CLIF (CASRAI)

Clinical Data Management Certification — Foundation

LevelFoundationCLICLIF (CASRAI)

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 CLIF (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 Data Management — Foundation

and is admitted to the designationCLIF (CASRAI)

Verify atcasrai.org/verify/CASRAI-CLI-2026-IKWAZ7

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

CLIF (CASRAI) — Clinical Data Management, Foundation

CASRAI·Issued Mar 2026·Credential ID CASRAI-CLI-2026-IKWAZ7

casrai.org/verify/CASRAI-CLI-2026-IKWAZ7

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 · 39 scored items
Domain	Weight	Items
Data management planning and study start-upF1	18%≈ 7 items	≈ 7
Data collection design and collection standardsF2	18%≈ 7 items	≈ 7
Computerised systems, validation and data integrityF3	15%≈ 6 items	≈ 6
Data capture, cleaning and query managementF4	18%≈ 7 items	≈ 7
External data, medical coding and reconciliationF5	13%≈ 5 items	≈ 5
Data review, centralised monitoring and database lockF6	10%≈ 4 items	≈ 4
Submission data standards and data privacyF7	8%≈ 3 items	≈ 3
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

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
1. Locked.What clinical data management is, and where it sitsLocked
  On completion you will be able to
  - R Describe the clinical data life cycle from protocol to locked dataset.
  - R Name the parties in the data ecosystem — sponsor, investigator and institution, CRO and other service providers, central laboratory, eCOA vendor, imaging core lab, IRT vendor, biostatistics — and state what each contributes.
  - R Distinguish clinical data management from clinical monitoring, pharmacovigilance, biostatistics and regulatory affairs.
  - A Locate the data management responsibilities within ICH E6(R3), naming §2.12, §3.16 and §4.
  - R State the non-equivalence of CLDP (CASRAI) and DAMA International's Certified Data Management Professional (CDMP®), and of CLDF/CLDP and SCDM's CCDA/CCDM/CCDS.
Module 2
F-M2
1 lesson
1. Locked.Source records, data acquisition tools and the transcription problemLocked
  On completion you will be able to
  - R Define source records using the E6(R3) glossary and give five examples spanning paper, EHR, participant-entered and machine-generated records.
  - R Define data acquisition tool (DAT) and explain why the CRF is a subset of it.
  - R Define certified copy and state what makes a copy certified.
  - A Classify a given record as source, transcribed, derived or reported.
  - A State the six record attributes required by E6(R3) §2.12.2 and apply them to a defective record.
  - N Identify unnecessary transcription steps in a described workflow and propose their removal.
Module 3
F-M3
1 lesson
1. Locked.Reading a protocol and building the data mapLocked
  On completion you will be able to
  - A Extract from a protocol every assessment, its visit, its source and its destination.
  - A Build a schedule-of-assessments-to-CRF mapping table.
  - R State what a data management plan contains and its standing under E6(R3) §3.16.1(c).
  - N Identify data specified for collection that no stated objective requires.
Module 4
F-M4
1 lesson
1. Locked.Data collection instrumentsLocked
  On completion you will be able to
  - R State the core CRF design conventions and the failure each prevents.
  - A Critique a defective eCRF page and list its faults.
  - R Explain what CDASH is, name the current CDASH Model and Implementation Guide versions, and state where CDASH sits relative to SDTM.
  - A Write CRF completion guidance for three fields, including for "not done", "not applicable" and "unknown".
  - A Handle partial and unknown dates.
Module 5
F-M5
1 lesson
1. Locked.Data capture, cleaning and queriesLocked
  On completion you will be able to
  - A Enter and verify data against source, scaling verification to criticality.
  - A Triage a query queue and write queries that resolve first time.
  - A Apply the E6(R3) §4.2.4 conditions to a proposed data correction.
  - R Explain the difference between a hard stop, a soft warning and a back-end query, and when each is appropriate.
  - N Given query metrics, distinguish a failing site from a failing edit check.
Module 6
F-M6
1 lesson
1. Locked.Systems, access, audit trails and data integrityLocked
  On completion you will be able to
  - R State what an audit trail must record, per the E6(R3) glossary.
  - R State the circumstances in which an audit trail may be modified, and the documentation required.
  - A Read an audit trail extract and reconstruct the sequence of events.
  - R Describe role-based access, permission review, and revocation on role change.
  - R Name the three subparts of 21 CFR Part 11 (US) and state what each governs; name the international instrument (ICH E6(R3) §4.3) that applies regardless of jurisdiction.
Module 7
F-M7
1 lesson
1. Locked.Where the data goes: standards, privacy and lockLocked
  On completion you will be able to
  - R Name SDTM, ADaM, Define-XML and CDASH and state the purpose of each.
  - R State the preconditions for database lock.
  - R Explain why a participant code is not anonymisation.
  - R Name the two lawful HIPAA de-identification methods (US) and the GDPR position that pseudonymised data remains personal data (EU/UK).

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 Data Management

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

CLIP (CASRAI)Professional

Clinical Data Management — Professional

Domains: 7
Exam items: 39
Cut score: 70%

$349USD

View credential

All CASRAI credentials

Common questions

About CLIF (CASRAI)

What is clinical data management certification?

It attests examined competence in collecting, cleaning, coding and locking clinical trial data to a standard a regulator would accept. The CASRAI credential covers CDASH, EDC build and validation, query management, medical coding, reconciliation and submission standards.

Do I need CDISC knowledge for clinical data management?

Yes. CDISC standards govern how trial data is structured for submission, and the CASRAI syllabus covers CDASH for collection and SDTM/ADaM with Define-XML for submission.

Is clinical data management a good career?

It is a specialist role with a defined body of knowledge and a clear standards base, which is precisely why an examined credential is worth holding rather than a course-completion certificate.