Obligations under controlled trials
179C Obligations under controlled trials
Entities released from obligations
If an entity holds an approval, that is in force, to participate in a controlled trial, the entity is released from an obligation that the entity would otherwise be required to satisfy under a controlled trial provision if the obligation is specified in the rules as an obligation in relation to that trial that entities are released from.
Section 179L provides for the making of rules to establish a controlled trial. Division 3 deals with approving an entity’s participation in a controlled trial.
For controlled trial provision, see subsection 4(1).
Entities must satisfy obligations in a different way
If an entity holds an approval, that is in force, to participate in a controlled trial, the entity cannot satisfy an obligation under a controlled trial provision in the way required by this Act if the obligation is specified in the rules as an obligation in relation to that trial that entities cannot satisfy in the way required by this Act.
Instead, the entity must satisfy the obligation in the way specified in the rules in relation to that trial.
A failure to satisfy the obligation in this way is a ground for varying, suspending or revoking the entity’s approval: see section 179J.
Entities must comply with additional obligations
If an entity holds an approval, that is in force, to participate in a controlled trial, the entity must comply with each obligation specified in the rules as an obligation in relation to that trial that entities must comply with.
The obligation must be in relation to a controlled trial provision: see paragraph 179L(3)(h).
A failure to comply with the obligation is a ground for varying, suspending or revoking the entity’s approval: see section 179J.
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