Post authorisation processes

So good afternoon everyone. There's a couple of names that I don't recognize so I'll introduce myself. My name's Anne. I'm the QE2 Research Navigator and I form part of the Greater Metro South Facilitator Network and we're joined by those members today, Erica, Shona and Iona. So thank you everyone. And we're excited to bring you our presentation today, because it's the first time we've presented this topic to Metro South.

And when Jen and I saw that this training was coming up, we sat down and thought, what's something that we get regular questions on? And governance amendments was a topic that we thought would be valuable today. Um, so firstly, before we start, um, I'd like to just remind everyone that the session is being recorded and we acknowledge that your mics and cameras are off, but we will make them available at the end of the session when we have some question time.

We also have a feedback form for you to complete today. Um, it's really just a tool that the facilitator network are going to use to hopefully improve our sessions. Um, this is the first year we're doing this, so we're really just trialling an error, so any feedback is appreciated. Um, I'd also like to acknowledge the traditional, the traditional, um, we would like to respectfully acknowledge the traditional Aboriginal custodians of the land on which we all meet today across Metro South, their Elders past, present and emerging.

So, as you can see on the screen, we are joined by Jan today. Um, Jan is the Senior Research Governance Officer for Metro South with 15 years experience. Jan was initially a Contract Review Officer, which morphed into the Research Governance team. She's, she also has a background in commercial pharmaceutical companies prior to working at Queensland Health.

Um, Jan, having been impacted by family loss due to disease, um, it really means a lot for her to work in research, and she takes great pride in being able to help incredible researchers get their studies off the ground and has a deep respect for their efforts. So, thank you, Jan. I'll hand over to you. Okay, Anne.

Thank you so much for asking me to present and for your time and Iona's time and effort organising the webinar. And thank you to all those that have taken interest in our webinar today. Um, it's lovely to have you present. Even if it's virtually, I think COVID helped us towards this, so it's nice having that virtually.

It's a sunny day, I'm looking out at mountains from this office, so this is going to be a happy presentation based on the fact it's good for you psychologically to have a sunny day and see something beautiful. Now this presentation's been designed to provide information that will enable understanding of what Information is required by the Metro South Governance Office when you have completed and received your ethics approval for your project amendment.

So the question for you and we have research after research and not knowing what they need to submit for an amendment is what warrants of submission of a post authorization notification. We used to call these amendments in AURED, um, in ERM under the SSA to be submitted to the Metro South RGO. Thanks Ann.

Okay, so I've put here the four areas predominantly that governance looks at information and requires information. These are triggers. So when a change impacts the Metro South site, so it's any of our hospitals, within Metro South, Redmond, Logan, QE2, PA, um, communities, including mental health and Indigenous.

If there's a financial impact, if there's a contractual impact, external organisation involved, wanting to be involved in the research at Metro South, or even in some cases, other HHSs, site suitability. Is this research going to be suitable for our site and legislation? So these are the four areas that Metro South Governance requires submissions if there are amendments impacting any of these.

Thanks, Anne. Okay, me and my little quotes. This is a quote for this one. Right action is better than knowledge, but in order to do what is right, We now must know what is right. So you can submit something and go, wow, I did that. It was all correct, but did you really know what you're doing? So this is what this presentation is going to help you with.

And I've done it in such a way that when this presentation is finished, you can download it, have it on your desk, and use it. When you get a mentor and you go, oh, what do I need? This is a contract. This will help you step through the process. Thanks, Anne.

Okay, let's have a look when there's a financial impact and an amendment is required. What would trigger that? So you've already finalised, got your approved SSA, but now you need another department to support you. So you've sent your amendment into HREC. Is that going to cost us? Well, if yes, then we need an amendment, uh, the supporting departments providing staff will need an amendment, increasing patient payment, additional department or site, increase or decrease in human resources, or if the project requires equipment, treatment rooms, and then we need to know how payment will be provided.

Are we a bit delayed there? Is it coming through, Jen? No. Oh, it's just come up. Thanks, Sam. That's okay. So, changes to the study that impact the contract. We're finding the levels of contracts because external organisations are becoming involved, whether that's service level agreements, data transfer agreements.

We're having researchers involved as a collaboration, sponsors. There are changes that happen in a study. So you submit to ethics and there's a change to a principal investigator. That will definitely affect your contract. Even if it's associate investigators, some of the contracts like the HTQ, that's the agreement we have with universities.

That will definitely be impacted. So, um, we will need an amendment if there's a change in any of the investigators. If there's a change to the sponsor, definitely need a contract amendment. That will also impact. the indemnity and the insurance certificate. So we'll be looking for both of those in that type of amendment.

Change to the study title impacts the contracts. So we require that and it impacts the SSA so that moving forward we can actually make sure we put the correct study title in all approvals. Participant recruitment levels may change, which automatically affects payment, which then will require a contract amendment.

Expiry date of the agreement, we try to have the expiry date listed as, um, per ethics ceasing approval. If that's not in there and there's a date in there, that'll trigger an amendment. The contract was to finish today, the 14th of the 6th, um, in the expiry date, we would need, and the study's continuing for another two years, we would need an amendment to that agreement.

Financial changes. As per the previous, um, slide, this comes into the agreement where you'll need to have an amendment if their fee changes. As we get along in this presentation, you'll see. What is required for these changes, but here we're simply addressing what triggers the requirement for an amendment.

If there's an additional Metro South site, there'll need to be an amendment to the agreement or the addition of an agreement for any of the sites, if you have one site in the initial submission. If you decide, okay, we're going to need to use a particular company to put together the placebo for our study, it will trigger if you've got a current agreement with the sponsor, but we're doing a third party, um, inclusion where they're going to actually produce the placebo for us.

That triggers an additional agreement. It might be a supply agreement if they're supplying it without having making to make it. If there's a service they're providing, then we'll need a service agreement. So that will trigger that if we're doing a study currently and there is no agreement and you are accessing data or wanting to transfer data, a data agreement will come in, but we'll let you know which agreement is required for whatever amendment it is.

Change to any of the terms in the agreement. This generally happens with a sponsor or a major commercial company. They might want to change the terms. Um, or an international company. They might say we need to do changes here. That will trigger a contract amendment. Now the insurance certificate must always be supplied when the sponsor changes their name.

So, or it moves across to a different sponsor. So. Thanks, Anne.

Okay, legislation. When you've submitted something to ethics and there's a change that affects legislation, this is where governance engages and needs an amendment. So, Public Health Act, okay. So, you're drawing data, now you want ethics. A HDQ, that's a university agreement, um, to include, say, a University of Queensland researcher.

And you're going to provide them data, and that data is patient data in identifiable form. It triggers two things that have to happen. One, you need data custodian approval. And two You need public Health Act approval where you're accessing any of this data. Um, and even if you're extending the data range, so you'll need to provide that.

Now, that's not required if they're all Metro South researchers. Only when you're introducing someone not employed by Metro South or another hospital and health service, they will require it. Public Health Act to have them involved in seeing identifiable data. The only time that the PHA is not required is when you are accessing data, you're converting it to completely non identifiable data and then you're passing it over the counter to any external organisation.

You will need data custodian approval for any access to any retrospective data that you have. You're not obtaining consent from a patient or participant. Therapeutic Goods Act, um, we all know if there's a drug or device and, or if there's an addition of a drug or device to research, that'll trigger an amendment where you'll need to get, um, Therapeutic Goods Administration to provide an approval.

QCAT, um, Queensland, Sibyl. an administrative tribunal, um, you may be adding vulnerable population unable to consent themselves for themselves, then QCAT approval in certain instances needs to be provided. So that'll trigger an amendment to Metro South. And one that happens, these These four are predominantly the ones that we do have amendments come through.

Least of them is forensics and scientific services. When you're accessing coronial material you might want to add that to your research so that'll trigger an amendment. Thanks Sam.

So then, we know the four areas we need to look for when we have an amendment to identify RGO. RGO or Research Governance Office requirement of an amendment. What do I need to submit then for these? So financial change, your case form, so anything that you're adding staff and it's costing the department or they're doing in kind contribution that exceeds 10, 000 has to be signed by the PI, the head of department, and the business manager.

Anything under that doesn't require business manager sign off, but it does always require the PI, principal investigator, and the department head sign off. You'll need hatred approval if it affects adding researchers, payment made for their inclusion, etc. And if it affects a contract, the contract will be needed.

Thanks, Sam.

What do I need to submit for contract changes? So initially, start filling out your case form for that study. Um, the principal investigator, head of department and business manager will need to sign off again if it's over 10k, the business manager will need to sign. The contract amendment itself. Now, this has to be reviewed by Metro South outside of the ERM.

via our Metro South RGO email address. And it's in this slide for you prior to you putting it into ERM. So you can start the amendment under the SSA in ERM. Meanwhile, you're sending the contract or contacting So university is leading the study. They've provided you a draft data variation or whatever agreement they may have provided.

You then send that to us via our email address. We'll do the review. Once we're happy with the contents in there, we'll send it back to you and say forward this to the university for them to sign off. They'll provide it to you in PDF. This is the contract amendment that comes with case form. HREC approval if it applies to that contract amendment.

Sometimes you have finance change only. That doesn't require that you have HREC approval because they might be just increasing the per patient payment by a hundred dollars. So it really only affects sign off by the department head, the business manager. The contract amendment. But always upload to ERM our email that says we're happy with this final version, get the university, get the sponsor to sign off on this.

Keep that email, save it as RGO approval of amendment, and then send it to us. When you've got the final contract PDF back off the university or the sponsor, you upload it into the amendment in ERM under the SSA. So the hot, the underlined information here. Case form completed and signed, contract, HREC approval, RTO, research governance officer, review email are the four things that get uploaded for a contract review.

You don't have to worry about the content in the contract. We will. We'll talk to you about it. We'll talk to the university or sponsor and then we'll make sure it's correct. So you just need to load them. That makes your contract. Changes amendment. Thanks Ann. Okay, so legislative changes, what do I need for them?

That's the public health act. Qcat, vulnerable people, um, coronial material. Any of those changes, no doubt will have gone through hat. So we'll need the case form signed off by the investigator, the head of department. And HADRC approval. They're the only three things we'll need for that amendment, but yeah, that will help you get the legislative requirements through.

Thanks, Anne. General amendments. This is a good page because, um, what happens here, you sometimes only need one item to go into ERM under your SSA. Your annual report. We just need the annual report for the study that's being conducted. at a Metro South site. So you need that uploaded. Your insurance certificate, if it expires, is a very important document.

The insurance certificate can shut down your study because it actually covers any indemnity that may be placed against us or the sponsor. So it's very important to keep a track on that if you've got a sponsored study and make sure you record the date or have it. Um, regarding the insurance certificate, but we only need that uploaded to ERM.

We don't need any other documents. Change to sponsor financial details. So they might just say to you, Oh, we're no longer going to be requesting that payment be paid from this institution. It's coming from another. A letter of change will suit for that. If they provide a contract amendment, we'll deal with it.

But simply a letter notifying us that that will happen can be uploaded. Yes, I is. We don't require these, except if the principal investigator says, look, we really need to put that to the RGO. Or if it's gone to ethics because it's serious enough that it will suspend the study, then we'll also need ethics along with that.

But if you send one along, we will acknowledge that you've sent it and then just notify you. We don't need to be responsible for these. Um, because the SAE is the sponsor's responsibility. Now there's a whole new area where Metro South is doing a lot of sponsored studies. So, Sonia Hancock is working along with senior management to set up a committee that will deal with all the requirements that we will need to have submitted to governance.

in relation to a Metro South sponsored study. So stay tuned for that one. GCP Certificate for New Researchers. Okay, so this is talking about amendments, not the initial SSA. So if a new researcher is added to the study, we'll require a current GCP certificate. They normally last about three years, so we'll need a copy of that to be loaded in ERM.

No doubt you, some of you may have received our latest email. When it comes to sponsored studies, clinical trials, every research in the team, whether looking at data or involved actively with the participants, is responsible for providing their GCP certificate. So make sure that anyone listed on the SSA All the ethics submission, the GCP certificate is provided.

So thanks Anne. So how do I submit an amendment in ERM? Here's the process. So you can just download this one and when you're at work, you can go, okay, these are the steps I need to do to actually submit my amendment in ERM. So if you don't know what ERM is, Ethic Review Manager. Thanks Anne.

Okay, new studies. This isn't an amendment, but I just wanted to let you know we have a form that was developed, this form here. It's a guidance form that helps researchers. So, if you're really, oh, I don't know what to do and, It's too difficult to go on the website or you can either ask us to provide this to you for you because it gives you a step by step.

I'm doing a sponsored study. So what will I need? And I'll talk to you in here about agreements. They'll talk to you about insurances that will give you links where you need to go and we'll. You'll see this quite frequently as we move forward, come to you when we review your initial SSA and it'll have links in there that you don't even have to go outside of the document into the internet or intranet to find those links.

So, yeah, I'll be developing this into an amendment. Um, guidance and checklist form. So if you have an amendment. So thanks, Anne.

Okay, you're our priority. You're the, you're the teams out there that bring the working for us to do. And we love the efforts that the researchers, scientists, Unistudent sponsors go to to be able to commence their research and and help those out in the community that are suffering from light to very serious disease and the innovative research that we see come across our desk is amazing.

So we want to prioritize you and if you are not sure of anything at all, please call us. You can call us on the phone number that I've listed. That's the main incoming. There are others. We use that to vet calls. Um, you can contact us by email, make an appointment in person or virtually. Universities are loving the virtually.

Quite often I get requests to do that. So with COVID it opened that avenue and it's been really good at helping us face to face because sometimes you just want to see your face. As much as you do, we do as well. So all we want to do is make sure that we get your research across our desk and started. And I know that sometimes people feel that governance is quite exacerbating.

However, we're there every step of the way and we'd love to help you through the process. So thank you so much for being involved in this webinar today. Um, it's covered a bit of our amendments. The main areas where we get requests come through and questions come through. What do I need to do? There are other amendments, but not so frequent as what we have here today.

So thank you for being present today.

Thank you, Jan. That was a really useful and thorough presentation and even I learned something from that. I will now just unmute all participants so we can, um, answer any questions.

Iona, are you able to help me with that? I

should be all good now. Okay, thank you. Hi, Carol. I can see you've got your hand up.

Sorry, can you hear me? Yes, we can hear you now. Oh, thank you, Jan. That was great. I just wanted to ask a question so I can print it out. So people that are learning, we've got some sort of tool to use. You know that SSA checklist and guidance form? Where do I find that? Sorry, you might have said, but someone else was talking to me at the same time.

We, Anne is actually putting this into this presentation, isn't that correct Anne? Yes, I'm just trying to pop it into the chat, but Carol, you can find it on the Metro South research page on the quick links, tools, forms and templates. Okay. It is. Yeah, it is the second one from the bottom. Um. Yeah, awesome.

That's great to have it in my file. Yeah, thanks Jan. And if you, for some reason, lose it, just send us a quick email, Jan, and we'll send it back to you. No worries. Thank you.

Does anyone else have any questions? I have a question, Jan, and it's one that I get stumped with quite regularly is actually making the changes to the agreement. You mentioned the data variation, but I was just hoping you could go into a little more detail on, um, how we make those specific changes to the contract, if it is a change in title or a change in site.

Um, for example, are we track changing and where do we find a data variation? Okay, so generally if there's an external sponsor, they will provide the data variation to you. They know what they need to do. With the big commercial studies, it shouldn't fail. However, if it does, we do have templates. Um, I've had instances where researchers, there's one researcher in particular I'm thinking of, and um, an institution was to produce the variation, and um, they basically didn't put any information in.

So to prevent the researcher from having backwards and forwards, and to help them through the process, it wasn't our role to do it, but I filled out. track changes, always track changes in the initial draft. So you'll get a draft. It will be put into track changes. If it's not, make sure it is and then send it to us.

If we need any information, we'll ask you for that, um, that information and then we'll load it to the data variation. If it's our study, we'll generate it. And what is always good is when there is a change in study name, researchers, maybe payment, you might even have, and where the sponsor, apart from PACDU, they're very, and some of the other units.

Some are very, uh, proactive in putting together the information. Uh, we will, I will fill that out and make sure that all the information's there and I'll speak to the researcher. I've done this, this, and this. It's in track changes. Have a look at it, then send it back to me with the required changes that I've asked you for.

And I'll do is simple. Um, track in there or notes and I might have a note or you have this in here. However, I noticed in the protocol that says this. Is this correct? If so, check, um, leave it as it is. If not, can you change that? So clear instruction is given from us what needs to be in there. Generally, 80 percent of the time I'm dealing directly with the legal teams outside that are helping with the process.

So you'll have a deed of variation. So you're varying an agreement. You might have a deed accession where you have, this is generally not in clinical trials, but When you have, um, the universities involved, they like deed of accession. It's going to exceed the previous, um, agreement because two parties are dropping out and one's coming in.

So you will have that or you'll have a standard medicines. Australia, um, clinical trial agreement amendment for that. We have all the templates for amendments. The date of accession we're sourcing at the moment. So we have that in there because we're getting a few more. So track changes definitely. And We will notify you if a data variation is required.

If you're not sure of what's required, if it's ours, we are the sponsor, we'll already generate it with the track changes turned on. And generally we'll send it to the researcher or coordinator to provide information that we just can't source within the documentation that's been given to us. I'm sorry to have so many questions, but something else that I wrote down while you were talking is you mentioned a contract, a contract amendment may be needed when a new external party comes on.

So, a new university and you touched on that the governance team will let them know what agreement is required and I was just wanting you to maybe expand on that. It's a question I receive a lot as a navigator is. Is an agreement required and how do I know which one? So are we emailing governance or would you like us to communicate through ERM?

Okay, so what actually happens, you might have a team that they're all Metro South and then one of the Metro South researchers said I might change and do this under my University hat. So he'll either drop out as Metro South. Or he will do it both as Metro South and University. That triggers other things like a conflict of interest, which wasn't actually covered in this, um, presentation.

So automatically we'll look at the change. They'll come to us. We generally get an email and the researcher will say, Oh, I've just submitted to Ethics and I've got, um, a university student now involved. One of the researchers is changing over. We'll join you. researcher is coming in from university. Ethics might, um, have done the review and now they've received their approval and they're starting to do their amendments.

So they'll phone us, they'll email us, or they'll do something in ERM and it'll trigger us to be able to identify what is needed. So if it's a completely new, Research are coming from a separate institution. And if it's a university, there's specific agreements for that. Um, with the sponsored studies generally, only the PIs listed.

So it doesn't, um, affect that. So to look out, are they from Metro South? No, there's someone new. Go to your paperwork. Do I have a contract? No, they were all Metro South. Oh, so they're not from Metro South. I'll need to have an external, um, institution provide an agreement. Now, an important thing to remember too is we like to respect the external institutions, universities, etc.

So we'll generally say to the researcher, can you go to your UQ researcher and ask them to contact their relevant legal team to identify the agreement? Because we like to give them the courtesy, common courtesy to say We want this agreement. Generally, there's a whole suite of agreements that have been approved for universities and HHSs throughout Australia to be able to use.

So we give them that, um, dignity of selecting the agreement. Then they will contact us. They will send it to us or they will send it through the investigator to us. Either way. Um, we will always keep the research in the loop, what's happening with that agreement. Does that answer your questionnaire? Yep, it does.

And Jen, um, just because I'm aware of the research passport agreement, the Health Translation Queensland, I've just popped the link in the chat. So for any teams that are collaborating with the university, this may be the preferred template because it's already approved by all the partners. So it's just something to be aware of this link.

And if. Um, the terminology HTQ is mentioned to you. This is what they're referring to and remembering that agreement is only for the partners listed on the front page of that. agreement to say if you've got University of Southern Queensland, they're not a partner. So then you'll come to us and we'll provide the relevant um, agreement.

We do have links on our website and the guidance form is very good that has been set up. It gives you all the links for the different contracts. So you can go in there and play and say, Oh, if I did this with my research, which agreement would I need? You can do a little bit of, um, Fact finding, I find a crossword puzzle.

Yeah. Um, so if you are, um, making changes to your study and you've submitted to ethics and you're still not sure whether you are required to submit something to governance, do contact the team, um, and they can determine that for you and provide some guidance on what documents are required. But does anyone have any other questions before we finish up for the day?

No, if you think of something after or I find in the research sphere, it's an information access point. So as you're doing the work, that's when questions really come up. So please reach out to any of us in the Metro South Facilitator Network or Jan's team and we'll be able to support you. But I'd just like to thank everyone for joining today and I hope you found that really valuable and I wish you all the best with your research.

so much. Thank you, Anne. Thanks, Jen. And thank you, guys. Thank you, Iona and Shona. Oh, yes, thank you, Shona. On behalf of us, it's just lovely. The researchers are feeding back beautiful information about your support, so thank you so much. And it's, it's great to see you. bringing into our office very clean submission.

Thank you, Jen. Uh, just showing a reminder. Thank you for reminding me. Ethics is on tomorrow at the same time, so hopefully we will see you all again there. And thank you, Jen.