GCP Inspection Report - Procedure Reporting GCP Inspections Requested - CHMP GCP Inspection Report

Sep 13, 2026

GCP Inspection Report template for documenting a Good Clinical Practice inspection at a specified site, issued on behalf of the European Medicines Agency. The report captures administrative information, inspection background, and grading of findings, then details operational resources including organization, personnel, facilities, equipment, and computer systems. It outlines trial administrative aspects, trial master file expectations, clinical conduct, sponsor/CRO trial management, safety reporting, investigational medicinal product handling, clinical data management, source data review, monitoring, diagnostics, sample and laboratory activities, bioanalysis, pharmacokinetic and statistical analysis, and the required report deliverables.

LanguageEnglish

CategoryLetters

FormatPDF

Pages26

Reading Time9 min

AccessFree to download

Administrative information

Background and general information

Reason and cause for the inspection

Reference texts

Grading of findings

List of persons involved in the trial and contacted during the inspection

Operational resources

Organisation

Personnel

Qualifications and training

Facilities

Equipment

Computer systems

Administrative aspects of the trial

National competent authority

Independent research ethics committee (IEC)

Other committees, any other validation or authorisations required

Contract(s) and agreement(s)

Insurance

Trial master file

Production, version control and content of essential documents

Completeness, availability, content and structure of TMF/ISF

Clinical conduct of the trial

Management of the trial by sponsor/CRO

Safety reporting

Investigational medicinal product(s) (IMPs)/pharmacy

Clinical data management

Source data review/verification

Clinical trial monitoring

Instrument-based diagnostics/ examinations

Clinical sample management

Clinical samples (at investigator site)

Clinical samples (at laboratory or analytical site)

Laboratory

Bioanalysis (PK) laboratory

Methods used

Method validation and report

Results

Pharmacokinetic analysis

Statistical analysis

Reports

Clinical study report

GCP Inspection Report XXX at XXX site On behalf of the European Medicines Agency XXX Inspector in charge of this inspection report Name: Position: Address: Tel: E-mail: XXX XXX XXX Inspection report date: DD-MM-YYYY Responses to inspection report: Dated as per Addendum 1 Evaluation of inspection responses: Dated as per Addendum 2 This inspection report may only be reproduced in its entirety and must not be circulated or published without the European Medicines Agency’s consent, nor may any additions be made to the report. Table of contents 1. Administrative information ................................................................................................ 5 2. Background and general information ................................................................................. 6 2.1. Reason and cause for the inspection .................................................................................... 6 2.2. Reference texts ................................................................................................................ 6 2.3. Grading of findings ........................................................................................................... 6 2.4. List of persons involved in the trial and contacted during the inspection ................................... 7 3. Operational resources ........................................................................................................ 8 3.1. Organisation .................................................................................................................... 8 3.2. Personnel ........................................................................................................................ 8 3.3. Qualifications and training ................................................................................................. 8 3.4. Facilities ......................................................................................................................... 8 3.5. Equipment....................................................................................................................... 8 3.6. Computer systems ............................................................................................................ 8 4. Administrative aspects of the trial ..................................................................................... 8 4.1. National competent authority ............................................................................................. 8 4.2. Independent research ethics committee (IEC) ...................................................................... 8 4.3. Other committees, any other validation or authorisations required........................................... 8 4.4. Contract(s) and agreement(s) ............................................................................................ 8 4.5. Insurance ........................................................................................................................ 8 5. Trial master file.................................................................................................................. 9 5.1. Production, version control and content of essential documents ............................................... 9 5.2. Completeness, availability, content and structure of TMF/ISF .................................................. 9 6. Clinical conduct of the trial ................................................................................................ 9 7. Management of the trial by sponsor/CRO .......................................................................... 9 8. Safety reporting ................................................................................................................. 9 9. Investigational medicinal product(s) (IMPs)/pharmacy .................................................... 9 10. Clinical data mana

FAQs

What administrative details are required at the start of the GCP inspection report?

The report requires inspector identity and contact information, the inspection report date, and information about responses and their evaluation dates as referenced by addenda.

Which topics are covered under operational resources during the inspection documentation?

It includes organization, personnel, qualifications and training, facilities, equipment, and computer systems.

How does the report structure address trial files, safety, and data processes?

It specifies Trial Master File requirements, outlines safety reporting, and covers clinical data management and source data review/verification, followed by monitoring and related activities.

Sep 13, 2026

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