Repeat the assessment
Screening assessment must be repeated at the study site.
Evidence within Protocol Intelligence
Don’t just make the choice.
Understand what supports it.
Enter the review with a clearer view of what supports the choice—and what still needs an answer. Explore what comparable studies changed and whether their reasons are relevant to yours. The examples below are illustrative.
Historical Amendment Intelligence
The original protocol
is only part of the story.
Inspect the original requirement, the later change and its documented rationale. Where the reason or outcome is unavailable, keep the gap visible.
FICTIONAL HISTORICAL EXAMPLE · HX-101
Review an existing assessment
A documented assessment from a referring site may be reviewed against the protocol’s requirements.
Reason recorded in the amendment
The fictional amendment summary records difficulty arranging repeat assessments before screening.
The question for your study: Could this assessment requirement create the same screening difficulty, and would reviewing a referring-site assessment be appropriate?
Examine the evidence and limitations
- Source
- Fictional HX-101 original protocol §5.1, amended protocol §5.1 and amendment summary §2. All three are prepared website examples.
- What remains unknown
- No screening-rate dataset or post-amendment outcome is supplied. The change does not establish that recruitment improved.
- Relevance to a new study
- Clinical context, population, assessment method and timing need specialist review. A historical amendment does not prove the original choice was wrong.
Source coverage can be incomplete. A registry update is not automatically a protocol amendment, and no amendment found does not mean no amendment occurred. Similarity is a reason to examine relevance, not to copy a clinical decision.
Explore the fictional amendment workflowHistorical retrieval is part of the planned product scope. Confirm document access, version coverage, permitted use and capabilities for your evaluation.
Evidence review
The reason is missing.
The team can see what needs review.
In this example, an exploratory procedure is listed without a clear purpose. The planned review also compares exact protocol, manual and data-specification versions when their instructions disagree. The responsible team sees what was checked, what remains unknown and who needs to respond.
This is a sample review question. It is not a recommendation to remove the procedure.
- Source
- What document, publication or record was supplied?
- Source details
- Can the team identify its author, version and date?
- Relevance
- What does this source support in this study?
- Assumption
- What is being treated as true but still needs checking?
- Missing information
- What remains unknown or uncertain?
- Review and decision
- Who reviewed the evidence, what did they decide and why? Keep that explanation with the protocol version.
Public clinical and scientific evidence
Keep the source
beside the protocol question.
The source categories below answer different questions. A previous trial may show what was done; it does not prove the same choice is right for your study. Live access and coverage must be confirmed for an evaluation.
Clinical trial registries
ClinicalTrials.gov and AACT, a database of ClinicalTrials.gov records, subject to access, permitted use and evidence checks.
Scientific evidence
PubMed, Europe PMC and permitted public or open-access literature. Publication type, source quality and relevance stay visible.
Regulatory context
FDA public guidance, reviews and labels; EMA public information; ICH guidance. Keep the issuing organisation, relevant country or region, date and document status visible.
Public study material
Original protocols, subsequent amendments, amendment summaries and clinical study reports where access and reuse are allowed. Dates, lineage and unavailable versions should remain visible.
Check source-by-source availability and limitations →
Source availability and scope
- Release availability
- Confirm which evidence sources are available for the exact product release and evaluation.
- Sample limitation
- The example of missing evidence does not include an original protocol, clinical source or source date.
- Source coverage
- For each type of source, confirm what can be accessed, how it may be used, when it was last updated and whether it is ready for the evaluation.
- Who interprets it
- A source or AI response is not a clinical conclusion. The responsible specialists examine where it came from, its relevance, the assumptions being made and what is still missing.
Regulatory context
Connect guidance to the protocol question it may affect.
Show the guidance document, its date and why it may be relevant.
The Sponsor’s regulatory and clinical professionals decide whether it applies and what action to take.
- 01 · Protocol itemPrimary endpoint
Rationale · Assumption
- 02 · EvidenceClinical evidence
Source name · Date and version · Limitations
- 03 · Regulatory contextWhat may apply?
FDA public material · ICH guidance · EMA public information
- 04 · Responsible team reviewRegulatory / Clinical
Does the guidance apply? · Which tests, statistics or population choices may be affected?
- 05 · Human decisionReviewed protocol version
Reason for the decision · What changed
The Sponsor’s regulatory and clinical professionals decide whether the guidance applies and what action to take. This example does not make a recommendation or record a completed review.
Regulatory sources and update status
Tenvia’s approach connects each protocol choice to its evidence, assumptions and related study decisions. The team can review relevant guidance, possible effects and who needs to decide.
Keep the issuing organisation, relevant region, title, date, version, status and access date visible. Confirm which sources and update checks are available for your product version and planned use.
Standards and regulatory boundariesExplore with your team
Bring the question and the evidence it needs.
Bring one protocol question. Examine the relevant sources, the assumptions being made, the information still missing and the specialists responsible for the decision.