here so you can judge the coverage before you pay.

Module 1
P-M1
1 lesson
1. Locked.Quality management, risk management and the R2Locked
  On completion you will be able to
  - Locate monitoring within §3.10 Quality Management and §3.11 Quality Assurance and Quality Control, and explain the consequences of that placement for who performs it and how it is planned.
  - Work the §3.10.1 risk cycle end to end for a supplied protocol.
  - Brief a study team on the R2→R3 changes that alter monitoring practice.
Module 2
P-M2
1 lesson · 10 h
1. Locked.Designing a risk-based monitoring strategy10 h · Locked
  On completion you will be able to
  - Derive a monitoring strategy from identified risks and justify the extent and nature of monitoring against §3.11.4's named factors.
  - Draft the strategy, methods and rationale sections of a monitoring plan to §3.11.4.3.
  - Specify a verification sampling approach and defend it by reference to §3.11.4.5.4(b).
  - Apply Article 48 of Regulation (EU) No 536/2014 to an EU trial and identify where it diverges from ICH.
Module 3
P-M3
1 lesson · 8 h
1. Locked.Centralised and remote monitoring8 h · Locked
  On completion you will be able to
  - Allocate monitoring activities across centralised, remote and on-site modalities and justify the allocation.
  - Interpret a centralised-monitoring signal and decide whether it triggers targeted site monitoring.
  - Specify the controls required for remote read-only source access.
Module 4
P-M4
1 lesson · 6 h
1. Locked.Monitoring in decentralised settings6 h · Locked
  On completion you will be able to
  - Define decentralised elements using Annex 2 and identify them in a supplied protocol.
  - Determine who is accountable for oversight of a home-nursing or DHT service provider, and evidence the determination.
  - Adapt a monitoring plan for a trial with decentralised elements.
Module 5
P-M5
1 lesson · 8 h
1. Locked.Site selection, qualification and initiation8 h · Locked
  On completion you will be able to
  - Assess a candidate site against §3.7 and §2.2 and produce a recommendation with evidence.
  - Verify resource adequacy rather than accept its assertion.
  - Confirm, in the §3.11.4.5.2(b) sense, that a site is ready to enrol.
  - Identify the agreement provisions monitoring depends on.
Module 6
P-M6
1 lesson · 12 h
1. Locked.Interim monitoring: eligibility, consent and source review12 h · Locked
  On completion you will be able to
  - Plan an interim monitoring activity from the monitoring plan's risk priorities rather than a generic checklist.
  - Verify eligibility criterion by criterion from source.
  - Detect unreported events, medications and deviations from source records.
  - Diagnose a consent defect and determine what is and is not remediable.
  - Adjust a sample when the first tranche shows a problem, and document the adjustment.
Module 7
P-M7
1 lesson · 8 h
1. Locked.Investigational product and safety reconciliation8 h · Locked
  On completion you will be able to
  - Reconcile an IP accountability record and locate the break.
  - Run a safety reconciliation between clinical and safety data and adjudicate the differences.
  - Determine expectedness against the Reference Safety Information and state the consequence of an out-of-date Investigator's Brochure.
Module 8
P-M8
1 lesson · 8 h
1. Locked.Deviations, noncompliance and CAPA input8 h · Locked
  On completion you will be able to
  - Classify a deviation against the sponsor's §3.9.3 criteria.
  - Distinguish deviation, noncompliance and serious noncompliance and route each correctly.
  - Supply monitoring evidence to a root-cause analysis without performing the investigation.
  - Recognise sponsor-caused noncompliance under §3.12.1.
Module 9
P-M9
1 lesson · 6 h
1. Locked.Essential records, TMF and ISF6 h · Locked
  On completion you will be able to
  - Apply the Appendix C.3.1 essentiality test to a record on no list.
  - Assess whether a site's records satisfy C.2.6.
  - Determine retention obligations in a named jurisdiction.
Module 10
P-M10
1 lesson · 8 h
1. Locked.Reports, escalation and triggered monitoring8 h · Locked
  On completion you will be able to
  - Write a monitoring report satisfying every element of §3.11.4.6(a).
  - Write a follow-up letter that produces closure evidence.
  - Escalate a finding by the correct route and with the correct urgency.
  - Plan a triggered monitoring activity and identify the point at which it should instead be an audit.
Module 11
P-M11
1 lesson · 8 h
1. Locked.Sponsor oversight of service providers8 h · Locked
  On completion you will be able to
  - Write the oversight section of a monitoring plan for a CRO-delivered trial.
  - Design an oversight activity that is not a second monitoring visit.
  - Determine which party is accountable for a given transferred activity.
Module 12
P-M12
1 lesson · 8 h
1. Locked.The national frameworks compared8 h · Locked
  On completion you will be able to
  - Route a serious breach correctly in the EU and the UK, with the correct deadline.
  - Distinguish a serious breach from serious noncompliance and from an important protocol deviation.
  - Describe the inspection framework the trial is exposed to in each named jurisdiction.
  - Identify where a national requirement has no ICH equivalent.

Assessment

How the exam works

The exam is closed-book and multiple choice. Each attempt draws a fresh form to the domain weights above, so no two attempts are the same paper and no answer key circulates. The pass mark is 70% and is fixed — there is no curve, no quota and no adjustment by cohort.

Scoring is immediate. You are shown your overall result and, for every item, the option you chose, the correct option and the reasoning behind it — whether you passed or not. A failed attempt may be retaken after 90 days. The wait exists so a retake is a second attempt at the material rather than a second attempt at remembering the paper.

Forms are assembled to the blueprint above or not at all: where a domain cannot yet be sampled to that standard, the exam declines to start rather than issue an unbalanced paper. Your material and progress are never affected, and there is no time limit on when you sit.

Passing candidates are issued a certificate with a verification code. Anyone can check that code on our public verification page without an account and without contacting us.

Certifying authority

Signed by Dr. Diana Nieves Castro, MD

CASRAI’s certification programme is academically and medically directed by Dr. Diana Nieves Castro, MD, Programme Director, who sets the syllabus and blueprint for this credential and signs every certificate issued under it.

CASRAI has maintained the terminology and reporting standards of research administration for over a decade. It assumed leadership of the CRediT contributor-roles taxonomy in 2014 and carried it through to adoption as ANSI/NISO Z39.104-2022, now in use by publishers, funders and institutions worldwide. This examination is drawn from that body of work.

What the credential certifies: that its holder passed the CASRAI examination for this course on the date shown, scored against the blueprint and pass mark published above — verifiable by anyone, permanently, from the code on its face.

Before you buy

The syllabus, learning outcomes, exam blueprint, pass mark and retake policy on this page are the complete specification of this credential. Everything that determines whether you pass is published here before you pay.

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