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Separating sponsor decision rights by issue and impact

Being informed about a decision does not establish who may make it.

Representative research photograph: Separating sponsor decision rights by issue and impact
Photo: U.S. Army Europe Images from Heidelberg, Germany · License: CC BY 2.0 · Cropped and resized.
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Being informed about a decision does not establish who may make it. Budget, scientific design and participant safety require different expertise. A decision-rights table is a management aid; it does not transfer investigator or independent committee responsibilities to the sponsor.

Decision framework

Start with recurring decisions such as opening another site, changing contracted scope, replacing a critical supplier and accepting a late deliverable. Separate the person preparing the proposal, the scientific reviewer, the financial approver and the implementation owner. Record deputy arrangements and conditions for escalation.

Worked example

For example, logistics may propose an alternative courier at the same price. If sample conditions and custody records could change, purchasing approval alone is insufficient assessment. Laboratory and quality owners evaluate technical suitability; the project manager coordinates the approved transition. An unchanged price does not demonstrate an absence of operational impact.

Implementation checks

  • Test the authority table against an actual delay decision and identify any responsibility that remains unassigned.
  • Specify the decision owner's deputy, delegated limits and the location of the recorded decision before an absence occurs.
  • Show options, uncertainty and potential participant effects in the evidence package provided to the decision owner.

Acceptance and boundaries

Accept the table when different team members route the same event consistently. Do not place urgent safety action in an ordinary financial approval queue. Review the arrangement alongside the protocol, contracts and local requirements; this example is not a universal legal allocation of duties.

Frequently asked questions

Can one approver make every decision?
Only within their authority and expertise; scientific and independent responsibilities need separate consideration.
When should the table change?
Retest affected decision routes whenever scope, staffing, suppliers or deputy arrangements change.

Sources

  1. EMA — ICH E6 good clinical practice
  2. WHO — Guidance for best practices for clinical trials