GCP inspections
GCP inspections for clinical trials
Inspections carried out in connection with clinical trials may concern either good manufacturing practice for the manufacture of investigational medicinal products or good clinical practice (GCP) as regards the conduct of clinical trials.
The details of procedures for verifying good clinical practice are laid down in Commission Implementing Regulation 2017/556 (EUR-Lex).
GCP inspections for clinical trials as part of supervision
Fimea is responsible for the supervision of clinical trials in Finland and for compliance with EU and national laws in research work. According to the Clinical Trials Regulation, clinical trials must be conducted in line with the agreed trial protocol and with the principles of good clinical practice. For the purpose of supervision, Fimea may carry out GCP inspections pursuant to Article 78 of the Clinical Trial Regulation 536/2014.
GCP inspections may be carried out in the following situations (Article 2 of implementing regulation 2017/556):
a) before, during or after the conduct of a clinical trial;
b) as part of the verification of applications for marketing authorisation;
c) as a follow-up to the granting of marketing authorisations.
The annual plan for GCP inspections
Trials are selected for Fimea's annual GCP inspection plan based on the progress of trials initiated in Finland, questions related to marketing authorisation applications and other factors leading to a need for an inspection. The annual plan is therefore adapted and modified over time. The selection of medicinal products to be inspected is subject to a risk assessment in order to optimise the use of supervisory resources. Trial criteria used for the risk assessment relate to matters such as the stage of the trial, characteristics of the investigational product, trial participants (age, special populations) as well as any special aspects of the trial protocol.
The European Medicines Agency (EMA) coordinates the inspections carried out in the processing of centralised marketing authorisation applications (CAP), and the inspections may be carried out in either Member States or third countries. Inspections are normally carried out through cooperation between at least two Member States. Fimea's GCP inspectors participate in CAP inspections where resources allow.
Inspection types
An inspection may be either a routine inspection, the subject of which is selected according to predetermined criteria, or a triggered inspection arranged for a special reason.
The target of the inspection is the trial itself and may involve inspecting the activities of any party involved in carrying out the trial. The inspection may be carried out at the site where the subjects are treated (investigator site), the site of an organisation commissioned to be involved in the trial (Service Provider) or the site of the trial’s sponsor.
Currently, inspections can also be carried out remotely either in whole or in part.
Inspection procedure
Inspection planning and notification
Fimea's inspection team consists of a lead inspector, who serves as the primary contact between the inspectee and the agency, as well as other inspectors and experts. There may also be observers participating in the inspection.
The lead inspector contacts the contact person for the trial normally a few weeks before the planned inspection to notify them of the planned inspection date. The inspection can also be carried out without a prior notice. A written inspection announcement confirms the date and place of the inspection. This announcement contains a list of the material submitted to Fimea in advance. The members of the inspection team should also have (read-only) access to the electronic/computerized systems used in the trial, such as the case report forms and the trial master file.
If the inspection is carried out remotely either completely or in part, advance testing is arranged with the inspectee for both the needed video-conferencing systems as well as platforms used for the submission of documents (secure e-mail, electronic portal, etc.).
Inspection
At the inspection initial meeting the inspectors explain the objectives of the inspection and the detailed schedule (including interviews and visits to the study facilities) will be agreed upon. Inspections include interviewing trial personnel and examining trial-related documents (including patient records). The trial facilities and equipment are also inspected. Inspectors have the right to take visual recordings during the inspection.
During the inspection, a person must be available who can provide explanations to the inspectors and is familiar with the trial documents and records.
In the closing meeting, the inspectors share their findings. If any issues remain unresolved after the inspection and the inspector has not received satisfactory answers, the inspectee(s) may be requested to provide further clarification.
Access rights granted to the inspectors for electronic/computerized systems should not be revoked until the inspectors have confirmed that they are no longer needed.
Inspection report
The inspection team draw up an inspection report with a description of the observations and findings. Findings are classified as critical, major or minor depending on their impact on the safety, well-being and rights of the participants or the reliability of the trial data and results.
Once the inspection report has been signed at Fimea, the lead inspector sends a copy of the report to the sponsor, the agreed contact person and, in cases where the inspection has been carried out at the investigator site, the investigator as well. The inspectee has the opportunity to make a statement on the report. In this statement, the inspected party may raise matters for which corrections to the inspection report are requested. In addition, the inspectors may request further clarification from the inspectee concerning the findings identified in the report. If the findings are classiefied as serious or critical, the inspectee is requested to provide a root cause evaluation and a plan of corrective and preventive actions (CAPA plan).
Instructions for preparing an inspection response (fimea.fi).
Inspectee's statement and further clarifications, as well as inspection team's assessment thereof, are attached to the final inspection report. A copy of the assessment of the responses will be provided to the inspected party and the sponsor for their information.
Where several separate inspections are carried out on the same trial, a summary report may be drawn up summarising the findings of the separate inspections.
The GCP inspection is considered complete when the statement of the inspectee and any further clarifications have been assessed by Fimea.
The documents related to the inspection are archived in accordance with Fimea's filing plan (in a case management system).
Communication of inspection results and follow-up supervision
The results of GCP inspections are reported to the EU Clinical Trials Information System (CTIS). After the revision of CTIS transparency rules in June 2024, the inspection reports are no more made public.
Corrective and preventive measures must be taken in response to findings identified during inspections. Where necessary, Fimea may supervise their implementation through measures such as follow-up inspections.
If the inspection reveals serious or critical deficiencies that relate to participant safety or data reliability, Fimea may, where necessary, suspend the clinical trial or require the sponsor to amend the protocol. In case of applications for marketing authorisation, inspection findings may lead to further information requests or to rejection of the application. Fimea officials carry out any further measures in line with the organisation’s rules of procedure.
7.8.2026 text updated according to ICH E6(R3) terminology, added info that inspectors' access rights should not be revoked until notified, minor text corrections aligned with the Finnish web page
Ask more
Sarianne Päivike, senior inspector, tel. +358 29 522 3233
Anne Timonen, senior inspector, tel. 358 29 522 3375
E-mail addresses follow the form [email protected]