Common findings in clinical trials regulatory inspections include non-compliance with Good Clinical Practice (GCP) guidelines, inadequate documentation and record-keeping, and failure to report adverse events. Other common findings include issues with informed consent, inadequate monitoring of the trial, and deviations from the study protocol. These issues can lead to delays or even termination of the trial, as well as fines or other penalties for the sponsoring company. To avoid these issues, it's important for companies and research organizations to have robust systems in place to ensure compliance with GCP guidelines and to accurately document and report all aspects of the trial.

Some of the most common findings:

• Non-compliance with Good Clinical Practice (GCP) guidelines
• Inadequate documentation and record-keeping
• Failure to report adverse events
• Issues with informed consent
• Inadequate monitoring of the trial
• Deviations from the study protocol
• Incomplete or inaccurate data
• Lack of standard operating procedures (SOPs)
• Lack of qualified staff
• Lack of proper training for staff involved in the trial.

1. Non-compliance with Good Clinical Practice (GCP) guidelines

Non-compliance with Good Clinical Practice (GCP) guidelines: GCP guidelines are a set of internationally recognized standards that outline the ethical, scientific, and practical aspects of clinical trials. FDA inspectors may find that a trial is not in compliance with GCP guidelines if the trial is not being conducted in an ethical manner, if the trial design is not scientifically sound, or if the trial is not being conducted in a practical and efficient manner. Investigator is not obtaining informed consent from participants in a proper manner, or not reporting adverse events in a timely manner.

2. Inadequate documentation and record-keeping

Inadequate documentation and record-keeping: FDA inspectors may find that a trial does not have proper documentation and record-keeping systems in place. This can include missing or incomplete case report forms, missing informed consent forms, or missing or incomplete adverse event reports.

3. Failure to report adverse events

Failure to report adverse events: FDA inspectors may find that a trial is not reporting adverse events in a timely manner, or that the trial is not reporting all adverse events that occur during the trial.

4. Issues with informed consent

Issues with informed consent: FDA inspectors may find that a trial is not obtaining informed consent from participants in a proper manner, or that the informed consent forms used in the trial are not compliant with FDA guidelines.

5. Inadequate monitoring of the trial

Inadequate monitoring of the trial: FDA inspectors may find that a trial is not being adequately monitored by the sponsor or the research organization. This can include a lack of on-site monitoring visits, or a lack of follow-up visits with participants.

6. Deviations from the study protocol

Deviations from the study protocol: FDA inspectors may find that a trial is deviating from the study protocol in a significant manner. This can include changes to the trial design, changes to the inclusion/exclusion criteria, or changes to the dose or frequency of the study drug.

7. Incomplete or inaccurate data

Incomplete or inaccurate data: FDA inspectors may find that the data collected in a trial is incomplete or inaccurate. This can include missing data points, errors in data entry, or inconsistencies in the data.

8. Lack of standard operating procedures (SOPs)

Lack of standard operating procedures (SOPs): FDA inspectors may find that a trial does not have appropriate SOPs in place for the conduct of the trial. This can include SOPs for the handling of study drugs, SOPs for the monitoring of the trial, or SOPs for the reporting of adverse events.

9. Lack of qualified staff

Lack of qualified staff: FDA inspectors may find that the staff involved in a trial are not qualified to perform their duties. This can include a lack of medical or scientific qualifications, or a lack of experience conducting clinical trials.

10. Lack of proper training for staff involved in the trial.

Lack of proper training for staff involved in the trial: FDA inspectors may find that the staff involved in a trial have not received proper training in GCP guidelines, or in the conduct of the trial. This can include a lack of training in the use of study drugs, or a lack of training in the reporting of adverse events.

Example :

Here are a few examples of GCP violations by the leading global pharmaceutical companies during clinical trials:

• In 2019, a leading global pharmaceutical company received a warning letter from FDA for GCP violations during a clinical trial for a cancer drug. The violations included failure to properly report adverse events and failure to properly maintain study records.
• In 2018, a major global MNC received a warning letter from FDA for GCP violations during a clinical trial for a diabetes drug. The violations included failure to properly report adverse events and failure to properly maintain study records.
• In 2017, a leading global pharmaceutical MNC received a warning letter from FDA for GCP violations during a clinical trial for an obesity drug. The violations included failure to properly report adverse events and failure to properly maintain study records.
• In 2016, a leading global MNC received a warning letter from FDA for GCP violations during a clinical trial for a schizophrenia drug. The violations included failure to properly report adverse events and failure to properly maintain study records.
• This write up has been authored by Kamal Shahani , Founder and Managing Director, Cliniminds. Cliniminds is the leading life sciences sector skilling organization. Cliniminds offers wide range of job oriented programs, up-skilling program and corporate training solutions in the field of clinical research, clinical data management, pharmacovigilance, QA Audits & Inspections, SAS, business analytics, biostatistics, medical writing, medical devices and regulatory affairs.

This write up has been authored by Kamal Shahani , Founder and Managing Director, Cliniminds. Cliniminds is the leading life sciences sector skilling organization. Cliniminds offers wide range of job oriented programs, up-skilling program and corporate training solutions in the field of clinical research, clinical data management, pharmacovigilance, QA Audits & Inspections, SAS, business analytics, biostatistics, medical writing, medical devices and regulatory affairs.