Repeat the assessment
Screening assessment must be repeated at the study site.
CONCEPT DEMONSTRATION · FICTIONAL STUDY DATA
One change. Follow every consequence.
Choose a collection schedule, see its stated effects, examine prepared team perspectives and keep the reasoning with a draft decision.
Begin with one fictional RD-204 study question. This prepared example is not a live customer workspace, AI analysis or approval workflow.
START HERE · FICTIONAL RD-204 · 120 PARTICIPANTS
What do two more samples ask of the study?
Compare declared collection time, inspect the wider burden questions and follow a prepared team response.
Chapter 1 of 4 · You are the study lead
Two more samples. What else changes?
The moment / A protocol change lands with your team
“Could we collect exploratory blood samples at Weeks 8 and 12 as well?”
The draft currently includes one collection at Week 4. Explore what this request means across a fictional study of 120 participants.
Current draft
Collect an exploratory blood sample at Week 4.
Proposed additionCollect at Week 4, Week 8 and Week 12.
No setup. No sign-up. Make the choice and follow the reasoning.
Explore another question
Two more prepared examples.
These are independent fictional scenarios. They do not form a continuous customer study or demonstrate live AI, integrations or approvals.
SECOND EXAMPLE · FICTIONAL RD-204 AND HX-101
Should an earlier amendment change this draft?
Examine what the older study changed, what remains unknown and how specialists would review a related choice.
Draft decision revision 1 · You are the example study lead
Before you reuse it, see what changed.
A repeat screening assessment has been copied into the fictional RD-204 draft. A fictional predecessor, HX-101, later changed a related requirement. Explore whether that history matters here.
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.
THIRD EXAMPLE · FICTIONAL RD-204 · IMAGING WINDOW
Could this requirement work at the site?
Compare source versions, inspect an execution gap and consider prepared site and patient/public design perspectives.
Chapter 1 of 4 · Example study lead
One requirement. Three different instructions.
RD-204 proposes an MRI result before randomisation. The fictional protocol, imaging manual and data specification describe different windows, all anchored to randomisation.
- Draft protocol v0.2, §5.2
- MRI performed within 30 days before randomisation.
- Imaging manual draft v0.4, §3
- MRI performed within 45 days before randomisation.
- Data specification draft v0.1, MRI_DATE
- Entry allows 60 days before randomisation.