17 januari: Quality control, Quality assurance & Site audits

Question 1

What is the difference between Quality control & quality assurance?

Answer 1

QC = checking boxes (investigational team)
QA = Men In Black (independent audits, such as those performed by the man, the myth, the legend)

Question 2

What is QC?

Answer 2

The operational techniques and activities undertaken within the quality assurance system to verify that the requirements for quality of the trial-related activities have been fulfilled (self-control). Ongoing activity.

Question 3

What is QA?

Answer 3

All those planned and systematic actions that are established to ensure that the trial is performed and the data are generated, documented, and reported in compliance with GCP and the applicable regulatory requirements. Snapshot.

Question 4

Name and describe the types of QA audits.

Answer 4

1) investigator site
2) contractor (e.g. labs/facilities)
3) system and process (e.g. computer system)
4) Clinical Trial report (+CSR)
5) Sponsor trial files
6) databases
7) Good Manufacturing Practice (=GMP) audits

Question 5

What is the difference between auditors and inspectors?

Answer 5

Auditors are hired by sponsor/CRO, whereas inspectors come from RAs and ECs.

Question 6

When do regulatory authority inspections usually take place?

Answer 6

During MAA period, also increasingly during ongoing trials.