An IRB return is a tolerance failure.

The board reads one study across four documents — proposal, application, consent, site letter. Where the proposal says twelve and the consent says fifteen, the file comes back: not because the study is unsound, but because the drawing of it disagrees with itself. We are independent consultants and we handle the entire Purdue Global IRB process end to end — the determination, every document, the submission, every reply to the board — every week. The study stays yours; the first measure is free.

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Plate data

The practice's record on Purdue Global files — files read every week.

1,400+ IRB application files prepared
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One study, measured four times

Every number in your study is a dimension, and every document that repeats it is a second measurement of the same feature. Sample size, instrument names, site count, recruitment wording — the reviewer reads each of them in the proposal, then in the application form, then in the consent, then in the site letter. Agreement is invisible. Drift is a finding. Below: one dimension — the sample — read across all four.

tolerance: identical in every document Δn = 0 · in tolerance Proposal n = 12 method chapter Application n = 12 the form's sample item Consent n = 12 the invitation sentence Site letter n = 12 on letterhead reads 15 here — three documents read 12 the protocol of record — every document measures from it
Fig. 1 — The sample dimension, read across the four documents the board reads together. Toggle the state above the drawing.

Four documents, one number. The reviewer has nothing to ask, so the reviewer moves on.

Where files drift out of tolerance

Six dimensions account for most returns, and none of them is about the quality of the study. Each is a place where the file can disagree with itself — or with what a board requires a file to state plainly. Each is measurable before you submit.

Fig. 2
current on the day it is read the module set the handbook names

Training current, and in the right modules

The certificate is read before the study is — CITI or whatever ethics training the university's current handbook names. Two measurements: is it current on the day the file is read, and is it the module set required for your role and your design — human-subjects, social-behavioral, whichever applies. A lapsed certificate, or the wrong module set, stops the review at the cover sheet, before a single idea of yours has been considered.

Fig. 3
purpose & procedures risks & benefits confidentiality limits decline or withdraw whom to contact version = the protocol's version

Consent that carries every required element, version-matched

A consent form is enumerable: purpose, procedures, risks, benefits, the limits of confidentiality, the right to decline or withdraw without consequence, whom to contact. Miss one element and the return names it. And the consent in the packet must be the version the protocol cites — an old consent stapled to a revised protocol is the drift boards find most often, because it is the one they are trained to measure first.

Fig. 4
as approved as it runs = word for word — the artifact itself

Recruitment materials exactly as they will run

The board approves the flyer, the email, the forum post — the artifact itself, word for word, not a description of it. "We'll finalize the wording later" is not a submission the board can act on; and running wording the board never saw is a deviation, not a shortcut. Draw the recruitment piece as it will actually appear, submit that drawing, and then run only that drawing.

Fig. 5
the site's letterhead — signed with authority names the records, the people, the minutes

A site letter that names the actual data

"Happy to support this study" is goodwill, not permission. The letter a board can accept sits on the site's letterhead, is signed by someone with the authority to grant access, and names what will actually be collected — which records reviewed, which people interviewed, how many minutes observed. If the letter and the application describe different data, that is one dimension measured two ways, and the file comes back to have it reconciled.

Fig. 6
four answers, each with a name in it stored opened de-identified destroyed "kept secure" is the sentence that comes back

Data-security answers that name things

Where it is stored — which encrypted service, not "a laptop." Who can open it — named roles, not "the research team." When identifiers come off, and where the key linking codes to names is kept. When and how it is destroyed. Four questions, four nameable answers. "Data will be kept secure" is the one sentence reviewers are trained to send back, because it measures nothing.

Fig. 7
the box you tick must match the drawing QI — improves this place research — travels

A category claimed honestly

Quality improvement measures a local process to improve it in place; research produces knowledge meant to travel. The category you claim must match the design you drew — a comparison group, an instrument you validate, a plan to publish generalizable findings will contradict a QI claim, and the reviewer reads the design, not the tick-box. The same honesty governs exempt versus expedited. Claim the study you actually drew, and the category question becomes the easiest one on the form.

The approval datum

Every drawing measures from a datum. In human research the datum is the approval letter: the day the board's letter exists, data may begin to exist — not the day you feel ready, not the day the site says yes. Anything collected left of the datum is not data the study can use, and no amendment repairs it, because approval does not reach backwards. The same edge governs change: a new site, a reworded flyer, a revised instrument moves through amendment before it runs, or the study is operating outside its own approval. It is the one dimension with no tolerance at all — and the cheapest to hold, because holding it costs only patience.

before the letter: no data may exist here the study's life day zero — the approval letter exists collected early — invalid, and no amendment reaches backwards data may exist — exactly as approved a change to the drawing? amend first, then run
Fig. 8 — The datum has no tolerance. Data collected before it exists cannot be made valid afterwards.

The tolerance check

Five dimensions, measured from memory — answer with the documents closed. The point is whether the file agrees with itself when you are not looking at it. "Not sure" is a legitimate reading; it is also a finding.

0 of 5 dimensions measured

1Does your sample number read identically in the proposal, the application and the consent form?

2Are your instruments named with exactly the same words everywhere they appear?

3Does the site letter name the actual data you will collect — not just "support for the study"?

4Is the consent version stamped to the current protocol — the packet's consent is the protocol's consent?

5Does your category claim — QI or research, exempt or expedited — match the design as you actually drew it?

Nothing here is recorded — the reading is yours.

The free review is the first measure. We carry the rest of the plate.

We are an independent consulting practice, and the IRB process is our weekly work — for doctoral candidates and professionals in Purdue Global's programs who would rather not learn a board's language under deadline. When you want it handled, we handle the entire process, end to end. The study, the data and the findings remain yours; the board's decision is its own. Everything between those two truths is ours to draw and carry, in three moves.

  1. 1

    The determination and the plan

    We read the design as you drew it and settle the category honestly — not human-subjects research, quality improvement, exempt, expedited, full board — then lay out the plan: which documents the board will read, which dimensions must agree across them, what the site must sign, and that your training certificate is current and in the right modules before anything goes in.

  2. 2

    Every document, drawn to the same dimensions

    The application itself, the consent with every required element and the right version on it, the recruitment materials exactly as they will run, the instruments named once and everywhere, the data-security plan with a name in every answer, the site permission letters drafted for signature — each prepared to the same dimensions, so the file cannot disagree with itself.

  3. 3

    Submitted, and every reply answered until approval

    We assemble and submit the file, and when the board writes back we answer it — revision responses, amendments whenever the drawing changes, continuing review when the board calls for it — until the approval letter exists and the datum is set.

And when a file measures clean at the first review, we say so — one line: submit it. A practice that always finds something is a sales letter with calipers. Ours is not. Send whatever exists — a finished packet, or a proposal and three half-drafts; the review returns a written findings list, and from there you take the plate, or we do.

a drift — the same dimension reading two ways a missing element, named clean — submit it
Fig. 9 — Key to the marks the first review returns. The third mark is the one we hope to use.

The drafting room

Three consultants draw and carry every Purdue Global file that leaves this practice. Each owns a set of dimensions, and every file passes all three before it goes to the board.

Victoria Halloran
PhD
Lead consultant — tolerances and determinations

Victoria reads the design first and settles what it is — not human-subjects research, quality improvement, exempt, expedited, full board — before a single form is opened. Every file that leaves the room passes her tolerance reading: the same dimension, identical in every document.

Grace Whitaker
DNP, APRN
Consent, instruments and data-security

Grace draws the consent with every required element and the right version on it, names each instrument once and uses those words everywhere, and writes data-security answers with a name in them. Hers are the pages reviewers stop finding things in.

Nora Castellano
MSN, RN
Site letters, submissions and board replies

Nora drafts the site permission letters for signature so they name the data, assembles and submits the file, and answers the board when it writes back — revision responses, amendments, and the continuing review — until the approval letter exists.

Measured, in their words

Four readings from candidates whose files we drew or carried. Names are shortened at their request; the outcomes are theirs.

Allison K., DNP candidate

Returned once, then approved

My consent said fifteen and my application said twelve, and I had read both a dozen times without seeing it. They found it in the first review, fixed the drawing everywhere it appeared, and the resubmission came back approved with nothing else flagged.

Marcus T., PhD candidate

Approved on first submission

My site letter said "happy to support." Nora rewrote it so the site named the records I would actually pull, got it signed on letterhead, and the board never asked a question about access. First submission, approved.

Danielle R., DNP candidate

Quality-improvement determination

I was certain my project was research. Victoria read the design, showed me it was quality improvement, measured the claim against what I had actually drawn, and the determination came through without a revision. I would have filed the wrong form and waited for nothing.

Jennifer M., PhD candidate

Amendment after approval

Halfway through collection I needed a second site. They drew the amendment, matched every document to the new site count, and handled the board's reply. The first site never stopped, and the second started on the right side of the datum. My only regret is not sending them the proposal earlier.

What it costs

Every package is quoted after the first measure, so the price fits the plate, not a menu.

Determination & Plan

The first move, on its own

For the candidate who will draw the file but wants the category settled and the plan laid before a form is opened.

  • The design read as drawn; the category settled honestly
  • The document plan: what the board reads, which dimensions must agree
  • What the site must sign; what your training must show
  • A written plan you can file against

Quoted in writing after the free review. Fixed fee, nothing by the hour.

Start with the free review

The Complete File

Every document, drawn to the same dimensions

Determination and plan, then the whole packet prepared so it cannot disagree with itself. You submit it.

  • Everything in Determination & Plan
  • Application; consent with every element and the right version
  • Recruitment materials as they will run; instruments named once
  • Data-security plan with a name in every answer
  • Site permission letters drafted for signature

Quoted in writing after the free review. Fixed fee, nothing by the hour.

Start with the free review

Full Handover

Most chosen — the entire process, end to end

The complete file, then the submission itself and every reply to the board until the approval letter exists. You keep the study; we carry the plate.

  • Everything in The Complete File
  • The submission, assembled and filed
  • Revision responses, amendments, continuing review
  • Carried until the approval letter exists

Quoted in writing after the free review. Fixed fee, nothing by the hour.

Start with the free review

Questions, answered first

Nine questions candidates ask before they send anything. Each answer is in its first sentence; the rest is the reasoning. Where a detail is the university's to set, the answer says so and points to Purdue Global's current handbook or IRB portal, which governs where this sheet and it differ.

Is this about Purdue Global or Purdue University in West Lafayette?

Purdue University Global — the online university built for working adults — and the IRB process its doctoral studies and capstones pass through; not Purdue University in West Lafayette, Indiana, which is a separate institution with a separate board and separate procedures.

The two share a name and a system and almost nothing else that matters to a human-research file: forms, portals, training requirements and review cycles are set separately, so guidance for one does not transfer to the other. Everything on this site concerns Purdue Global.

Does a Purdue Global capstone or doctoral study need IRB review before collecting data?

If the project collects data from or about living people — surveys, interviews, observations, records with identifiers — a determination from the university's IRB must exist before any of that data does, and Purdue Global's current handbook or IRB portal sets exactly what is filed and when.

The determination may be that the project is not human-subjects research, or quality improvement, or exempt, or expedited, or full board — but that reading is the board's to make, before collection and not after. Assume a file is required and let the determination settle how much of one.

Why do IRB applications come back?

Most returns are tolerance failures: the same dimension — the sample number, an instrument's name, the site count, the recruitment wording — read in two documents and found different, or a required element the board needs stated plainly and the file does not state.

The board reads one study across several documents, and agreement between them is invisible while drift is a finding. "Twelve" in the method chapter and "fifteen" in the consent is the classic return; so is a consent from a superseded protocol version, a site letter describing different data from the application, and a data-security plan that names nothing. None of these is a judgement on the study. All are measurable before submission — Figures 1 to 7 above draw them.

Can I collect any data before the approval letter?

No. The approval letter is the datum: the day it exists, data may begin to exist, and anything collected before it is not data the study can use — no amendment reaches backwards to make it valid.

The same edge governs change after approval: a new site, a reworded flyer, a revised instrument moves through amendment before it runs. It is the one dimension with no tolerance at all, and the cheapest to hold, because holding it costs only patience.

Do I need CITI training?

You need the human-research ethics training the university's current handbook names — CITI is the usual program — current on the day the file is read, and in the module set required for your role and your design; the certificate is read before the study is.

Two measurements, not one: currency and module set. A lapsed certificate, or the wrong modules, stops the review at the cover sheet. Which modules and how long a certificate is honoured are the university's to set; check the handbook and, if anything has changed since you trained, retake before you file.

Do I need a site permission letter?

If any data is collected at, from or about an organisation you do not control, yes: a letter on the site's letterhead, signed by someone with the authority to grant access, that names the actual data — which records reviewed, which people interviewed, how many minutes observed — and agrees with the application.

"Happy to support this study" is goodwill, not permission, and a board cannot act on it. If the letter and the application describe different data, that is one dimension measured two ways and the file comes back to have it reconciled.

Exempt, expedited, full board — what is the difference?

Three levels of review for human-subjects research, set by the federal Common Rule and applied by the university's board: exempt for minimal-risk research in defined categories, expedited for minimal-risk research outside them, full board for anything above minimal risk or involving vulnerable populations — and the board, not the applicant, decides which applies.

Exempt does not mean "no file"; it means a shorter determination the board still makes. Claim the level your design actually supports — a comparison group, a vulnerable population, sensitive identifiable data will contradict an exempt claim, and the reviewer reads the design, not the tick-box. The university's handbook names its own categories and forms for each path.

What happens when the board returns my application?

The return letter names findings; you answer each one on the record, fix the drawing everywhere the finding appears — not only the sentence the board quoted — and resubmit through the university's portal; a return is a question the file could have answered, not a verdict on the study.

If the board found "twelve" against "fifteen", the response changes every document that carries the number and says so. A response that fixes one place and leaves another creates the next return. In Full Handover we draw the response and answer every reply after it until the approval letter exists.

Do you conduct my research, and what does it cost?

We do not conduct the research — the study, the data and the findings stay yours — but we handle the entire IRB process end to end if you want it handled, and the cost is quoted in writing after the free application review, as a fixed fee for one of three packages: Determination & Plan, The Complete File, or Full Handover, the premium, which carries every document, the submission and every reply until the approval letter exists.

No prices appear on the site because an honest figure does not exist before the file is read; nothing is billed by the hour and nothing is added afterwards. The free review may also return one line — submit it — with no quote at all. The pricing sheet sets out the three packages; how it works sets out the three moves they carry.

Six more — quality improvement or research, what goes in a complete file, the consent elements, the data-security plan, amendments, and whether anyone can promise an outcome — are on the full questions sheet.

Give us the entire IRB process. Keep the study.

The free application review is where it starts. From there we carry everything — the determination and the plan, every document drawn to the same dimensions, the submission itself, and every reply to the board until the approval letter exists. The study, the data and the findings remain yours; the board's decision is its own. The plate between those two truths is ours to draw and carry.

Request the free application review Send whatever exists — drafts count.
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