CRMF (CASRAI)

Clinical Research Monitoring Certification — Foundation

LevelFoundationCRMCRMF (CASRAI)

35 h

Nominal

Self-paced study

Lessons

8 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 CRMF (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 — Foundation

and is admitted to the designationCRMF (CASRAI)

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

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

CRMF (CASRAI) — Clinical Research Monitoring, Foundation

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

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

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 weights6 domains · 39 scored items
Domain	Weight	Items
What monitoring is, and where the obligation comes fromF1	16%≈ 6 items	≈ 6
The trial lifecycle from the monitor's seatF2	15%≈ 6 items	≈ 6
Consent verification and participant-protection checksF3	16%≈ 6 items	≈ 6
Source records, source data review and source data verificationF4	20%≈ 8 items	≈ 8
Investigational product, safety and deviationsF5	18%≈ 7 items	≈ 7
Reporting, escalation and the oversight chainF6	15%≈ 6 items	≈ 6
Total	100%	39

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

8 modules, 8 lessons

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

8 modules · 8 lessons · 35 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
F-M1
1 lesson · 4 h
1. Locked.What monitoring is for4 h · Locked
  On completion you will be able to
  - By the end of this module the learner can:
  - State the purpose of monitoring in one paragraph using the §3.11.4 aim and the Glossary definition, without reciting a list of visit types.
  - Classify a described activity as monitoring, quality control, quality assurance, audit or inspection, and justify the classification from the E6(R3) Glossary.
  - Explain why E6(R3) places monitoring under Quality Control and what follows from that placement.
  - Identify who may and may not perform a monitoring activity at a given site.
Module 2
F-M2
1 lesson · 4 h
1. Locked.Where the obligation comes from4 h · Locked
  On completion you will be able to
  - Distinguish a guideline from a regulation and state how ICH GCP acquires legal force in a given jurisdiction.
  - Cite the US, EU and UK sources of the monitoring obligation.
  - Determine, for a described trial, which national framework's monitoring requirements apply.
Module 3
F-M3
1 lesson · 4 h
1. Locked.The life cycle and the monitoring plan4 h · Locked
  On completion you will be able to
  - Describe the §3.11.4.5 activity set across the trial life cycle.
  - Explain what a monitoring plan is, what §3.11.4.3 requires it to contain, and how it constrains the monitor.
  - Name the industry visit convention and state that ICH does not prescribe it.
Module 4
F-M4
1 lesson · 5 h
1. Locked.Consent verification5 h · Locked
  On completion you will be able to
  - Verify from a document set that consent was obtained before participation.
  - Identify the five most common consent defects and classify each as remediable or not.
  - Apply the monitor's confidentiality obligations when handling identifiable source records.
Module 5
F-M5
1 lesson · 6 h
1. Locked.Source records, SDR and SDV6 h · Locked
  On completion you will be able to
  - Identify the source record for each data point in a described data flow.
  - Distinguish source data review from source data verification and state that neither is an ICH-defined term.
  - Explain, citing §3.11.4.5.4(b), why verification is performed on samples.
  - Apply the E6(R3) data-integrity attributes and distinguish them from ALCOA+.
Module 6
F-M6
1 lesson · 5 h
1. Locked.Investigational product and safety5 h · Locked
  On completion you will be able to
  - Perform an IP accountability check against §3.11.4.5.3(a)(i)–(vii).
  - Classify an event as AE, SAE or SUSAR using the E6(R3) Glossary criteria.
  - Identify an adverse event present in a source record and absent from the reported data.
Module 7
F-M7
1 lesson · 4 h
1. Locked.Deviations, findings and reports4 h · Locked
  On completion you will be able to
  - Identify a protocol deviation and determine whether the sponsor's §3.9.3 criteria make it important.
  - Draft the significant-findings section of a monitoring report to §3.11.4.6(a).
  - Distinguish an observation, a finding and an action.
Module 8
F-M8
1 lesson · 3 h
1. Locked.The oversight chain, and what a monitor does not do3 h · Locked
  On completion you will be able to
  - State who is accountable when monitoring has been transferred to a CRO.
  - Route a finding through the correct escalation path.
  - Identify the point at which a monitoring matter stops being one.

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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