New NHMRC guidelines for safety reporting

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4 years 2 months ago #13 by suenr
suenr created the topic: New NHMRC guidelines for safety reporting
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4 years 2 months ago #14 by mgambrill
mgambrill replied the topic: New NHMRC guidelines for safety reporting
NSW Health has not adopted the guidelines.
Local HREC sending letter of protest.
No NSW HRECs will be able to adopt changes ti approved by NSW Health.
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4 years 2 months ago #15 by Roslyn
Roslyn replied the topic: New NHMRC guidelines for safety reporting
Wow- this is going to decrease our repetitive work significantly. As well as increasing the responsibility for sponsors to review properly.

I do know that QLD site has implemented already- so implemented for one one our trials where they are LEAD. Wonder how long it will take NSW Health?

My passion- collaboration in clinical research.
My passion- travelling- just got back from Egypt!
:)

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4 years 2 months ago #16 by Roslyn
Roslyn replied the topic: New NHMRC guidelines for safety reporting
Local HREC- are they against the procedure, or against NSW health not approving the guidelines yet?

My passion- collaboration in clinical research.
My passion- travelling- just got back from Egypt!
:)

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4 years 2 months ago - 4 years 2 months ago #17 by mgambrill
mgambrill replied the topic: New NHMRC guidelines for safety reporting
Our HREC would love to implement but sent the following when we asked about it: the "OHMR at the Ministry won't let us - I am writing a letter in protest!"

She is hoping they may be approved by July2017. I think other HRECs could help by also writing letters.

Before everyone gets excited and starts re writing SOPs be aware that NSW has not adopted the guidelines.
Our local HREC is writing letter of protest and would suggest that CTC’s bring this to HREC attention if they haven’t heard yet as this puts us at disadvantage over other sites (if they adopt same) as we in NSW will be doing a lot more work and asking for documents from other states that they are not required to provide.
Last Edit: 4 years 2 months ago by mgambrill. Reason: more info

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4 years 2 months ago #18 by Roslyn
Roslyn replied the topic: New NHMRC guidelines for safety reporting
I'll ask our HREC too.

Has anyone else have HREC advice?

My passion- collaboration in clinical research.
My passion- travelling- just got back from Egypt!
:)

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