22.2 Contracts, Budgets and Operational Feasibility

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

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).