clinicalprecedent.comClinical investigator vet report
A. Okafor, MD fictional
A. Okafor, MD fictional
Springfield, Illinois · FEI 0000000001
fictional · Clinical Investigator (CI) ·
Northgate Clinical Research Associates fictional
No name matches on FDA’s clinical investigator disqualification or debarment lists.
Status-list checks
| FDA list | Result |
|---|---|
| Disqualification proceedings (NIDPOE / NOOH) | Checked — no name match. |
| Debarment list (FD&C Act §306) | Checked — no name match. |
| Pre-2009 CDER and CBER clinical-investigator inspection lists | Checked — no name match. |
4
FDA inspections
1
serious (OAI)
1
voluntary action (VAI)
2
no action (NAI)
6
findings cited
1
warning letters
How this record compares
Share of this site’s 4 inspections ending in each classification, next to the share across all drug and biologic inspections in the FDA dataset. Context, not a verdict.
Inspection history (4)
| Ended | Classification | Program | Findings |
|---|---|---|---|
| 2024-11-19 | NAI | Clinical investigator | — |
| 2023-05-02 | OAI | Clinical investigator | 4 findings |
| 2020-09-15 | VAI | Clinical investigator | 2 findings |
| 2017-03-08 | NAI | Clinical investigator | — |
OAI is the most serious inspection classification FDA assigns. Often it leads eventually to a warning letter.
Findings by problem area (6)
| Regulation | What was cited | Inspections |
|---|---|---|
| 21 CFR 312.60 | Obtaining Informed Consent — Failure to obtain informed consent in accordance with 21 CFR Part 50 from each human subject prior to conducting study-related tests. | 2 |
| 21 CFR 312.60 | Conducting the Study — An investigation was not conducted in accordance with the signed statement of investigator and investigational plan. | 2 |
| 21 CFR 312.62(b) | Case Histories — Failure to prepare or maintain adequate and accurate case histories with respect to observations and data pertinent to the investigation. | 1 |
| 21 CFR 312.61 | Control of the Investigational Drug — A study drug was provided to persons not under the investigator’s personal supervision or under the supervision of a subinvestigator responsible to the investigator. | 1 |
Warning letters (1)
| Date | Action | Center | Warning letter |
|---|---|---|---|
| 2024-03-14 | Warning Letter | CDER | Full text in Appendix B fictional |
Next steps a sponsor can take: asking the site for their responses and corrective action plans, visiting the site before signing, or choosing a site without this history. The report documents the record; the decision is yours.
Appendix A — Findings detail and Appendix B —
Warning letter text follow in a real report, so the exported PDF stands alone in a
quality file. They are omitted from this sample.
Methodology. This report is a point-in-time snapshot of
the publicly available FDA Bioresearch Monitoring (BIMO) record for the subject named
above. Inspections, findings and warning letters are matched by exact legal name or FEI
number as recorded by FDA; FDA spells names inconsistently, so a no-match result should
be re-run under known name variants or the FEI number if known. Disqualification, debarment and pre-2009 CDER and CBER
inspection lists carry names only, so those checks match on the
parts of the name and are labeled “name match” — identity must be confirmed before
relying on a match. Scope is drug and biologic clinical research; records outside that
scope are noted but not shown. This report documents the record; it does not make
recommendations or provide regulatory advice.
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· fictional sample