GCPF (CASRAI)

Good Clinical Practice Certification — Foundation

LevelFoundationGCPGCPF (CASRAI)

28 h

Nominal

Self-paced study

Lessons

7 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 GCPF (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

Good Clinical Practice — Foundation

and is admitted to the designationGCPF (CASRAI)

Verify atcasrai.org/verify/CASRAI-GCP-2026-24UM63

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

GCPF (CASRAI) — Good Clinical Practice, Foundation

CASRAI·Issued Mar 2026·Credential ID CASRAI-GCP-2026-24UM63

casrai.org/verify/CASRAI-GCP-2026-24UM63

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
Ethical lineage and the Principles of ICH GCPF1	20%≈ 8 items	≈ 8
Roles, responsibilities and oversightF2	18%≈ 7 items	≈ 7
Informed consentF3	16%≈ 6 items	≈ 6
Investigational product and participant safetyF4	15%≈ 6 items	≈ 6
Source data, records and essential recordsF5	18%≈ 7 items	≈ 7
The regulatory landscapeF6	13%≈ 5 items	≈ 5
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

7 modules, 7 lessons

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

7 modules · 7 lessons · 28 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 GCP is, and where it came from4 h · Locked
  On completion you will be able to
  - By the end of this module the learner can:
  - State the two purposes of GCP given in E6(R3) §I (protection of participants' rights, safety and well-being; reliability of results).
  - Explain the harmonisation objective — mutual acceptance of trial data across ICH regions — in one paragraph.
  - Sequence the Nuremberg Code, the Declaration of Helsinki and the Belmont Report, and state what each contributed.
  - Distinguish a guideline from a regulation and explain how ICH guidelines acquire legal force nationally.
  - State the E6 version history and identify E6(R3) as current.
Module 2
F-M2
1 lesson · 5 h
1. Locked.The 11 Principles5 h · Locked
  On completion you will be able to
  - Recite the subject of each of the 11 Principles.
  - Identify which Principle a described trial decision engages.
  - Apply Principle 1.1 to a conflict between scientific interest and participant welfare.
  - Explain Principle 10.1 in the specific case of a sponsor using a CRO.
Module 3
F-M3
1 lesson · 4 h
1. Locked.Who does what: roles, delegation and oversight4 h · Locked
  On completion you will be able to
  - Define sponsor, investigator, institution, IRB/IEC, monitor, auditor and service provider.
  - Given an activity, identify the accountable party.
  - Distinguish sponsor transfer from investigator delegation.
  - Read a delegation of authority log and identify two defects.
Module 4
F-M4
1 lesson · 5 h
1. Locked.Informed consent as a process5 h · Locked
  On completion you will be able to
  - Distinguish the consent process from the consent document.
  - List the information a potential participant must receive.
  - Identify when a legally acceptable representative is required and when assent applies.
  - Determine from a vignette whether re-consent is required.
  - Identify three defects in a described consent encounter.
Module 5
F-M5
1 lesson · 3 h
1. Locked.Investigational product, randomisation and blinding3 h · Locked
  On completion you will be able to
  - Trace investigational product accountability from receipt to destruction.
  - State what a temperature excursion requires of the site.
  - Explain why blinding is maintained through manufacturing, handling and labelling.
  - Distinguish an emergency unblinding from an unblinding for convenience.
Module 6
F-M6
1 lesson · 4 h
1. Locked.Safety: recognising, classifying and reporting4 h · Locked
  On completion you will be able to
  - Define adverse event, adverse reaction, serious adverse event, unexpected adverse reaction and SUSAR.
  - Classify events from vignettes.
  - State the investigator's reporting obligations and to whom.
  - Distinguish "serious" from "severe."
Module 7
F-M7
1 lesson · 3 h
1. Locked.Source data, records and essential records3 h · Locked
  On completion you will be able to
  - Identify the source record in a described data flow.
  - State the ALCOA+ attributes and apply them to a documentation defect.
  - Explain the E6(R3) essentiality test and contrast it with the R2 list.
  - Distinguish the TMF from the ISF.

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.

The ladder

Other levels of Good Clinical Practice

Levels are independent purchases. There is no prerequisite chain — sit whichever level matches the work you already do.

GCPP (CASRAI)Professional

Good Clinical Practice — Professional

Nominal: 84 h
Domains: 7
Exam items: 40
Cut score: 70%

$349USD

View credential

All CASRAI credentials

Common questions

About GCPF (CASRAI)

How long does GCP certification last?

A CASRAI GCP credential is issued for a three-year cycle, after which it is renewed through recertification. The issue and expiry dates are printed on the certificate and shown on its public verification page, so an employer can confirm currency at any time.

What is GCP certification?

Good Clinical Practice certification attests that the holder has been examined against the ICH E6 standard governing the design, conduct, recording and reporting of clinical trials. The CASRAI credential is assessed against a published blueprint and pass mark rather than awarded for course attendance.

Is good clinical practice certification worth it?

GCP knowledge is expected of anyone working on a clinical trial, and most free training issues a completion certificate rather than an assessed credential. A verifiable, examined credential with a published blueprint and a recertification cycle is what distinguishes the two on a CV.

What does GCP certification cost?

Pricing is shown on this page and covers the full syllabus, the examination and issuance of the verifiable credential.