CHAPTER IIINSPECTORS

Article 5Conflict of interest and impartiality

1.

Inspectors shall be free from any influence which could affect their impartiality or their judgement.

2.

Inspectors shall not have conflicts of interest. In particular, they shall be independent of all of the following parties:

(a)

the sponsor;

(b)

the investigators involved in the clinical trial;

(c)

persons financing the clinical trial;

(d)

any other party involved in the conduct of the clinical trial.

3.

Each inspector shall make an annual declaration of their financial interests and other links to the parties to be potentially inspected. That declaration shall be taken into consideration for the purposes of assigning an inspector to a specific inspection.