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Managing approved projects


Ethics approval is not a one-time event. It creates ongoing obligations that continue for the life of a project and, for research data, beyond it. This section sets out what an approved project must do to remain compliant: submitting amendments when the protocol changes, reporting progress, seeking more time where needed, handling adverse events and complaints, closing the project out, and retaining data appropriately afterwards.

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Amendments

When and how to submit changes to an approved protocol, including team changes.

Extensions of time

Requesting more time to complete an approved project.

Annual and final reporting

Reporting obligations during and at the conclusion of the project.

Adverse events

Reporting obligations for adverse events and other significant safety issues.

Complaints

Handling participant complaints about an approved project.

Data retention

Post-completion data management requirements.