Template Integrated Inspection Report on behalf of the European Medicines Agency
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[Insert CA logo here in the header below EMA logo (aligned right)] GCP Integrated Inspection Report[insert EMA inspection reference number] On behalf of the European Medicines Agency XXX [Insert name of the competent authority of the reporting inspector]
XXX [Amend to EMA application reference number]
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 5 2.1. Reason for and scope of the inspection 5 2.2. Reference texts 5 2.3. GCP inspection finding grading 6 3. Description of GCP inspection findings and responses 8 3.1. Foreword 8 3.2. Number of inspection findings 8 3.3. Summary of inspection findings and evaluation by the inspectors of the response from inspectee(s) 8 4. Conclusions from inspection findings 8 4.1. Assessment of the relevance of the findings for the full study 8 4.2. Quality of the data, ethical conduct and GCP compliance 8 4.3. Recommendation for the acceptability of the clinical trial data for the submitted application assessment 8 4.4. Recommendation for follow up actions (GCP systems) 8
Abbreviations [Review and amend list as necessary]
* RI= reporting inspector; LI= lead inspector, I= inspector; E= expert; O= observer
Type here [Insert reason(s) for the inspection(s), i.e. by EMA as part of a centralised procedure. Please give the date of the request. Please give a short description of the scope of the inspections. This information should be from the inspection request and pre-inspection discussions with assessors.]
[Review the following list and amend as necessary and consider the versions valid during the conduct of clinical trial and insert any local law(s) and regulations.]
Inspection reports for the sites inspected are contained in the appendices. These reports contain full details of the inspections, the findings and the responses and the inspector evaluation of the responses. This report is to provide an overview of the findings from the inspections. For more detail refer to the individual inspection report(s).
[For each inspection state the number of critical, major and minor findings.] At the inspection of [site name] there were [number of] critical, [number of] major and [number of] minor findings.
Type here [This should provide a summary of the key findings relating to that particular subject area and summarised across the inspection reports – for example, the same issue could occur at all the investigator sites. The findings should NOT just be cut and paste from the inspection reports as these are already in the Appendix. They should be reviewed and summarised (e.g. evidence need not be cited, just the issue). If the assessors needs the detail, they can look at the inspection report, so references to the inspection report and finding number from that report should be added (as shown in the example below). It may be useful to break the summaries into different areas as would be evident from the findings in the inspection reports themselves. This section of the report should be CONCISE AND TO THE POINT as the detail is in the Appendices and it is the evaluation later that is important for the IIR Summarise information from the inspection reports about how the response from the inspectee and/or sponsor changed the inspection outcome (e.g. were findings downgraded or disputed such that were no longer applicable, were any actions taken at all, was a response provided at all). The responses should be contained as Appendices to the inspection reports that are appended to the IIR – these can be referenced if necessary.] [EXAMPLE:- 3.3.1 Management of Investigational Medicinal Products There were major findings in relation to full and complete documentation being available to fully reconstruct the IMP shipments and undertake full accountability. In addition, at the inspections, it was not possible to verify that appropriate storage conditions for the IMP had been maintained during shipment such that its integrity had not been compromised, nor had the sponsor provided this information to the site to enable them to confirm the shipment conditions. The sponsor was asked to provide documentary evidence to confirm appropriate shipping conditions in response to the finding. This was provided and the confirmed shipping conditions were acceptable. Inspection Site 1: Major findings 17 and Minor findings 18; Inspection Site 2: Minor findings 12 and Inspection Site 3: Minor findings 13.]
Type here [Discuss if the findings are process related and not site specific and thus relevant for the overall clinical trial or clinical development programme.]
Type here [Discuss the implication of any major or critical findings on data quality {cross reference to section 3.3 or the IRs} and compliance with the GCP principles and ethical standards. This section may need to be specific on which data were affected and to what extent. The section may need to discuss the results of any responses by the inspectee/sponsor that are re analyses (extrapolations/ sensitivity).] [Statement on GCP compliance and whether the trial was conducted in accordance with internationally accepted ethical standards, describe the areas where deviations from full GCP-compliance were detected if applicable, and to what extent GCP compliance is impaired.]
Type here [Provide a conclusion on whether the quality of the data inspected as a whole or in parts may be used for the evaluation by the assessors regarding acceptance/ non-acceptance of the trial data of the current marketing authorisation application] [Include discussion of responses and commitments to provide further documents or actions that address the inspection findings that are needed for the assessment procedure to continue, e.g. additional analysis, new CSR or CSR addendum, etc.] [Consider if inspection findings are likely to influence/ may influence/ are less likely to influence the benefit-risk evaluation, for example by their impact on validity/ reliability of data (specify trial data which are affected by findings or overall trial data as appropriate).]
Type here [Provide any recommendations in case a re-inspection is deemed necessary in respect of any GCP system findings, for example, must inspect further MAA applications involving inspected organisations, or recommend further national inspections/follow up etc.]
[Add further set of rows as required or delete if less than 3]
Inspection report 1 Inspection report 2 [Add others as required on this page – then you can just append the full pdf reports without needing any separators in this Word document. Count the total pages that you have added as pdf documents and add 1, then put total in footer.] [NOTE: Associated documents (e.g. response of the inspectee/ sponsor, evaluation of the response, etc.) should already be appendices/ addenda of the appended inspection report, so there should be one pdf report available with it all in – i.e. with all appendices and addenda. 30 Churchill Place ● Canary Wharf ● London E14 5EU ● United Kingdom An agency of the European Union
+44 (0)20 3660 6000 Facsimile +44 (0)20 3660 5555 info@ema.europa.eu Website www.ema.europa.eu © European Medicines Agency, Yüklə 72,71 Kb. Dostları ilə paylaş:
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