Inspection of clinical trials

The investigator must have documented training in GCP.

The Swedish Medical Products Agency (Swedish MPA) carries out GCP inspections to confirm that:

• the rights and well-being of persons involved in clinical trials are safeguarded;
• recorded and reported data are obtained in a scientifically accurate manner and that adequate systems and procedures are in place to ensure that the trial is conducted and data is recorded in accordance with ICH GCP;
• requirements and procedures are followed in accordance with the applicable regulatory framework and quality standards and approved trial protocol.

Types of GCP inspections

GCP inspections are mainly carried out on a routine basis. Trials, clinics and companies are then selected following a risk-based assessment within the Swedish MPA.

• Inspection activities include Phase I-IV trials that may be initiated by pharmaceutical companies or academic organizations.
• Inspections are carried out on both ongoing and completed trials.
• Special risk trials are those involving investigational medicinal products containing an active substance not previously administered to humans, known as First In Human (FIH) trials. This imposes specific requirements on the competence of the investigator and other staff and on internal safety monitoring procedures for the subjects.
• Some clinics which carry out many FIH trials are regularly inspected.
• When other clinics act as trial sites in a FIH trial, an inspection may be carried out during the application period, as part of the assessment of the suitability of the site.
• Triggered inspections are carried out when the Swedish MPA has received indications that the quality of a trial is questionable.

How is a GCP inspection carried out?

A planned inspection is generally announced at least a few weeks in advance, and at that time some  documentation is also requested as part of the inspectors’ preparations.

An inspection at a clinic includes:

• interview;
• review of the investigator’s documentation (investigator site file) including patient binders, as well as medical records, case report forms (CRF), laboratory reports and other source data for comparison with that reported to the sponsor;
• visit to the trial site premises, including drug storage areas, sampling rooms, if any, and measuring equipment;
• visits to laboratories and pharmacies may also be included;
• the inspector’s final presentation with identified findings, and the possibility of explanations and clarifications from both sides.

The interview should involve, in addition to investigators and site staff, those who have been involved from the sponsor, for example in quality control or quality assurance, i.e. the monitor or the QA manager respectively.

A final written report will be finalised within a few weeks. The report describes the inspection procedure and the findings are graded according to their severity.

The final report is sent to the responsible investigator, the sponsor and any clinic manager or equivalent.

The investigator and the sponsor should provide a joint action plan to correct the findings and prevent the recurrence of identified deficiencies.

When the corrective and preventive actions are deemed acceptable, the inspection case is closed.

Processing of personal data for the purpose of inspection

Personal data will be processed by the Swedish MPA in connection with inspections and other supervision of clinical trials of medicinal products.

Personal data may include:

• name, position and contact details (email address, address, telephone number) of the persons with whom we correspond regarding the implementation of the inspection;
• name and position (in some cases also contact details and previous experience/training) of key personnel in the activity being inspected, and any contractors;
• name and position of any other person present at the inspection;
• any sensitive personal data or other personal data contained in the information under review.

The purpose of the processing of personal data is the control and supervision of clinical trials of medicinal products in Sweden. The legal basis for the processing is the exercise of public authority and the necessity for a task to be carried out in the public interest.

Personal data collected will be retained in accordance with the relevant archive legislation and documentation plans.

The Swedish MPA is the data controller for the processing. If you want to know if the Swedish MPA is processing your personal data, please contact the Agency.

If you want to change, add, request restriction or delete information about yourself, you can also contact the Swedish MPA. You also have the right to object to the processing of your personal data in certain cases.

If you have a complaint about the processing of your personal data by the Swedish MPA, you can contact the Swedish MPA and/or the Swedish Data Protection Authority.