CTBP (CASRAI)
Clinical Trial Budgeting & Finance Certification — Professional
What you earn
The credential itself
Pass the examination and CASRAI issues this certificate and the post-nominal CTBP (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 Trial Budgeting & Finance — Professional
and is admitted to the designationCTBP (CASRAI)
Certifications
CTBP (CASRAI) — Clinical Trial Budgeting & Finance, Professional
CASRAI·Issued Mar 2026·Credential ID CASRAI-CTB-2026-BEDF7O
casrai.org/verify/CASRAI-CTB-2026-BEDF7O
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 |
|---|---|---|---|
| Financial architecture of clinical research at a site or institution1 | 8%≈ 1 item | ≈ 1 | |
| Protocol cost analysis and the schedule of events2 | 14%≈ 1 item | ≈ 1 | |
| The coverage-analysis interface3 | 8%≈ 1 item | ≈ 1 | |
| Costing methods: per-participant, effort-based, unit cost and overhead4 | 16%≈ 1 item | ≈ 1 | |
| Hidden, variable and commonly-missed costs5 | 14%≈ 1 item | ≈ 1 | |
| Clinical trial agreement financial terms and sponsor/CRO negotiation6 | 14%≈ 1 item | ≈ 1 | |
| Invoicing, milestones, receivables and cash flow7 | 14%≈ 1 item | ≈ 1 | |
| Amendments, reconciliation, closeout and portfolio financial performance8 | 12%≈ 1 item | ≈ 1 | |
| Total | 100% | 6 |
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 · 90 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
1
1 lesson · 6 h
- Locked.The financial architecture of clinical research6 h · Locked
On completion you will be able to
- On completion the candidate can:
- 1.1 Distinguish industry-sponsored, federally funded, foundation-funded and investigator-initiated studies by their financial logic, and state for each whether the site is being reimbursed for cost or paid a negotiated price.
- 1.2 Map the flow of funds for a given study from ultimate funder to the performing department, naming each intermediary and the obligation it carries.
- 1.3 Identify which institutional function owns each stage of the clinical trial financial lifecycle at a described institution, and locate the handoffs where financial information is lost.
- 1.4 Explain why a clinical trial, a sponsored grant and a clinical service line are accounted for differently at the same institution.
- 1.5 Contrast the bilateral-negotiation model of trial costing with the national-attribution model used in publicly funded systems.
Module 2
2
1 lesson · 10 h
- Locked.Reading a protocol for cost10 h · Locked
On completion you will be able to
- On completion the candidate can:
- 2.1 Extract a complete procedure and activity inventory from a full protocol, including items appearing only in narrative text.
- 2.2 Locate cost-relevant requirements in the ancillary documents — laboratory manual, pharmacy manual, imaging charter, informed consent form — that the protocol body cross-references but does not restate.
- 2.3 Identify the protocol features that drive staff time rather than procedure count: timing windows, sequencing constraints, fasting requirements, required qualification level of the performing staff, and required presence of the investigator.
- 2.4 Quantify staff time per visit by role, and defend the estimate.
- 2.5 Identify obligations extending beyond the treatment period.
- 2.6 Categorise every identified cost as per-visit, per-event, per-participant one-off, or study fixed.
Module 3
3
1 lesson · 8 h
- Locked.Building the reconciled schedule of events8 h · Locked
On completion you will be able to
- On completion the candidate can:
- 3.1 Construct a reconciled schedule of events as a costing artefact, distinct from the protocol's schedule of assessments.
- 3.2 Reconcile discrepancies between the protocol table, the protocol body and the ancillary manuals, and document the resolution and its basis.
- 3.3 Represent conditional and branching activity (tests performed only on a subset, procedures repeated until a criterion is met, optional sub-studies) correctly in a costing structure.
- 3.4 Produce a schedule of events that can serve simultaneously as the basis for the budget and as the input to a coverage analysis.
Module 4
4
1 lesson · 7 h
- Locked.The coverage-analysis interface7 h · Locked
On completion you will be able to
- On completion the candidate can:
- 4.1 Interpret a completed billing grid and state, for each line, which payer the line has been assigned to.
- 4.2 Derive the sponsor budget from the sponsor-assigned lines and demonstrate that no third-party-payer line has been priced into it.
- 4.3 Detect double-billing exposure and unfunded-cost exposure in a budget/grid pair.
- 4.4 Sequence coverage analysis, budget development and contract negotiation correctly within study start-up.
- 4.5 Reconcile the budget, the billing grid and the informed consent cost language and identify contradictions between them.
- 4.6 Escalate a coverage question rather than resolving it.
Module 5
5
1 lesson · 10 h
- Locked.Costing I: per-participant and unit costing10 h · Locked
On completion you will be able to
- On completion the candidate can:
- 5.1 Build a complete per-participant cost from a reconciled schedule of events, with visit-level subtotals.
- 5.2 Apply institutional unit costs and price-list rates correctly, and identify when a research rate legitimately differs from the clinical rate.
- 5.3 Derive a fully loaded hourly staff rate from salary, fringe and available productive hours, and explain why each adjustment is made.
- 5.4 Cost the procedures performed by service departments rather than the study team, and obtain and validate those figures.
- 5.5 Document a per-participant cost so that a third party can audit the derivation.
Module 6
6
1 lesson · 9 h
- Locked.Costing II: effort, overhead and the fixed-cost block9 h · Locked
On completion you will be able to
- On completion the candidate can:
- 6.1 Build an effort-based cost for roles that do not decompose into per-visit units, and justify the effort percentage.
- 6.2 Apply the rule that each role is captured by exactly one costing method, and detect double-counting where it is violated.
- 6.3 Calculate overhead correctly on a stated base, and state what the base excludes.
- 6.4 Distinguish the federally negotiated F&A rate from an institutional industry-trial overhead rate, and explain why they can properly differ.
- 6.5 Build the study fixed-cost block and defend recovering it independent of enrolment.
- 6.6 Identify pass-through costs and apply the institution's pass-through overhead treatment.
Module 7
7
1 lesson · 6 h
- Locked.Enrolment risk, break-even and scenario modelling6 h · Locked
On completion you will be able to
- On completion the candidate can:
- 7.1 Model total study financial performance at target, realistic and floor enrolment.
- 7.2 Calculate the break-even participant number from the fixed-cost block and the per-participant contribution.
- 7.3 Restructure a budget to shift recovery from enrolment-dependent to enrolment-independent, and quantify the effect on break-even.
- 7.4 Apply multi-year escalation and justify the basis used.
- 7.5 Advise on study feasibility in financial terms, including recommending against participation.
Module 8
8
1 lesson · 10 h
- Locked.The costs nobody puts in the template10 h · Locked
On completion you will be able to
- On completion the candidate can:
- 8.1 Identify the commonly-omitted cost categories systematically rather than by recall, using a structured taxonomy.
- 8.2 Price screen failures and re-screens, and select an appropriate screen-failure provision for a given protocol.
- 8.3 Construct an unscheduled-visit recovery mechanism that does not require a contract amendment on each occurrence.
- 8.4 Price service-department set-up fees and obtain them from the departments concerned.
- 8.5 Price the post-close-out long tail: archiving, long-term follow-up, system access, and audit support.
- 8.6 Price sponsor-behaviour-driven costs — monitoring support, query volume, and audit response.
- 8.7 Administer participant stipends and expense reimbursement, and identify the reporting and administrative obligations they create.
- 8.8 Route costs that are not the site's to bear.
Module 9
9
1 lesson · 8 h
- Locked.The clinical trial agreement as a financial instrument8 h · Locked
On completion you will be able to
- On completion the candidate can:
- 9.1 Extract every financially consequential provision from a clinical trial agreement, including provisions outside the budget exhibit.
- 9.2 Analyse payment-trigger language and identify triggers the site does not control.
- 9.3 Quantify the cash-flow cost of a holdback provision.
- 9.4 Analyse the subject-injury article for uncosted institutional liability and for consistency with the informed consent document.
- 9.5 Analyse termination provisions for recoverability of work in progress and non-cancellable commitments.
- 9.6 Identify indirect financial consequences of indemnification, insurance, publication and record-retention provisions.
Module 10
10
1 lesson · 6 h
- Locked.Negotiating with sponsors and CROs6 h · Locked
On completion you will be able to
- On completion the candidate can:
- 10.1 Prepare a negotiation position with items ranked by financial value and by expected resistance.
- 10.2 Distinguish negotiating with a sponsor from negotiating with a CRO, and identify what a CRO cannot agree without escalation.
- 10.3 Justify a budget position from the cost analysis rather than by assertion.
- 10.4 Identify institutional non-negotiables and hold them.
- 10.5 Recognise and respond to standard sponsor budget-template omissions.
- 10.6 Construct a recommendation to decline a study on financial grounds.
Module 11
11
1 lesson · 6 h
- Locked.Invoicing, receivables and cash flow6 h · Locked
On completion you will be able to
- On completion the candidate can:
- 11.1 Construct an invoicing schedule from an agreement's payment terms.
- 11.2 Distinguish automatically-triggered from manually-invoiced items and build the control that ensures the latter are invoiced.
- 11.3 Reconcile payments received against payments due at visit level and identify short payments.
- 11.4 Manage clinical trial accounts receivable through ageing, escalation and dispute.
- 11.5 Forecast study cash flow and identify the maximum negative position.
- 11.6 Administer participant payments with adequate control.
- 11.7 Distinguish cash received, revenue recognised and funds available to spend, and explain the difference to a non-financial audience.
Module 12
12
1 lesson · 4 h
- Locked.Amendments, reconciliation, closeout and portfolio performance4 h · Locked
On completion you will be able to
- On completion the candidate can:
- 12.1 Assess a protocol amendment for prospective and retrospective financial impact and prepare a budget amendment.
- 12.2 Perform study reconciliation at participant and visit level.
- 12.3 Execute financial close-out including holdback release and receivable disposition.
- 12.4 Determine residual balance disposition and interpret a residual balance diagnostically.
- 12.5 Produce portfolio-level financial reporting and use realised cost to calibrate future budgets.
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.
