Site inspections

When is an inspection carried out?

Not all studies will be subjected to an inspection. Some studies are selected randomly for routine surveillance. An inspection may also be triggered when: ⁽¹⁵⁾

• A study has been identified as high risk during the initial ethics application
• Researcher has frequently failed to submit progress reports
• A study has significant numbers of SAE and/or non-compliance incidents
• There are complaints against a researcher or a study.

What happens during an inspection?

You will usually be forewarned about an upcoming inspection so that you have enough time to prepare for it.

Inspectors may require access to all research files and documents, including confidential information of subjects. They may also interview members of your research team and observe your facilities.

When an issue has been identified, photographs and photocopies of documents may be taken to serve as evidence. A full inspection could take several days. ⁽²⁴⁾

What are the possible outcomes?

At the end of an inspection, the inspectors will usually present their key observations to your team and give you an opportunity to clarify issues. This will be followed by a formal letter to you.  You will be asked to implement corrective actions within a given timeframe if non-compliance issues were identified. ⁽²⁵⁾

Failure to co-operate during an inspection and failure to take prompt corrective actions could lead to further actions such as suspension and termination of ethics approval, or blacklisting.   

Who else may conduct an inspection?

Similar inspections may also be carried out by regulatory authorities such as the NPRA and MDA. Refer to the Malaysian Guideline for Good Clinical Practice (GCP) Inspection (NPRA, 2018) for examples of inspection findings that are classified as minor, major or critical. ⁽²⁵⁾