Preparation and Conduct During Inspections
Part of Good Clinical Practice (GCP) — ICH E6(R3): Audits, Inspections and Compliance.
About 6 minutes. Free, in your language, no account needed.
Why this matters
Most inspection findings are not caused by bad science. They are caused by records that were never written, or written late, or written twice with different content. An inspection does not create these problems. It reveals them. A site that prepares only when an inspection is announced will be found out, because the preparation itself leaves traces.
What an inspection is, and where it happens
ICH E6(R3) is the current revision of the Good Clinical Practice (GCP) guideline. Its Glossary defines an inspection as the act by a regulatory authority of conducting an official review of documents, facilities, records and any other resources deemed related to the clinical trial.
Two points matter for planning.
First, the location is broad. An inspection may take place at the investigator site, at the sponsor's or a service provider's facilities, including a contract research organization (CRO), or at other establishments the authority considers appropriate.
Second, and newer in emphasis: "Some aspects of the inspection may be conducted remotely." The Glossary definition of Direct Access agrees. Direct access is "Permission to examine, analyze and verify records that are important to the evaluation of a clinical trial and may be performed on-site or remotely." So an inspector may review your electronic site file or your audit trails without entering the building. Remote review is still inspection.
Direct access is not a courtesy you grant on the day. Section 3.16.4(a) requires the sponsor to ensure the protocol or another documented agreement specifies that the investigator provides direct access to source records for monitoring, audits, regulatory inspection and, where applicable, IRB/IEC review. Section 3.16.4(b) requires the sponsor to ensure participants have consented to that direct access.
Preparing before anything is announced
Preparation is continuous, not an event. Work through these areas.
- Essential records — the site repository is complete and current. Appendix C.2.6 requires records to remain complete, readable and readily available, and directly accessible on request by regulatory authorities, monitors and auditors.
- Delegation — the record of persons to whom the investigator delegated trial-related activities is current, and no one performed an activity before delegation.
- Training — evidence that staff were trained for what they actually did, including after protocol amendments.
- Informed consent — correct version used each time, signed and dated by the participant and by the person who conducted the discussion, and the process documented in source.
- Data — entries made, queries resolved, corrections traceable, no unexplained gaps between source and the data acquisition tools.
- Investigational product — accountability records reconcile, storage conditions documented, excursions reported and dispositioned.
- Safety — serious adverse events reported to the sponsor immediately after the investigator became aware, with causality assessed and follow-up documented.
A useful habit is the mock inspection. An internal reviewer who did not do the work walks the file and writes down what could not be answered within a few minutes. Anything that took too long to find is a real finding, even if the record existed.
During the inspection
Behavior during the inspection changes outcomes as much as the records do. The rules below are short because they need to be remembered under pressure.
| Do | Do NOT |
|---|---|
| Be honest. | Create missing documentation on the spot. |
| Provide only requested documents. | Guess or speculate. |
| Ensure the principal investigator is available. | Provide unrequested documents. |
| Answer clearly and succinctly. | Edit source documents during inspection. |
| Document the inspector's questions. | Argue with a finding in the moment. |
Three of these deserve explanation.
"Do NOT create missing documentation on the spot" is the most serious rule on the list. A record written today about an event last year is not contemporaneous. If it is presented as one, that is a data integrity finding, and a graver one than the original gap. If a record is missing, say it is missing.
"Do NOT edit source documents during inspection" follows the same logic. Corrections must be traceable and must not obscure the original entry. Correcting a source record while an inspector reviews it destroys the traceability the inspector is testing.
"Provide only requested documents" protects both sides. Extra documents open lines of inquiry outside the scope, and they divert the site from the actual request.
Assign a scribe. One person records every question, every document handed over and every answer given.
Common findings
The same findings recur across sites and across regions:
- Insufficient investigator oversight — no evidence the investigator reviewed data, safety or delegation.
- Protocol noncompliance — ineligible participants enrolled, assessments missed, visits outside windows.
- Informed consent problems — an outdated form used, missing dates, procedures performed before consent.
- Documentation problems — illegible entries, retrospective entries, corrections that obscure the original.
- Investigational product accountability — logs that do not reconcile with physical count.
- Incomplete adverse event assessment — events recorded but never assessed for causality or followed up.
Each is preventable by a routine that runs every week.
In practice
A regulatory authority notifies Dr. Sarah's hypertension site of an inspection in fourteen days. Part of it will be remote: the inspector requests read-only access to the electronic site file in advance.
The coordinator, Amina, runs a mock inspection and finds three problems. A sub-investigator signed eligibility checklists for four participants before his delegation date. Two temperature excursion reports have no documented sponsor disposition. A screening log has a five-week gap.
Amina does not backdate the delegation record. She documents the finding, notifies the sponsor, and prepares a factual explanation with the dates as they actually are. The missing dispositions are available from the sponsor, so she requests copies and files them with the date received. The screening log gap turns out to be a period when no one was screened, so she adds a dated note saying so.
On the day, the inspector asks why the sub-investigator signed early. Dr. Sarah answers directly, states the corrective action taken, and does not speculate about intent. The finding stands, but the site's credibility does not fall with it.
Honesty costs one finding. A fabricated record costs the trial.
Key takeaways
- Under the ICH E6(R3) Glossary, an inspection is an official review by a regulatory authority, and some aspects of an inspection may be conducted remotely.
- Direct access under the ICH E6(R3) Glossary may be performed on-site or remotely, and section 3.16.4 requires it to be specified in the protocol or another documented agreement and consented to by participants.
- Appendix C.2.6 requires essential records to remain complete, readable, readily available and directly accessible on request by regulatory authorities, monitors and auditors.
- During an inspection you should be honest, provide only requested documents, keep the investigator available, answer succinctly and log the inspector's questions.
- You must never create missing documentation on the spot, guess or speculate, provide unrequested documents, or edit source documents during an inspection.
- A mock inspection run by someone who did not do the work converts hidden gaps into fixable findings before a regulator sees them.