Continuing review and closing a Purdue Global study: what the board expects after approval
An approval letter is a datum, not a finish line. What it opens is a period during which the study must keep matching its own drawing, changes must be approved before they run, and — for some studies — the board looks again before its approval lapses. It ends not when data collection stops but when a closure is filed and recorded, and even that does not end everything: retention duties, confidentiality promises and commitments made to participants outlive the closure date. This sheet sets out what the board expects across that whole span.
Short answer
Some approved studies need continuing review before approval lapses; others do not, unless the board decides otherwise. All of them need changes approved first, problems reported, and a closure filed at the end. Retention and confidentiality duties continue past closure.
Does every approved study get a continuing review?
No, and the reason matters. Under 45 CFR 46.109(e), a board conducts continuing review of research requiring review by the convened board, at intervals appropriate to how much risk it carries. But 46.109(f)(1) removes that requirement — unless the board determines otherwise — for three situations: research eligible for expedited review; research the board handled under the limited review described in the exemption provisions; and research that has narrowed to analysis by itself, whether of identifiable private information or of identifiable biospecimens, or to the collection of follow-up clinical data from procedures participants would undergo as part of clinical care.
Read the exception carefully, because two words carry it. "Unless an IRB determines otherwise" leaves the decision with the board, and boards regularly do determine otherwise for particular categories. And "eligible for expedited review" describes the study's character, not the route it happened to take. Purdue Global's published pathways are human research determination, exemption and expedited review, so a great many of its studies sit inside the exception on paper. Whether the board has determined otherwise for yours is a question for the university's current handbook or IRB portal and for your own approval letter — which is the document that will say so if it applies.
So the honest answer to "when is my continuing review due" is: read your letter. An approval that names an expiry has told you. An approval that does not is telling you something as well, and the university's handbook is where that reading is confirmed rather than assumed.
What is expected of you while the study runs?
Three standing duties, none of which depends on whether continuing review applies.
- Run the study you had approved. The federal rule requires institutions to have procedures ensuring investigators run the activity on the terms the approval set, until proposed changes have been reviewed and approved — the single exception being a change needed to eliminate an apparent immediate hazard. Purdue Global's SOP 305 carries this through into its own amendment rule, and the sheet on modifications works out where the line falls.
- Report what the rule requires reporting. Boards must have procedures for prompt reporting of unanticipated problems involving risks to participants or others, and of serious or continuing noncompliance, to institutional officials and to the federal office. Your part of that machinery is telling the board, through the reporting instrument the university names, and telling it early.
- Keep the file accurate. Purdue Global's guidance repeats, in two separate documents, that updated materials must reach the board even where a change did not need prior approval. A study file that has drifted from the study is a finding waiting to be made.
It is also worth knowing what the board may do if those duties lapse. Under 45 CFR 46.113, a board has authority to suspend or terminate approval of research not being conducted in accordance with its requirements, or associated with unexpected serious harm to participants, and any such action carries a statement of reasons and is reported onward. That authority is rarely exercised against a well-run study; it exists to make the standing duties real.
What does closing a Purdue Global study actually involve?
Purdue Global publishes SOP 204, Protocol Closure, and it defines closure as a change in the status of an approved research activity from active to closed. For expedited studies the SOP places the reporting duty on the investigator. The board records investigator-initiated closures and administrative closures in its data management system, and the SOP applies to all human-subjects research it reviews, including exempt research.
Two consequences follow from the definition. First, closure is a filed act, not a state you drift into when the last interview finishes — an unclosed study remains open on the board's books regardless of what has stopped happening in the field. Second, the closure date is load-bearing: it starts the records-retention period the SOP sets, and the SOP notes that where other rules apply to a protocol, the longest applicable retention requirement governs, naming research covered by HIPAA as its example.
SOP 204 also ties the closure date for a project to the researcher's completion point in the program, which means the date may be determined by the calendar of the study's academic home rather than by the day you stopped collecting. Confirm how that is applied to your protocol through the university's current handbook or IRB portal before assuming either reading.
| Stage | What the board expects | The document that carries it |
|---|---|---|
| While active | Changes approved before they run; problems reported; study materials kept current in the file. | The modification form and the reporting instrument the university names. |
| If continuing review applies | A look at the study before approval lapses, at an interval set by how much risk it carries — where the board has determined that review is required. | The review instrument named in your approval letter or the current handbook. |
| At closure | Closure reported by the investigator for expedited studies, and recorded by the board as a change of status. | The closure route in the university's current portal. |
| After closure | Records retained for the applicable period; data kept only in the manner the approved protocol and consent allow; confidentiality protections honoured; commitments to participants kept. | SOP 204, and your own approved consent document. |
What survives the closure date?
More than most candidates expect, and this is the part of SOP 204 worth reading twice. Investigators must retain research records — the SOP names signed informed consent forms, the approved protocol and correspondence with the board among them — for the applicable retention period, in hard copy, electronic or other media, accessible for inspection and copying by authorised representatives of the board and of sponsors. The federal rule sets its own institutional retention floor at 45 CFR 46.115(b).
Once a protocol is closed, the SOP permits investigators to keep the data they collected, including identifiable private data, but only in a manner consistent with the approved protocol and with participants' consent, and confidentiality protections must continue to be honoured. That is a sentence with teeth: it means the promises made in your consent document govern the data after the study is over, and a plan to reuse a dataset later has to be checked against what participants were actually told.
And commitments survive. SOP 204 requires investigators to honour any other commitments agreed as part of the approved research — its examples are providing information about study results to participants, and honouring commitments for compensation. If your consent document promised a summary of findings, that promise closes with the study only when it is kept.
What most often goes wrong after approval?
- A change run first and filed later. The most common post-approval failure, and the one with no remedy — an amendment does not reach backwards over data already collected under an unapproved change.
- An approval allowed to lapse where continuing review did apply. Assumption is the whole failure here; the letter says which case you are in.
- Collection stopped, closure never filed. The study stays open, the retention clock never starts, and the record disagrees with reality.
- Data reused beyond what consent described. A closed study's data is still governed by what participants agreed to.
- A promised summary never sent. A small commitment, and the one participants actually remember being made.
How does this differ from the West Lafayette board?
Entirely, and this is worth stating plainly because search results mix them constantly. Purdue University Global is the online university for working adults; Purdue University in West Lafayette is a separate institution with its own board, its own standard operating procedures and its own portal. Procedures published by one do not govern research reviewed by the other. Everything on this sheet describes Purdue Global's published material and the federal rule behind it.
What to do next
Take out the approval letter and read it for three things: whether it names an expiry, what it says about reporting, and what conditions it attaches. Then check your consent document for every promise made to participants, because those are the obligations that outlive the study. If continuing review applies, calendar it against the letter rather than against your data-collection plan; the two are not the same schedule.
If you would rather hand the whole post-approval span over, that is what this practice carries — amendments, reports, continuing review where it applies, and the closure filed properly at the end. Ask for the free review, send the approval letter and the current file, and what comes back is a written list of the obligations it actually creates. How it works sets out the sequence; the FAQ handles the short questions.