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Frequently Asked Questions

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Frequently asked questions for filling out applications

You intend to submit an application and

·         Your research does not involve drugs and is not industry sponsored, or

·         Your research study is commercially or industry sponsored, or

·         Your research study involves the use of drugs but is not industry funded

You need to report a Serious Adverse Event

You want to make an amendment to a HREC approved project

You need to submit an Annual Report

Answers

You intend to submit an application and your research does not involve drugs and is not industry sponsored

All applications to the Human Research Ethics Committee must include the following:

·         Seventeen copies must be submitted to Ethics Secretariat of the research protocol, patient information sheet on a Queensland Health letterhead and footer identifier , patient consent form and all advertising / marketing material that is to be given to patients. Please ensure that you as the submitter also keep 1 copy of everything for your records – required for auditing and monitoring.

·         1 copy of the Summary Submission Form

·         1 original signed Resource Form

·         1 copy of Checklist

You intend to submit an application and your research study is commercially or industry sponsored

All applications to the Human Research Ethics Committee must include the following:

·         Seventeen copies must be submitted to Ethics Secretariat of the research protocol, patient information sheet on a Queensland Health letterhead and footer identifier , patient consent form and all advertising / marketing material that is to be given to patients

·         1 copy of the Summary Submission Form

·         1 original signed Resource Form

·         1 copy of Checklist

Please ensure that you as the submitter also keep one copy of everything for your records as a requirement for auditing and monitoring.

You intend to submit an application and your research study involves the use of drugs but is not industry funded

All applications to the Human Research Ethics Committee must include the following:

·         Seventeen copies must be submitted to Ethics Secretariat of the research protocol, patient information sheet on a Queensland Health letterhead and footer identifier, patient consent form and all advertising / marketing material that is to be given to patients. Please ensure that you as the submitter also keep 1 copy of everything for your records – required for auditing and monitoring.

·         1 copy of the Summary Submission Form

·         1 original signed Resource Form

·         1 copy of Checklist

In addition to the above you must submit the following:

·         Any information that will be given to patients eg quality of life forms must also be submitted

·         TGA Clinical Trial Exemption (CTX) and Clinical Trial Notification (CTN) scheme must be specified and requirements must be met. The CTN form must be signed by the Principal Investigator before submission which is countersigned by the District Manager upon approval.

·         Indicate indemnity arrangements.

You need to report a Serious Adverse Event

For PAH SAEs, complete the PAH Serious Adverse Events form. For other SAEs the Serious Adverse Events form.

You want to make an amendment to a HREC approved project

Submit details of amendment - old and new wording should be supplied where this has been changed which will be sent to you. Further information.

You need to submit an Annual Report

Complete form (MS Word, 40 kB).

 

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