GCP Inspection Dossier template - Version 7.0 - Dossier requirements

Sep 4, 2026

GCP Inspection Dossier template for clinical trials involving Investigational Medicinal Products within the UK, to be submitted within 30 days of the advance notice email. The dossier supports inspectors in understanding organisational overview, defining inspection scope, and building the inspection plan. Submissions must be electronically provided in an easily navigable, searchable format (ideally a bookmarked PDF, with limited spreadsheet exceptions), include an electronic list of contents with page totals, and be limited to 100 pages. Section 1 requests organisation charts, clinical trial process lists (policies/SOPs/work instructions), and a computerised systems and validation status register.

LanguageEnglish

CategoryForms

FormatDOCX

Pages12

Reading Time4 min

AccessFree to download

General Requirements of GCP Inspection Dossier

Purpose and submission timeline

Electronic format and navigation requirements

Page limit and contents checklist

SECTION 1

Item 1: Organisation Charts

Item 2: List of clinical trial processes

Item 3: List of computer systems & validation status

Item 4: For non-commercial organisations only

GCP Inspection Dossier template The following information is requested specifically in relation to clinical trials undertaken (for Investigational Medicinal Products) within the UK and should be provided within 30 days of the advance notice email date. Note: the scope of the dossier request will be determined in the notification email you have received. If your organisation has been selected for a systems inspection, this dossier should be completed with all trial activities in scope. If you have been informed of our intention to conduct a trial specific inspection the dossier (and associated attachments) should be related to the selected trial(s) only. General Requirements of GCP Inspection Dossier The purpose of this dossier is to assist the inspector in developing an overview of your organisation prior to the inspection and to assist in defining the inspection scope and developing the inspection plan. The information should be submitted electronically to the GCP Inspection dossier mailbox ( HYPERLINK "mailto:GCP.Inspectiondossier@mhra.gov.uk" GCP.Inspectiondossier@mhra.gov.uk) The dossier should be in a format that is easy for the inspectors to navigate and search. Ideally it should be submitted as a bookmarked PDF document (with the exception of section 1 items 3 and 5, and section 2 item 3 which should be submitted as an excel spreadsheet). An electronic list of contents should be included that gives clear document references and the total number of pages for each section/item supplied (to enable an initial complete assessment on receipt, i.e., each page need not necessarily be numbered provided this assessment can be made). Please limit the electronic copy of the GCP Inspection Dossier to a maximum of 100 pages and ensure the information it contains is relevant to the planning of your inspection. A checklist is provided for you to review your GCP Inspection Dossier for completeness prior to submission to the MHRA. SECTION 1 Item 1: Organisation Charts (i) Please provide organisation charts relating to clinical trial activities with staff names and brief summaries of responsibilities (directly related to the activities in Section 2), if not obvious from department/function name. For organisations that are located globally, please only provide organisation charts for the UK operations and a top-level organisation chart for key functions outside the UK. OR (ii) For non-commercial organisations, please provide an organisation chart for the department responsible for research (e.g., the R&D department in Trusts) and a list of key contact points (i.e., those staff in involved in delivering processes) for support departments involved in clinical trials e.g., pharmacy, laboratories, imaging etc. The information supplied is used to assist the inspector in allocating resource to the inspection and to assist in compiling the inspection plan. Therefore if necessary, please provide a brief over-view (maximum 1-2 pages) of the clinical trial research structures. Where these are collaborative in nature, include an over-view of these (for example, University/Trust or Trust/Charitable Research Organisation collaborations). Please also reference any service level agreements, Memoranda of Understanding or similar referral arrangements which it may be necessary for the Inspectors to take into consideration. Please list areas where activities are undertaken jointly with another legal entity (for example, joint R&D office, clinical trial unit or statistics unit) and briefly describe with who the function is shared with and which organisation manages this area. Item 2: List of clinical trial processes Please provide a list of all your Policies/SOPs/Work Instructions and other documented procedures that cover the conduct of clinical trials in the UK. Please provide reference numbers, titles, issue numbers/dates. This information provides the inspector with an overview of your organisations quality system related to clinical trials. Please

FAQs

When must the GCP Inspection Dossier be submitted after the advance notice email?

The dossier must be provided within 30 days of the advance notice email date.

What format should the dossier be submitted in for inspector usability?

It should be submitted electronically in an easily navigable and searchable format, ideally as a bookmarked PDF, with specific exceptions where an Excel spreadsheet is required.

What types of information are required in Section 1, especially for computer systems?

Section 1 requires organisation charts, a list of clinical trial processes (policies/SOPs/work instructions with reference details), and a list of computer systems and their validation status, including system name, description, version history, reason for change, and who performed validation.

Sep 4, 2026

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