AI IND Authoring Software: Acceptance Checklist

This is a reusable procurement checklist for teams evaluating an IND drafting workflow. It is an Assyro editorial resource, not an FDA form, a regulatory submission checklist or a vendor benchmark. Assyro is the publisher and our first evaluation recommendation; every required capability still needs evidence. The sample below is fictional and has not been executed in a vendor product.

Use the annotated source-to-draft exercise

The illustration follows PR-08 revision 2 into both draft locations, then shows the controlled PR-08A amendment. The checklist includes missing investigator information, the conflicting working note and the final undated source with no established precedence. This is an expected-result illustration, not a screenshot or proof of product performance.

Download the editable workbook (XLSX)

The acceptance checklist

Use pass, fail, unresolved or outside agreed scope for each check. Record an observation and the responsible reviewer. An unanswered requirement remains unresolved; an excluded requirement must have an explicit scope decision.

Copy these rows into your evaluation record. Add application-specific requirements with your regulatory and quality owners before treating the record as a purchase gate. The checklist's purpose is to expose whether the offered workflow solves the agreed task, not to replace the sponsor's content decisions.

Set the IND scope before the demonstration

FDA describes an IND as containing several kinds of information, including nonclinical evidence, manufacturing information, and clinical protocols and investigator information. That breadth is why “draft an IND” is too imprecise as a software acceptance requirement. Identify the particular material your writers will produce and the source documents available to them. FDA IND overview.

Separate an initial application from maintenance of an existing application. Also distinguish a factual section draft from an integrated scientific assessment, a completed document from a published package, and publishing from transmission. Record the functions included in the proposed purchase and who performs the remaining work.

For example, an evaluation may cover preparing a specified narrative from approved source documents and returning it for expert review. It may leave technical publishing with the sponsor's existing provider. That is a legitimate scope if the handoff is usable; it should not be described as demonstrating the entire submission process.

If nonclinical reports enter the source packet, define their input and review contract with the nonclinical authoring guide.

For protocol-specific work, use the clinical protocol software evaluation to separate drafting assistance from study-design decisions.

Prepare a small packet that the team can independently review

Use nonconfidential material approved for the evaluation or explicitly fictional records. Include a controlled source, a working document with a conflicting value, a short output template, and a change introduced after the first draft.

Have the responsible domain reviewer define expected facts and required qualifications before seeing the generated result. This gives the team a way to detect omissions as well as incorrect statements. Reviewing only what appears in the output can miss information the tool left out.

Record the operator and any vendor assistance. If the vendor prepares the sources or configures the template, identify that contribution. A future operating estimate should include work your team will need to perform itself or purchase as a service.

For a separate Module 2.3 requirement, use the QOS authoring evaluation to test reconciliation with the selected quality dossier.

Worked case: the protocol identifier changes across the draft

The following fictional packet tests consistency and source authority without suggesting a clinical design or treatment decision.

For the first pass, the expected identifier is AX08-101 because the exercise explicitly establishes PR-08 revision 2 as authoritative. Both the description and document list should use it. The tool must not adopt AX08-100 merely because the working note was uploaded later.

The absent qualification information should remain visible as missing input for the agreed task. A plausible invented investigator history would fail the exercise. A generic warning elsewhere on the screen is insufficient if the delivered narrative still presents invented facts.

Next, introduce PR-08A and ask the writer to identify affected passages. The exercise now expects the new identifier after the authorized change is accepted. Inspect both output locations and the record explaining why they changed. Retaining a prior version is useful; the writer also needs to know which version is current.

Finally, introduce an undated note with a third identifier and no established authority. This time there is no defined precedence. The expected result is an unresolved source question for the designated owner, rather than an automatic choice. This checks whether the workflow handles uncertainty as well as straightforward corrections.

Follow a source link to the evidence it actually contains

A citation should help a reviewer verify a statement. Select a material assertion and ask a reviewer who did not prepare the draft to locate its supporting passage, confirm the source version and explain whether the passage supports the assertion.

Check for two different failures: the reference may point to the wrong location, or it may point to a relevant location that does not justify the wording. A file-level citation can be useful, but it may leave substantial search work when the source is long. Record that effort rather than treating all citation mechanisms as equivalent.

Include a qualification that changes how a fact should be read. Ask whether the draft preserves it and whether it remains understandable after export. The goal is usable evidence, not a high citation count.

Review scientific decisions separately from extracted facts

The workflow should make it clear when a writer is summarizing source content and when an expert is proposing an interpretation. Ask a reviewer to reject one proposed interpretation and explain the required revision.

Observe what happens to the original source references and the rest of the draft. The team should be able to distinguish a factual correction from a change in scientific interpretation and identify who accepted the revised text.

Leave one consequential review question unresolved. Inspect how the resulting document is labeled and handed off. A progress indicator must not imply that the content is accepted merely because a generation task finished or every requested heading contains text.

This exercise evaluates the support for your review process. It does not demonstrate that software can decide whether a particular development program has sufficient evidence for an IND.

Keep authoring and eCTD compatibility as separate gates

If the purchase includes publishing, specify the application's existing state and required eCTD version. FDA currently describes eCTD v4.0 acceptance for new regulatory applications and places forward compatibility for existing v3.2.2 applications in a future implementation phase. A demonstration using a new v4.0 application therefore does not establish support for maintaining an existing v3.2.2 lifecycle. FDA eCTD v4.0 implementation status.

Record the actual version and workflow demonstrated by the vendor. If the authoring output will go to another publisher, verify that recipient's required inputs and responsibility for technical checks. A useful drafting tool does not have to own publishing, but the combined arrangement must cover the handoff.

Ask the operator to identify what each validation result establishes. Technical checks and human content review answer different questions. The team's acceptance record should not turn a successful technical check into a claim of scientific adequacy or agency acceptance.

Apply the same exercise to the actual product configuration

For Assyro, begin with the authoring workflow and identify the exact IND sections, source handling and output being offered. Verify any publishing, authority or integration requirement separately. Do not infer native Word functionality or support for an existing legacy lifecycle from a general platform description.

Other vendors' descriptions can help you choose what to investigate. For example, Weave Bio Submission Builder describes drafting, source tracing, review and export, while INDAGO describes structured IND drafts, source links and review tools. Those statements justify scoped demonstrations; they are not evidence that either product has passed this checklist.

Use the same source packet and acceptance criteria for every configuration under consideration. Record custom setup, administrator intervention and unavailable functions. This article deliberately supplies the acceptance exercise rather than another broad vendor ranking.

Use Assyro’s regulatory-writing overview as a starting point for the demonstration, then verify every IND-specific requirement against the actual configuration.

Capture a decision the team can defend

This is an example of how to record a hypothetical failure, not a result attributed to a product. A meaningful record names the behavior and consequence. “Needs better AI” provides little direction for a purchase or remediation decision.

After the checks, separate suitable scope from remaining questions. A missing mandatory capability prevents acceptance for that use; an optional convenience can remain outside the purchase if the team agrees. Do not average away a failed must-have with strengths elsewhere.

Bring the completed record and representative sources to an Assyro evaluation discussion. The next step is a documented decision about the specific work your team needs to draft, review and hand off, supported by observations the responsible users can verify.