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Upload a clinical investigation plan or sponsor protocol and ask targeted operational questions: which patients in a cohort are eligible, what the safety reporting requirements are, whether a specific deviation scenario is permitted. Every answer cites the specific protocol section. For clinical research associates and research nurses who need to be operationally ready before first patient.

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1. Describe the task

You have been assigned to a new trial. The protocol is 180 pages. Your first patient is in two weeks. Before you can register that patient, before you can administer treatment, before you can handle a protocol deviation, you need to know the document well enough to answer specific operational questions without missing anything. Reading the full protocol linearly is not the same as being able to retrieve an answer quickly when a situation arises. Anara reads the uploaded protocol and answers your operational questions directly, citing the specific section, page, and passage. Eligibility questions, safety reporting timelines, deviation handling, mixing restrictions, cohort assignment: each answer points to the clause in the document that governs it. You do not have to search the table of contents or scan the appendices. Here a clinical research nurse at a cancer trials unit is preparing to register patients in Cohort F of a Phase 1 oncology trial and needs to confirm eligibility criteria, treatment sequencing, and AE reporting timelines before the first patient appointment. 
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.

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2. Give Anara context

Required context
  • The clinical investigation plan, sponsor protocol, or IND protocol as a PDF uploaded to your library or attached to the chat.
Optional context
  • The protocol amendment history if the document has been revised and you want to confirm you are working from the current version. Anara can flag where earlier versions differ if you upload both.
  • The patient’s screening data, if you are checking eligibility for a specific individual. Anara cross-references the patient’s characteristics against the inclusion and exclusion criteria.

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3. What Anara creates

A direct answer to each operational question, with the exact section number and page reference. Cited so you or a monitor can verify against the source document in minutes.

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4. Follow-up prompts

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Check a patient’s eligibility in detail

When you have a specific patient and want to run through every criterion. 
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.

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Confirm what a protocol deviation requires

When something has happened and you need to know what the protocol says to do next. 
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?

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Prepare for a site monitoring visit

When the monitor is coming and you want to review the protocol’s data collection and documentation requirements. 
What documentation does this protocol require for each patient visit in Cohort F? List the required source documents, the data points that must be captured at each visit, and any timing requirements specified. Cite the sections that govern each requirement.

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5. Tricks, tips, and troubleshooting

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How you word your prompt shapes what you get

Ask targeted operational questions with specific detail: cohort name, patient type, AE grade, drug name. “What are the eligibility criteria for Cohort F patients with prior anti-HER2 therapy?” returns the relevant clause. Number multi-part questions as in the primary prompt so Anara answers each in order. Include explicit instruction to cite section number and page.

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Check the output against your own understanding

Anara answers from the uploaded protocol text. If your site uses a locally adapted version or a site-specific addendum was not uploaded, the answers may not reflect your site’s conditions. Always cross-reference against the cited section before relying on it for a patient care decision. Clinical eligibility judgment remains yours and the principal investigator’s.

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What to do with the output next

Use the cited answers as the basis for your pre-activation checklist and confirm each cited section in your training log. For AE reporting, save the timeline answer as a note with the trial name and protocol version. When a new amendment arrives, upload it alongside the original and ask Anara to identify which answers would change.