22.2 Contracts, Budgets and Operational Feasibility

ACRP CCRA Certified Clinical Research Associate Study Guide 2026 Exam

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1 Chapter 1: Exam Format, Eligibility and Registration

1.1 Exam Format, Eligibility and Current References 1.2 Registration, Fees and Candidate Decisions

2 Chapter 2: CRA Responsibilities and Study Planning

2.1 The CRA Role, Data Integrity and Product Oversight 2.2 Official Blueprint and Study Strategy

3 Chapter 3: Protocols, Endpoints and Trial Design

3.1 Protocol Elements and Endpoint Hierarchy 3.2 Endpoint Interpretation and Eligibility Rationale 3.3 Eligibility Verification and Trial Designs

4 Chapter 4: Bias Control, Blinding and Product Information

4.1 Bias, Randomisation and Comparator Controls 4.2 Unblinding and Investigator Brochure Content 4.3 Reference Safety Information and IB Updates

5 Chapter 5: Estimands and Device Instructions

5.1 Estimands and Intercurrent Events 5.2 Device Instructions, Configuration and Training

6 Chapter 6: Ethical Foundations and Independent Oversight

6.1 Ethical Foundations and the 2024 Declaration of Helsinki 6.2 Vulnerability, Voluntariness and Compensation 6.3 IRB/IEC Composition and Independent Review

7 Chapter 7: Ethics Communication and Informed Consent

7.1 Ethics Reporting, Approval Status and Version Control 7.2 Informed Consent Information and Meaningful Choice 7.3 Consent Documentation, Special Circumstances and Updates

8 Chapter 8: Recruitment, Retention and Confidentiality

8.1 Ethical Eligibility, Recruitment and Retention 8.2 Privacy, Confidentiality and Appropriate Access

9 Chapter 9: Safety Definitions and Classification

9.1 Adverse Event Definitions and Actual Life-Threatening Risk 9.2 Seriousness, Severity and Medical Importance 9.3 Causality, Expectedness and Reference Safety Information

10 Chapter 10: Safety Detection, Reporting and Oversight

10.1 Detecting Events, AESIs and Collection Windows 10.2 Expedited Reporting and the Sponsor Awareness Clock 10.3 Immediate Site Reporting and Independent Safety Oversight

11 Chapter 11: Follow-Up, Adherence and Conflicts

11.1 Safety Communications, Reconciliation and Follow-Up 11.2 Adherence, Discontinuation and Participant Choice 11.3 Conflicts of Interest and Prorated Payments

12 Chapter 12: Development Stages and Product Management

12.1 Nonclinical Background and Human Pharmacology 12.2 Exploratory, Confirmatory and Therapeutic-Use Studies 12.3 Product Storage, Labelling and Excursion Response

13 Chapter 13: Accountability, Integrity and Regulatory Status

13.1 Product Accountability and Adherence Calculations 13.2 Potential Fraud, Misconduct and Evidence Preservation 13.3 Submissions, Authorisation Status and Trial Reporting

14 Chapter 14: Current GCP Principles and Delegation

14.1 The Eleven Current GCP Principles 14.2 Proportionality and Investigator Oversight 14.3 Delegation, Qualifications and Task Authority

15 Chapter 15: Oversight, Protocol Control and Amendments

15.1 Clinical Oversight and Immediate-Hazard Changes 15.2 Deviation Classification and Resolution

16 Chapter 16: Implementation and Trial Responsibilities

16.1 Amendment Implementation and Communication 16.2 Sponsor, Investigator and Service-Provider Roles

17 Chapter 17: Quality Planning, Root Causes and CAPA

17.1 Quality Planning and Risk Management 17.2 Root Cause Analysis and CAPA Design 17.3 CAPA Implementation and Effectiveness Verification

18 Chapter 18: Risk Assessment and Monitoring Methods

18.1 Risk Assessment and Centralised Surveillance 18.2 Monitoring Methods and Source Review

19 Chapter 19: Quality Metrics, Plans and Communication

19.1 KRIs, Acceptable Ranges and Trial-Level Quality 19.2 Monitoring Plans, Co-Monitoring and Communication

20 Chapter 20: Site Qualification and Readiness

20.1 Site Qualification and Investigator Capacity 20.2 Recruitment Feasibility and Evidence-Based Site Selection 20.3 Site Readiness and Activity-Specific Release

21 Chapter 21: Initiation, Equipment and Supplies

21.1 Initiation Training and Readiness Walkthroughs 21.2 Equipment, Maintenance and Study Supplies

22 Chapter 22: Samples, Diagnostics and Financial Feasibility

22.1 Specimens, Diagnostic Results and Rater Quality 22.2 Contracts, Budgets and Operational Feasibility

23 Chapter 23: Interim Monitoring and Reporting

23.1 Interim Visit Preparation and Consent Review 23.2 Monitoring Eligibility, Safety and Products 23.3 Investigator Debrief and Monitoring Reports

24 Chapter 24: Essential Records, Audits and Findings

24.1 Essential Records and Site/Sponsor Reconciliation 24.2 Version History, Resolution Evidence and Noncompliance 24.3 Audits, Inspections and Closure Planning

25 Chapter 25: Close-Out, Retention and Destruction

25.1 Close-Out, Archiving and Continuing Obligations 25.2 Retention, Destruction and Long-Term Access

26 Chapter 26: Source Records and Good Documentation

26.1 Source Records and Foundational ALCOA Principles 26.2 Good Documentation, Completeness and Corrections 26.3 Source Access, Certified Copies and Context

27 Chapter 27: Electronic Systems, Metadata and Queries

27.1 EDC Design and Fit-for-Purpose Systems 27.2 Audit Trails, Electronic Outcomes and Device Choice 27.3 Queries, Coding and Supported Clinical Meaning

28 Chapter 28: Dataset Finalisation and Critical Data

28.1 Safety Reconciliation and Dataset Finalisation 28.2 Critical Data, Acquisition Tools and Interim Findings

22.2 Contracts, Budgets and Operational Feasibility

Key Takeaways Explain This Topic AI

Financial arrangements should support actual protocol work and relevant responsibilities.

A protocol amendment can change workload and resource needs.

Commercial negotiation does not itself authorise amended research activities.

Last updated: October 2026

Contracts, Budgets and Operational Feasibility

The ECO includes contracts and budgets, participant compensation and site payments. A CRA should understand how these arrangements affect readiness, responsibilities and conduct while respecting their own authority. Financial pressure must not create unauthorised procedures, inappropriate participant charges, undisclosed conflicts or incentives to hide missing work. The signed agreement and approved protocol should describe a workable relationship.

A clinical trial agreement can address activities, financial arrangements, responsibilities, injury-related provisions, access to records, confidentiality, publication and retention. Particular clauses and signatories depend on the parties and applicable requirements. ICH does not mandate one named commercial contract template for every trial. The monitor verifies relevant arrangements and escalates unresolved conditions through the designated sponsor/institutional functions.

Budget the actual protocol work

A visit label can hide substantial work: prescreening, consent, eligibility review, specialised assessments, product handling, sample processing, data entry, query response and follow-up. Feasibility should consider staff time, equipment, service-provider support and participant burden. A budget that funds only a routine clinic appointment may not support a complex timed research visit safely.

Distinguish ordinary care from research-specific activities in planning and participant information. Do not assume every procedure is covered identically or promise a participant free treatment without evidence. Injury treatment/compensation and payment for participation are different subjects. The appropriate consent materials should explain relevant expenses and arrangements accurately.

A transparent budget example

Assume a hypothetical schedule pays the site 300 currency units for each of four completed research visits and a separately agreed 150-unit startup payment. For a participant completing all four visits, visit payments total 4 × 300 = 1,200 units ; adding startup produces 1,350 units for this simplified example. These numbers are illustrative and are not ACRP rates or a recommended market price.

Now suppose the agreement pays for completed procedures rather than whole visits, and one assessment was not performed. The site cannot infer the invoice amount from the visit label alone. Review the actual milestones, supporting records and contract terms with the responsible financial staff. A data-entry record saying visit complete is not proof every billable activity occurred.

Site payments and participant payments

Payment flow Governing evidence Monitoring concern

Sponsor/CRO to institution Agreement, milestones and supported invoices Payment claims reflect actual eligible work

Institution to participant Ethics-reviewed schedule and participant information Timely prorated payment without pressure to remain

Expense reimbursement Approved process and supporting evidence as applicable Reasonable access without unnecessary burden

Injury treatment/compensation Applicable arrangements and consent information Participants understand protections and contacts

The CRA may identify discrepancies but should not negotiate a new rate, authorise an uncontracted procedure or determine legal indemnity without assigned authority. Refer commercial questions appropriately while ensuring they do not leave a participant-safety issue unresolved. A budget disagreement is not permission to omit required safety assessments silently.

Amendments and change in workload

A protocol amendment may add visits, procedures, training or data requirements. Assess operational capacity and whether contract/budget changes are needed. Financial negotiation does not itself authorise implementation of amended research activities. Similarly, an approved amendment does not mean the site has adequate staff or supplies for it. Coordinate the permission, resources and implementation process.

If a site reports that it cannot perform a newly required assessment, document the concern and involve the sponsor before continued noncompliance. Consider whether support, a permitted alternative, revised feasibility or another controlled action is needed. Do not teach staff to label the assessment not applicable merely to avoid raising a resource problem.

Recruitment estimates and capacity

Project feasibility includes access to eligible participants, competing trials, realistic consent rates, site/committee timelines, staffing and follow-up burden. Use evidence from comparable work and the actual eligibility criteria. A site's reputation alone cannot establish that its proposed recruitment target is credible. Examine what assumptions turn a general patient population into an attainable study cohort.

An illustrative plan needs 18 participants in six months, averaging three enrolments monthly. If documented detailed prescreening identifies only two potentially eligible people a month before consent refusals and competing trials, the target is not supported by that evidence. The team may need a justified referral strategy, different site allocation or revised plan. The calculation is a feasibility warning, not proof that the site is incapable of all research.

Follow-through and records

Maintain relevant agreements, changes, communications and evidence under the appropriate essential-record process. Financial details can be confidential and need controlled access. Track unresolved matters with an owner and deadline, distinguishing an anticipated payment from an actual authorisation or completion record. At closure, confirm remaining contractual obligations and ongoing record access without implying that every financial dispute blocks all clinical close-out activities.

Official sources

Checked October 18, 2026: ICH E6(R3), Principles and Annex 1 , ICH E8(R1) .