CSOP (CASRAI)
Clinical Research Site Operations Certification — Professional
What you earn
The credential itself
Pass the examination and CASRAI issues this certificate and the post-nominal CSOP (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 Site Operations — Professional
and is admitted to the designationCSOP (CASRAI)
Certifications
CSOP (CASRAI) — Clinical Research Site Operations, Professional
CASRAI·Issued Mar 2026·Credential ID CASRAI-CSO-2026-IIKHQ0
casrai.org/verify/CASRAI-CSO-2026-IIKHQ0
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 |
|---|---|---|---|
| The site as a regulated operation: obligations, models and the ecosystemP1 | 10%≈ 7 items | ≈ 7 | |
| Feasibility, study selection and portfolio capacityP2 | 14%≈ 10 items | ≈ 10 | |
| Staffing, role delineation, delegation and the training systemP3 | 12%≈ 9 items | ≈ 9 | |
| The site quality management system: SOPs, document control and quality controlP4 | 12%≈ 9 items | ≈ 9 | |
| Contract and budget intake, and the financial operation of the siteP5 | 10%≈ 7 items | ≈ 7 | |
| Recruitment, community engagement, retention and participant experienceP6 | 12%≈ 9 items | ≈ 9 | |
| Essential records, the ISF and the TMF as a site functionP7 | 10%≈ 7 items | ≈ 7 | |
| Site infrastructure: investigational pharmacy, laboratory and specimen logistics, equipmentP8 | 12%≈ 9 items | ≈ 9 | |
| Inspection readiness, metrics, sponsor reporting and continuityP9 | 8%≈ 6 items | ≈ 6 | |
| Total | 100% | 74 |
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
12 modules, 12 lessons
Every lesson and every learning outcome is listed. The lesson bodies open on enrolment; nothing else about the course is withheld.
12 modules · 12 lessons · 110 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
M1
1 lesson · 8 h
- Locked.The site as a regulated operation8 h · Locked
On completion you will be able to
- By the end of this module the learner can:
- Identify which E6(R3) obligations attach to the investigator and institution as a standing capability rather than to a single study, and justify the identification from §2.1, §2.2, §2.3 and §3.7.1.
- Classify a described site into an operating model — academic medical centre unit, health-system department, independent site, network member, SMO client — and state what changes about employment, SOP ownership, contracting and inspection exposure.
- Explain the E6(R2) → E6(R3) structural changes that affect a site's documentation system, in particular the replacement of the §8 Essential Documents list by Essential Records and the Appendix C.3.1 essentiality test.
- Map the site's counterparties and state which obligations run to each.
Module 2
M2
1 lesson · 10 h
- Locked.Feasibility and the evidence behind a projection10 h · Locked
On completion you will be able to
- Construct a documented population denominator for a protocol from a named data source, and state its known error.
- Produce an enrolment projection with its assumptions exposed, and defend each assumption.
- Audit a completed feasibility questionnaire against the evidence that supports it and identify every answer that is an aspiration.
- Compile a competing-study inventory and identify mutual-exclusion effects.
Module 3
M3
1 lesson · 10 h
- Locked.Portfolio capacity and study selection10 h · Locked
On completion you will be able to
- Build a portfolio capacity model in hours and reconcile several studies' simultaneous §2.2 resource assertions against it.
- Identify, in a described portfolio, which resource assertion is false and state the evidence.
- Recommend acceptance or decline of a candidate study on portfolio grounds and document the decision.
- Measure start-up cycle time by stage and distinguish the stages the site controls from those it does not.
Module 4
M4
1 lesson · 10 h
- Locked.Staffing, delegation and the training system10 h · Locked
On completion you will be able to
- Design a role structure for a site of a given size and portfolio and justify the centralised/embedded choice.
- Operate a delegation system across concurrent studies and reconcile the delegation log against training, licensure, system access and protocol version.
- Diagnose a delegation finding and distinguish a supportable entry from an unsupportable one, citing Appendix C.3.1(m).
- Maintain a training matrix that is true, and identify what makes most of them untrue.
- Plan a handover that preserves regulatory continuity.
Module 5
M5
1 lesson · 8 h
- Locked.SOP architecture and document control8 h · Locked
On completion you will be able to
- Justify why a site's SOPs and validation records are essential records, citing Appendix C.2.12.
- Design an SOP hierarchy proportionate to a described site and defend the scope decisions against Principle 7.
- Operate document control such that the site can state which version was in force on a given date.
- Identify the control failures that produce version findings.
Module 6
M6
1 lesson · 8 h
- Locked.Quality control and deviation management at site level8 h · Locked
On completion you will be able to
- Distinguish quality assurance from quality control using the E6(R3) Glossary, and place monitoring correctly.
- Design site quality control that is built into conduct rather than applied afterwards.
- Classify a protocol deviation against the sponsor's §3.9.3 criteria and state who sets those criteria.
- Trend deviations across a portfolio and identify a process failure a single-study view would miss.
- State where the site's own quality work stops and independent audit begins.
Module 7
M7
1 lesson · 10 h
- Locked.Contract and budget intake10 h · Locked
On completion you will be able to
- Run an intake workflow from budget receipt to executed agreement and measure its cycle time by stage.
- Identify, in a supplied clinical trial agreement, the clauses that determine whether the study is operable, including the §3.6.3(d) direct-access clause and its extension to service providers.
- Build a per-patient budget from a schedule of activities and identify the costs the per-patient rate does not recover.
- Assess a study's effect on the site's aggregate financial position.
Module 8
M8
1 lesson · 10 h
- Locked.Recruitment and community engagement10 h · Locked
On completion you will be able to
- Design a recruitment strategy from a protocol's actual eligibility profile and specify the referral pathways it depends on.
- Measure conversion at each funnel step and diagnose where a strategy is failing.
- Determine what approvals a given piece of recruitment material requires and from whom.
- Apply the US screening-and-recruitment provision at 45 CFR § 46.116(g) and distinguish it from a § 46.116(f) waiver of consent.
- Distinguish community engagement from a recruitment campaign and state how each is resourced.
Module 9
M9
1 lesson · 8 h
- Locked.Retention, participant experience and decentralised elements8 h · Locked
On completion you will be able to
- Diagnose a retention failure from a supplied dataset and identify the drivers the site controls.
- Design the participant's experience of a visit and justify each choice against a retention driver.
- Distinguish withdrawal from the intervention, from follow-up, and from the use of already-collected data, and state that these are three separate decisions.
- Identify decentralised elements in a supplied protocol and state which site functions each displaces.
- State the current status of E6(R3) Annex 2 and explain why it is not yet a requirement.
Module 10
M10
1 lesson · 10 h
- Locked.Essential records, the ISF and the TMF10 h · Locked
On completion you will be able to
- Apply the Appendix C.3.1(a)–(n) essentiality test to a record that appears on no list, and justify the outcome.
- Produce the record required by Appendix C.2.4 of where essential records are located, including source records, for a multi-study site.
- Determine who retains the original of a given record under C.2.7, and when a certified copy may replace it.
- State the EU archiving obligation, to whom it runs, and for how long.
- Describe the TMF Reference Model accurately, including what it is not.
Module 11
M11
1 lesson · 12 h
- Locked.Pharmacy, laboratory, specimens and equipment12 h · Locked
On completion you will be able to
- Operate investigational product accountability as a site system and locate a break in a supplied record.
- Sequence the correct response to a temperature excursion and state who decides whether excursed product may be used.
- Distinguish a central laboratory's obligations from a local laboratory's in the same protocol and specify the interfaces the site must manage.
- Document specimen chain of custody and specify a compliant shipment.
- Maintain calibration and maintenance records and determine what happens to data generated by a device found out of calibration.
Module 12
M12
1 lesson · 6 h
- Locked.Inspection readiness, metrics and continuity6 h · Locked
On completion you will be able to
- Define inspection readiness operationally and assess a site against the definition on a day when no inspection is scheduled.
- Specify the site's operational response to an announced inspection — routing, notification, workspace, escort and scribe, document request logging.
- Build a site metric set in which every metric drives a decision, and discard those that do not.
- Write a performance narrative for a study that underperformed.
- Produce a continuity plan for the loss of a key person, a system or the premises.
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.
