General Instructions
- Search the site to see whether the study or studies you require are already listed. Note: you do not
need to create an account to search for a study.
- Before you can select studies or initiate a request you need to Login or Create an account.
- If the study or studies of interest are already listed then you can add these to your List of Selected
Studies by clicking on the green “+ “button. The View Selected Studies icon will appear.
- Click on the View Selected Studies icon to initiate a Research Proposal , or Add more Studies, or Ask a
question about your selected studies.
- You can also delete any studies from your List by clicking on the red “-“ button.
- Once you have clicked on “Initiate Research Proposal”, follow the instructions within the research
proposal template to complete your application and then click on either “Save” if you wish to complete
it later or click on “Submit” if you are ready to submit this.
- If the study or studies of interest are not listed, then you can submit an Enquiry .
Search Studies listed on this site
You can view studies listed on this site via the Search bar on the Home page by either using the Keyword
Search functionality (if the study identifier or title is known) or by clicking on "Browse All Studies".
You can then filter by Sponsors, Phase, Medical Condition or Medicine or a combination of these to refine
your search.
You can also search for a study by entering the study identifier or title in the Search bar.
Create Account
A user account is needed to submit a Research Proposal, to submit an Enquiry for a non-listed study or Ask a
question about a study listed on this site.
Click here to create an account.
Submit a Research Proposal
You must login or create an account before you can submit a Research Proposal.
Once you have selected the study or studies of interest and added them to your List of Selected Studies, you
can Initiate a Research Proposal. Follow the instructions within the Research Proposal Template to
complete your application and then click on either “Save” if you wish to complete it later or click on
“Submit” if it is complete.
Please note that after you have submitted your Research Proposal you will not be able to make changes (e.g.
add or delete studies), so please ensure that you have carefully selected all the studies you require.
If you have submitted an Enquiry then please wait for the outcome of the Enquiry before you submit your
proposal.
Checklist for Researchers
Submit an Enquiry
You must login or create an account before you can submit an Enquiry.
Researchers can submit an Enquiry to ask about the availability of data from studies not listed on this
site. If you are looking for a study and you are unable to find the study, click the "Initiate an Enquiry"
button.
Please provide as much information as possible to help the relevant Sponsor(s) identify the study e.g.
Sponsor name, Sponsor study identifier and/or other identifiers (e.g. NCT ID, EudraCT ID, PubMed ID), and
the study title plus any other relevant information.
Please refer to the Sponsor Specific Details available from the Sponsors
pages.
Ask a question about a study listed on this site
You must login or create an account before you can Ask a Question.
You can submit a question about a study listed on this site by searching for the study and clicking the
“Study ID”. This opens up the study details page. Scroll down to the bottom of the page and click the “Add”
button. This will add the study to your List of Selected Studies.
If you are seeking access to study documents only and not the patient-level data, please refer to the
Sponsor Specific Details available from the Sponsors pages.
Review of Requests
Research Proposals are checked and reviewed in 3 stages: Stage 1, by the secretariat for the Independent Review Panel (IRP) ; Stage 2, by the study Sponsors; Stage 3, by the IRP.
Review of Research Proposals
1. Stage 1 - Secretariat for the IRP:
| 1.1
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A qualified statistician is a member of the research team
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| 1.2
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All solicited fields are completed
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| 1.3
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The researcher plans to publish the analysis results
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If one or more of these checks fail, the proposal will be returned to the researcher for further information.
If all of these checks pass, then the proposal will advance to stage 2.
2. Stage 2 - The Study Sponsors check the following:
Sponsors generally review for the criteria below. Note that some Sponsors may opt out of a particular check. See individual Sponsor pages for details of each Sponsors' policies.
| 2.1
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The Research Proposal is compatible with study informed consent
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| 2.2
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The data and studies are available to perform the analysis
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| 2.3
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The planned analysis can be conducted in the data access system
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| 2.4
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The Research Proposal does not compete with Sponsor's publication plan
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| 2.5
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Additional information that may be relevant to complete the review
This is generally to provide information to the researcher or for the researcher to provide additional information to the Sponsor, if clarification is needed
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| 2.6
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Under exceptional circumstance, for some Sponsors only - check for a potential conflict of interest or an actual or potential competitive risk
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A conflict of any of these checks could result in a decline of the Research Proposal, or a request for re-work or further information from the researcher.
If declined by the study Sponsor, the rationale will be provided to the researcher and is made available in the Metrics section of this site, which is updated on a regular basis.
If all of these checks pass, the Research Proposal will advance to stage 3.
3. Stage 3 Review - The Independent Review Panel considers the following:
| 3.1
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The scientific rationale and relevance of the proposed research to medical science or patient care.
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| 3.2
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The ability of the proposed research plan (design, methods and analysis) to meet the scientific objectives. This is a high-level review.
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| 3.3
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The publication plan for the research.
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| 3.4
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Real or potential conflicts of interest that may impact the planning, conduct or interpretation of the research and proposals to manage these conflicts of interest.
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| 3.5
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The qualifications and experience of the research team to conduct the proposed research (a statistician with a degree in statistics or a related discipline should be part of the research team).
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Before completing its review, the IRP may ask for additional information from the researcher and if needed seek additional expert advice.
Decisions the Independent Review Panel can make
The Independent Review Panel will make one of the following decisions:
- Approval to provide access to the requested data.
- Declined with advice to re-submit the Research Proposal.
- Declined Research Proposal.
The panel chair informs the IRP Secretariat and relevant study Sponsor or Sponsors of the decision and provides any conditions of access and the rationale why a Research Proposal is not approved. For declined IRP Research Proposals, the rationale is communicated to the researcher. There is no appeal process. For approvals, the Data Sharing Agreement will thereafter be sent by the Sponsor(s).
An overview of the number of Research Proposals submitted and the outcome of the IRP's review is made available in the Metrics section of this site and updated on a regular basis.
Researchers must not use approval by the IRP as scientific endorsement for funding or publication.
Researchers are responsible for gaining any other approvals that are required for the research (for example, from Ethics Committees, Institutional Review Boards, relevant research institutions or funding bodies).
The Independent Review Panel is listed here.
When a decision can be expected
If no further information is needed, and depending on the number of requests received, it is anticipated that the decision from the panel will be communicated approximately 90 calendar days of a Research Proposal being submitted. Researchers will be notified when it is anticipated that the data for their research will be made available.
Review of enquiries to access data from studies not listed on this site
If an enquiry facility is provided, enquiries are answered by the relevant Sponsor(s). Where Sponsors are able to provide access to the data, access will be provided if the Independent Review Panel approves a submitted Research Proposal that includes these studies and the relevant Sponsor(s) receives a signed Data Sharing Agreement.
Review of enquires to access study documents without patient level data
These enquiries are answered by the relevant Sponsor(s). Further information about Sponsors' policies are provided in Study Sponsors section of this site.
Request Flow Diagram
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