GCPP (CASRAI)

Good Clinical Practice Certification

LevelProfessionalGCPGCPP (CASRAI)

84 h

Nominal

Self-paced study

Lessons

11 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 GCPP (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 — Professional

and is admitted to the designationGCPP (CASRAI)

Verify atcasrai.org/verify/CASRAI-GCP-2026-HEYLTT

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

GCPP (CASRAI) — Good Clinical Practice, Professional

CASRAI·Issued Mar 2026·Credential ID CASRAI-GCP-2026-HEYLTT

casrai.org/verify/CASRAI-GCP-2026-HEYLTT

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 weights7 domains · 40 scored items
Domain	Weight	Items
GCP foundations, ethical lineage and the PrinciplesP1	12%≈ 5 items	≈ 5
Governance and oversight: IRB/IEC and regulatory authoritiesP2	12%≈ 5 items	≈ 5
Investigator responsibilitiesP3	18%≈ 7 items	≈ 7
Sponsor responsibilities, quality management and oversightP4	18%≈ 7 items	≈ 7
Data governance, source data, ALCOA+ and computerised systemsP5	16%≈ 6 items	≈ 6
Essential records, the TMF, the protocol and the Investigator's BrochureP6	12%≈ 5 items	≈ 5
Safety, noncompliance, and the national frameworks comparedP7	12%≈ 5 items	≈ 5
Total	100%	40

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

11 modules, 11 lessons

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

11 modules · 11 lessons · 84 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-M2
1 lesson · 6 h
1. Locked.Ethics in application: Helsinki, Belmont, vulnerability6 h · Locked
Module 2
P-M3
1 lesson · 7 h
1. Locked.IRB/IEC governance and regulatory interaction7 h · Locked
Module 3
P-M4
1 lesson · 9 h
1. Locked.Investigator responsibilities in depth9 h · Locked
Module 4
P-M5
1 lesson · 9 h
1. Locked.Sponsor quality management and risk-based approaches9 h · Locked
Module 5
P-M6
1 lesson · 7 h
1. Locked.Sponsor obligations: design, agreements, selection, financing7 h · Locked
Module 6
P-M7
1 lesson · 8 h
1. Locked.Data governance and the data life cycle8 h · Locked
Module 7
P-M8
1 lesson · 7 h
1. Locked.Computerised systems in trials7 h · Locked
Module 8
P-M9
1 lesson · 7 h
1. Locked.Essential records, the TMF and the ISF7 h · Locked
Module 9
P-M10
1 lesson · 6 h
1. Locked.The protocol, amendments and the Investigator’s Brochure6 h · Locked
Module 10
P-M11
1 lesson · 8 h
1. Locked.Safety assessment, reporting and noncompliance8 h · Locked
Module 11
P-M12
1 lesson · 10 h
1. Locked.The national frameworks compared, and Annex 210 h · Locked

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.

GCPF (CASRAI)Foundation

Good Clinical Practice — Foundation

Nominal: 28 h
Domains: 6
Exam items: 39
Cut score: 70%

$149USD

View credential

All CASRAI credentials

Common questions

About GCPP (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.