Benefit — IRB continuing-review stance
What Snapshot-grade IRB evidence saves you at continuing-review
IRB continuing-review is not adversarial when the sponsor brings dated independent evidence + a remediation plan. It is adversarial when the sponsor is caught behind the disclosure.
The three moments where it matters
- Scheduled continuing-review submission. Sponsor discloses the AI-driven pattern + Snapshot record + remediation plan. Board approves continuing under conditions.
- Participant-complaint-triggered review. IRB opens ad-hoc review after a participant raises concern. Sponsor-initiated evidence reshapes the meeting.
- Auditor / accreditor inquiry (AAHRPP). Accrediting body applies equitable-selection criterion. Independent record supports accreditation-standing.
Dollar frame
Site-suspension cost: per-site recruitment-restart typically $250K-$1M. Multi-site suspension across a Phase III oncology trial stacks quickly — and enrollment-timeline delay carries lost-exclusivity cost of its own.
Accreditation-standing risk: AAHRPP-linked findings can affect the sponsor's ability to run trials at accredited institutions — a much larger indirect cost.
Preventive discipline cost: $499 Snapshot + investigator-review-hold on the affected patient group = the disclosure package IRBs accept.
Who at your org cares
- Chief Medical Officer — participant-safety narrative
- Head of Clinical Operations — site + IRB relationships
- Chief Compliance Officer — sponsor SOP + disclosure discipline
- General Counsel — participant-complaint-related risk
What "having it" looks like
Green: Snapshot on file. Sponsor-initiated IRB disclosure with dated evidence + remediation. Board approves continuing under conditions.
Red: IRB learns via participant complaint. Sponsor scrambles for records. Site-suspension risk crystallizes.
$499. 3 business days.
Dated evidence + 3 fix-first items = the disclosure package IRB continuing-review boards accept.
Buy $499