GCP inspections- topics of interest

Electronic Health Records (eHR) are increasingly being used to collect data for clinical trials. While we support the move towards eHR, it is important that any data collected for clinical trials is compliant with GCP and applicable regulations.

We strongly advise that hospitals or other institutions get input from clinical trial practitioners on the requirements for clinical trial source documentation prior to the introduction of an eHR system. When setting up an eHR system (or when updating an eHR that has already been established), the following should be considered:

• The integrity of the data should be maintained, through processes including ongoing data review, change control, access control, and clear audit trails.
• The system should have audit trails that show who had access to what patients and data, what was reviewed, what entries and changes have been made, by whom and when
• The system should have adequate levels of security, so people can only access and edit what they are authorised to
• The investigator should still be able to demonstrate their medical oversight of the trial when eHR systems are used. For example, where all entries into the medical records are made by a research nurse it can be difficult to reconstruct the investigator's input. A process should be added to the system to allow investigators to verify the information recorded in the same way a paper record would have been signed and dated.
• Access to the system (including audit trials) should be available for inspectors and sponsor representatives (e.g. monitors and auditors), which is limited to trial subjects only. This would allow source data verification of clinical trial subjects while protecting the confidentiality of other non-trial patients.
• There should be a way to flag clinical trial participants (similar to a having a sticker on their chart) and a way to search for records.
• There should be a way to appropriately archive any records created in line with regulatory requirements (at least 25 years for trials under the Clinical Trial Regulation).
• The system should meet the basic requirements for computer systems that are used in a clinical trial (including physical security, restricted access, data protection, back-up of systems).
• Written procedures (SOPs) should be available that outline how the system will meet the above requirements.

This guidance should be considered along with your institution's requirements for standard health care records and other applicable regulations and guidance (such as data protection legislation).

You can find further information on computerised systems for clinical trial in the  Guideline on computerised systems and electronic data in clinical trials issued by the EMA GCP Inspectors Working Group.

There are rules in Irish national law which define who can obtain informed consent in clinical trials. These rules are different for trials that are authorised under the Clinical Trials Directive (CTD) or the Clinical Trials Regulation (CTR).

The rules for informed consent in trials under the Clinical Trials Directive are defined in Schedule 1 of S.I 190 of 2004 (as amended). These regulations require that a trial participant has had an interview with an investigator or another member of the investigating team, before informed consent to take part in the trial is obtained. An investigator is defined in the legislation as being a registered medical practitioner (e.g. a medical doctor) or registered dentist.

Therefore, there must be documented evidence available that the trial participant was interviewed and that consent was obtained by an investigator. Other study personal, such as research nurses, may be involved in supporting the informed consent process.

The rules for informed consent in clinical trials under the Clinical Trials Regulation are defined in Chapter V of the CTR, and are further defined under national law. In Ireland, the national rules for who may obtain informed consent are defined under Part 4 of S.I 99 of 2022 (as amended). These regulations require that the informed consent interview is conducted by the investigator or by a registered medical practitioner, a registered dentist, or a registered nurse, whose training, experience and qualifications have been assessed by the investigator and determined to be appropriate to qualify them to conduct the interview.

If an investigator has determined someone as suitable to obtain informed consent, that person should be clearly delegated this task by the investigator. The investigator would still be required to have oversight of the informed consent process, as with any other delegated tasks. This oversight should be appropriately documented so that it can be demonstrated on inspection.

It is also important to highlight that the investigator will still be responsible for determining if a subject is eligible to enrol in a trial, regardless of whether the task of obtaining informed consent has been delegated.

You can find further information on informed consent in the  Guide to clinical trials conducted under the CTR in Ireland.

You can find further information about clinical trials in our dedicated section of the website.

There are different rules for reporting serious breaches for trials that are authorised under the Clinical Trials Directive (CTD) or the Clinical Trials Regulation (CTR).

For trials authorised under the Clinical Trials Directive, there is no obligation for sponsors to report serious breaches to the HPRA. However, any serious breaches that are reported on a voluntary basis will be accepted.

There are however other activities that must be reported to the HPRA, including urgent safety measures and suspensions to a trial. Further information on these can be found in the HPRA's Guide to clinical trials authorised under the CTD.

For trials authorised under the Clinical Trials Regulation, sponsors are required to report serious breaches through the Clinical Trials Information System (CTIS).

A serious breach is defined in the CTR (Article 52) as a breach likely to affect to a significant degree the safety and rights of a subject or the reliability and robustness of the data generated in the clinical trial.

If investigator has determined someone as suitable to obtain informed consent, that person should be clearly delegated this task by the investigator. The investigator would still be required to have oversight of the informed consent process, as with any other delegated tasks. This oversight should be appropriately documented so that it can be demonstrated on inspection.

For further information, please see the EMA's Guideline for the notification of serious breaches of Regulation (EU) No 536/2014 or the clinical trial protocol on reporting of serious breaches.

You can find further information about the Clinical Trials Regulation (CTR) on our dedicated page.