Query a trial protocol

Upload a clinical investigation plan or sponsor protocol and ask targeted operational questions about eligibility, safety reporting, or deviations, with every answer citing the governing section and page. Use it to get operationally ready before first patient.

Prompt

A research nurse at a cancer trials unit prepares to register patients into one cohort of a Phase 1 oncology trial.

I have uploaded the clinical investigation plan for this trial. Please answer the following questions based only on the protocol document:

1. What are the specific inclusion and exclusion criteria for patients registering into Cohort F?
2. What is the treatment sequence for patients in Cohort F who receive Trastuzumab and Pertuzumab together? Are there any sequencing restrictions stated?
3. What is the required reporting timeline for Grade 3 adverse events in this protocol? What information must be included in the report?
4. Is there any restriction on mixing TDM1 with glucose solutions? If so, which section states this?

For each answer, cite the specific section number and page where the information appears.

What to add to your library

• Required: the clinical investigation plan, sponsor protocol, or IND protocol as a PDF in your library or attached to the chat.
• Optional: earlier protocol versions, so Anara can flag where they differ from the current one.
• Optional: a patient's screening data, to check it against the inclusion and exclusion criteria.

What you get

• A direct answer to each operational question.
• The exact section number and page reference for every answer, so you or a monitor can verify it in minutes.

Follow-ups

Check a specific patient's eligibility.

My patient is a 52-year-old female with HER2-positive breast cancer, prior treatment with trastuzumab emtansine, and a current LVEF of 52%. Based only on this protocol, is she eligible for Cohort F? Walk through each inclusion and exclusion criterion and tell me which she meets, which she does not meet, and which require additional information to assess.

Confirm what a deviation requires.

A patient in Cohort F received their Cycle 2 infusion one day outside the protocol-specified window due to a scheduling error at the infusion center. Based on the protocol, is this a protocol deviation? What does the protocol require be done in this situation, and within what timeframe?

Tips

• Ask with specific detail (cohort, AE grade, drug name) and number multi-part questions so each is answered in order.
• Answers reflect only the uploaded text. Upload any site-specific addendum, or answers may not match your site.
• Always check the cited section before a patient care decision. Eligibility judgment stays with you and the principal investigator.
• When an amendment arrives, upload it alongside the original and ask which answers would change.