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Amendments

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Amendment to the Research Project

Notifications of amendments to approved research projects must be submitted to the Ethics Secretariat for review by the PAH HREC with a covering letter which includes:

• PAH HREC Protocol Number
• Research Project Title
• outline of the attached documents
• any other changes outlined under individual items e.g. CTNs, Researchers.

All items that require multiple copies must be collated, with a copy of the covering letter at the front of each bundle.

 

Amendment Submission Requirements

Please consult the following link which outlines copies required for amendment applications and note the following instructions:

• Provide 1 original and 17 copies of relevant documents with changes tracked.  Added text is to be highlighted or underlined, and deleted text is to be struck through.
• Include a ‘Summary of Changes’ if an amended sponsor-initiated Clinical Trial Protocol or Investigator Brochure is submitted.
• Update version number and date if documents have version control.

 

Review and Approval Process

Executive approval of amendments may be provided between meetings by the HREC Chair, as outlined in Chapters 5.1.18 and 5.1.19 of the NHMRC’s National Statement on Ethical Conduct in Human Research 2007 if the risk is low. If a detailed examination is required the Chair of the HREC may refer an amendment to the next HREC meeting.

 

Other than for minor administrative changes or compromise of patient safety caused by any delay, changes require a formal HREC approval letter prior to their implementation.

 

Fees

All major amendments to previously approved pharmaceutically sponsored Research Projects that are submitted to the PAH HREC for review are subject to a levy of $550 (inclusive of GST) and are required to include a Raise Invoice Memo - Amendments.

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