Good Clinical Practices (GCP) audits are crucial to Clinical Research Organizations (CRO’s). This is because they deal with very vital human life for their research. The implications of the research can be very profound. They can change the way diseases are managed, or if done incorrectly or without adherence to sound Good Clinical Practices audit practices, could lead to serious repercussions for the subjects.
GCP audits and regulatory bodies
The core reason why Good Clinical Practices audits are very important is that regulatory bodies across the world have strict guidelines on how to implement them. The International Conference on Harmonization (ICH), a global harmonization taskforce, has many guidelines on how to implement Good Clinical Practices audits that comply with best practices. Likewise, the FDA too, has very stringent compliance Good Clinical Practices requirements that CRO audits have to adhere to.
GCP audits begin with the sponsor. The sponsor is the organization that conducts the clinical research study, and is thus responsible for ensuring that the Good Clinical Practices audits are carried out for the study they undertake. The sponsor should ensure the adherence of Good Clinical Practices audit standards and methodologies, as well as the safety and rights of the subjects. An established good practice is to have the internal audit done and then getting it corroborated by an external one.
The role of the auditor is all important
Another key role in Good Clinical Practices audits is that of the auditors. Whilst they can be either internal or external, there are different rules that govern the conduct of each of these types of GCP auditors. There are clear rules as to their
- Audit plan (written procedures)
- Goal setting
During the audit
During the actual conduct of the Good Clinical Practices audits; the auditor has to explain to the sponsor the purpose of the audit, the documents required for this, and the requirements on the part of the CRO for ensuring the smooth conduct of the Good Clinical Practices audit, and should provide a checklist of all these.
After the audit
The Good Clinical Practices auditor should suggest Corrective and Preventive Actions. These findings should be reported to the person or office designated by the regulatory bodies, after which an Audit Certificate is issued, and the Good Clinical Practices (GCP) audit records are filed and maintained according to set procedures.
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