RARP (CASRAI)

Regulatory Affairs for Research Sites Certification — Professional

LevelProfessionalRARRARP (CASRAI)

92 h

Nominal

Self-paced study

Lessons

10 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 RARP (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

Regulatory Affairs for Research Sites — Professional

and is admitted to the designationRARP (CASRAI)

Verify atcasrai.org/verify/CASRAI-RAR-2026-RT16JZ

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

RARP (CASRAI) — Regulatory Affairs for Research Sites, Professional

CASRAI·Issued Mar 2026·Credential ID CASRAI-RAR-2026-RT16JZ

casrai.org/verify/CASRAI-RAR-2026-RT16JZ

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 weights8 domains · 39 scored items
Domain	Weight	Items
Determining the regulatory pathwayP1	18%≈ 7 items	≈ 7
IND preparation, maintenance and lifecycleP2	16%≈ 6 items	≈ 6
IDE preparation and the risk determinationP3	13%≈ 5 items	≈ 5
Safety reporting as a regulatory submissionP4	13%≈ 5 items	≈ 5
Financial disclosure and investigator conflictsP5	8%≈ 3 items	≈ 3
Human-subject protection regulation, appliedP6	12%≈ 5 items	≈ 5
Registration, results disclosure and transparencyP7	10%≈ 4 items	≈ 4
Agency interaction, expanded access, inspection and the regulatory fileP8	10%≈ 4 items	≈ 4
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

10 modules, 10 lessons

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

10 modules · 10 lessons · 92 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-M1
1 lesson · 14 h
1. Locked.Making and defending the IND determination14 h · Locked
  On completion you will be able to
  - Construct a written IND-necessity determination addressing each of the five § 312.2(b)(1) conditions separately.
  - Evaluate the sufficiency of a determination written by someone else.
  - Judge when a question exceeds the institution's competence and draft the § 312.2(e) request.
  - Design an institutional determination process and defend its controls.
  - Critique the common shortcuts — "it's off-label so it's practice of medicine", "we'll file an IND to be safe", "the IRB decided it's exempt" — and state what is wrong with each.
Module 2
P-M2
1 lesson · 8 h
1. Locked.Making and defending the risk determination8 h · Locked
  On completion you will be able to
  - Construct an SR/NSR determination with the two findings stated separately for each of limbs (1)–(3).
  - Draft the § 812.2(b)(1)(ii) explanation to the IRB.
  - Apply § 812.150(b)(9) where the IRB disagrees.
  - State accurately what § 812.66 does and does not provide.
Module 3
P-M3
1 lesson · 13 h
1. Locked.Building the IND13 h · Locked
  On completion you will be able to
  - Assemble an IND to the § 312.23(a) order.
  - Exercise the discretion § 312.22(b) contemplates and justify the level of detail chosen for each section.
  - Apply § 312.22(d)'s sponsor-investigator relief and identify what a letter of cross-reference must cover.
  - Draft a protocol containing the seven § 312.23(a)(6)(iii) elements.
  - Determine whether an investigator's brochure is required.
Module 4
P-M4
1 lesson · 9 h
1. Locked.Maintaining the IND9 h · Locked
  On completion you will be able to
  - Classify a proposed change as a new protocol, a protocol change, an information amendment or none of these.
  - Sequence FDA submission and IRB approval correctly.
  - Apply the immediate-hazard provision.
  - Compile a § 312.33 annual report and calculate its due date.
  - Describe the effect of a clinical hold and the routes out of one.
Module 5
P-M5
1 lesson · 8 h
1. Locked.Building and maintaining the IDE8 h · Locked
  On completion you will be able to
  - Assemble an IDE application to § 812.20(b).
  - Draft an investigational plan to § 812.25.
  - Classify a mid-study change and route it under § 812.35.
  - Compare the § 812.30(a) and § 812.40(b)/§ 312.40(b) commencement structures.
Module 6
P-M6
1 lesson · 11 h
1. Locked.Safety reporting as a submission11 h · Locked
  On completion you will be able to
  - Apply the three-part § 312.32(c)(1)(i) threshold.
  - Identify which clock applies and state what starts it.
  - Prepare an IND safety report and confirm distribution to all participating investigators.
  - Apply the § 812.46 and § 812.150(b) device obligations.
  - Separate the site's obligations from the sponsor's on a study where the institution is both.
Module 7
P-M7
1 lesson · 6 h
1. Locked.Financial disclosure6 h · Locked
  On completion you will be able to
  - Identify the Part 54 clinical investigators on a described study.
  - Classify an arrangement against the four § 54.2 interests.
  - Apply the $50,000 and $25,000 thresholds and identify the two interests with no threshold.
  - Explain why the site is not the filer.
Module 8
P-M8
1 lesson · 10 h
1. Locked.Consent, the IRB and multi-site arrangements, applied10 h · Locked
  On completion you will be able to
  - Construct a consent document satisfying the governing regime and annotate each element with its source.
  - Determine and document which regime governs and which rule is stricter.
  - Advise on continuing review for an FDA-regulated study.
  - Advise on IRB arrangements for a multi-site FDA-regulated study.
  - Execute the § 50.24 procedural requirements.
Module 9
P-M9
1 lesson · 7 h
1. Locked.Registration, results and the responsible party7 h · Locked
  On completion you will be able to
  - Classify a portfolio of trials for ACT status with documented reasoning.
  - Execute a PI responsible-party designation and recognise when it must be withdrawn.
  - Manage the registration, results, update and delayed-submission clocks.
  - Advise an institution on its exposure under § 11.66.
Module 10
P-M10
1 lesson · 6 h
1. Locked.Meetings, expanded access, inspection and the file6 h · Locked
  On completion you will be able to
  - State accurately what meetings § 312.47 provides for.
  - Prepare a single-patient expanded access submission and identify who becomes the sponsor-investigator.
  - Apply § 312.8's charging requirements.
  - Prepare a site and a sponsor-investigator for inspection.

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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