CQAP (CASRAI)Professional
Clinical Research Quality Assurance & Audit — Professional
- Nominal
- 115 h
- Domains
- 8
- Exam items
- 72
- Cut score
- 70%
$349USD
View credentialCQAA (CASRAI)
Clinical Research Quality Assurance & Audit Certification — Advanced
LevelAdvancedCQACQAA (CASRAI)
140 h
Nominal
Self-paced study
6
Lessons
6 modules
6
Domains
Exam blueprint
68
Exam items
Per attempt
70%
Pass mark
Fixed, uncurved
90
Retake wait
Days
What you earn
The credential itself
Pass the examination and CASRAI issues this certificate and the post-nominal CQAA (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 Quality Assurance & Audit — Advanced
and is admitted to the designationCQAA (CASRAI)
Verify atcasrai.org/verify/CASRAI-CQA-2026-SXK9PC
Certifications
CQAA (CASRAI) — Clinical Research Quality Assurance & Audit, Advanced
CASRAI·Issued Mar 2026·Credential ID CASRAI-CQA-2026-SXK9PC
casrai.org/verify/CASRAI-CQA-2026-SXK9PC
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.
| Domain | Proportion of exam | Weight | Items |
|---|---|---|---|
| Designing and governing a quality management system across an organisationA1 | 18%≈ 12 items | ≈ 12 | |
| The audit programme: strategy, resourcing, coverage and defensibilityA2 | 18%≈ 12 items | ≈ 12 | |
| Leading complex, for-cause and cross-border auditsA3 | 16%≈ 11 items | ≈ 11 | |
| CAPA systems, root-cause methodology and effectiveness at programme levelA4 | 16%≈ 11 items | ≈ 11 | |
| Computerised-system validation governance and data-integrity strategyA5 | 16%≈ 11 items | ≈ 11 | |
| Inspection management, regulatory relationships and remediationA6 | 16%≈ 11 items | ≈ 11 | |
| Total | 100% | 68 |
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
6 modules, 6 lessons
Every lesson and every learning outcome is listed. The lesson bodies open on enrolment; nothing else about the course is withheld.
6 modules · 6 lessons · 140 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
A-M1
1 lesson · 24 h
- Locked.Designing and governing a quality management system24 h · Locked
On completion you will be able to
- Design a quality management system for an organisation and defend its proportionality under Principle 7. Construct the governance structure — quality council, escalation routes, management review — and specify the metrics that drive it. Demonstrate how the system detects its own failure. Analyse the organisational position of the quality function and identify what compromises its independence.
Module 2
A-M2
1 lesson · 24 h
- Locked.Governing an audit programme24 h · Locked
On completion you will be able to
- Derive programme coverage from risk and defend it against a regulator who has found what the programme missed. Model resourcing. Design auditor qualification and development under §3.11.2.1. Evaluate the shared-audit and consortium models. Specify metrics that measure the programme's effectiveness rather than its output.
Module 3
A-M3
1 lesson · 22 h
- Locked.Leading complex, for-cause and cross-border audits22 h · Locked
On completion you will be able to
- Determine when a for-cause audit is the right instrument and scope it under uncertainty. Compose a team and decide when legal involvement is required. Preserve evidence. State precisely where audit stops and investigation begins. Plan a cross-border audit against data-protection, confidentiality and employment-law constraints.
Module 4
A-M4
1 lesson · 22 h
- Locked.CAPA systems at programme level22 h · Locked
On completion you will be able to
- Govern a CAPA system end to end. Set the analysis standard and enforce it. Design effectiveness checks at portfolio level. Diagnose a CAPA system from its trend data. Handle a root cause that implicates senior management.
Module 5
A-M5
1 lesson · 24 h
- Locked.Validation governance and data-integrity strategy24 h · Locked
On completion you will be able to
- Design a risk-classification scheme for a portfolio of systems and defend a decision to validate one lightly and another heavily. Specify a vendor-assessment approach and state why responsibility is non-transferable. Govern audit-trail review as a programme. Design a data-integrity control set rather than a statement of principles.
Module 6
A-M6
1 lesson · 24 h
- Locked.Inspection management and remediation24 h · Locked
On completion you will be able to
- Govern readiness as a state with an owner and a metric. Lead the hosting of an inspection across sites. Draft and defend a response letter as an organisational commitment. Design a remediation programme with governance, resourcing and a board reporting line. Manage a committed date that will be missed.
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 Clinical Research Quality Assurance & Audit
Levels are independent purchases. There is no prerequisite chain — sit whichever level matches the work you already do.
