Metrics
CSDR Cycle Times for Research Proposals submitted in 2025 (N-24)
Median 0.8 months
Range 0-6 months
|
Median 1.9 months
Range 0.6-5.6 months
|
Median .4 months
Range .06-.2 months
|
Median .82 months
Range .3-.366 months
|
|
Primary factors that affect the timelines:
- Institution's DSA review process
- Response to questions from IRP Secretariat
- Sponsor review meeting schedules
- Ongoing enquiry for studies not listed on CSDR
|
IRP Sec. = IRP Secretariat
DSA = Data Sharing Agreement
IRP = Independent Review Panel
|
*
Note that DSA Review and Sign-off period can be greatly reduced if the
standard DSA is accepted
Studies (Up to 1 June 2025)
The total number of studies listed on this site is 2988.
Research Proposals requesting access to patient level data (Up to 1 June 2025)
A summary of the number of Research Proposals received via this site since May 2013 is provided here and is updated bi-monthly.
The table below provides metrics for different parts of the process following submission of a Research Proposal (Requirements check, Independent Review Panel (IRP) review, Data Sharing Agreement, Data preparation, Data Access and Publication). The "In process" rows provide the number of Research Proposals in this part of the process. The other rows for each part of the process provide the total number of Research Proposals that have achieved that outcome. Metrics include previous and current Consortium Members.
| Number of Research Proposals submitted up to 1 June 2025 |
802 |
| Requirements check |
In process |
5 |
| Withdrawn by the requestor |
79 |
| No response received |
64 |
| Did not meet requirements |
32 |
| Potential conflict of interest or an actual or potential competitive risk |
2 |
| Met requirements |
619 |
| IRP review |
In process |
3 |
| Withdrawn by the requestor |
7 |
| No response received |
11 |
| Rejected or advised to re-submit
|
92 |
| Approved or approved with conditions |
506 |
| Data Sharing Agreement |
In process |
38 |
| Withdrawn by the requestor |
45 |
| No response received |
17 |
| Not agreed by requestor |
6 |
| Agreed (signed)
View details of these Research Proposals |
400 |
| Data preparation |
In process |
10 |
| Withdrawn by the requestor |
3 |
| No response received |
4 |
| Complete (data available) |
383 |
| Data Access |
Access provided |
143 |
| Withdrawn by the requestor |
13 |
| Access closed |
225 |
| Publication |
| Publication anticipated
|
51 |
Published
View details of these Research Proposal Publications (226) |
140 |
| Withdrawn by requestor
|
176 |
| No response received
|
18 |
| Publication not received after 18 months of Access Closed |
22 |
Multi-Sponsor Research Proposals were possible starting 1 January 2014. Out of 780 proposals submitted since 1 January 2014, 138 were multi-Sponsor proposals.
Enquiries related to non-listed studies (up to 30 September 2022)
A summary of the number of Enquiries received via this site since May 2013 is provided here and is updated every 3 months.
The table below provides information on the number of non-listed studies for which Enquiries were received via ClinicalStudyDataRequest.com. Enquiries received outside the system, general Enquiries not related to accessing patient level data, Enquiries requesting access to documents only and Enquiries for specific data points are not included in these metrics.
1 Study to be listed on ClinicalStudyDataRequest.com and researcher able
to submit a Research Proposal, or access to the requested data is otherwise enabled.
2 Study will not be listed on ClinicalStudyDataRequest.com / access to
data cannot be provided.
Did Not Meet Requirements
The table below provides reasons why Research Proposals have not met the requirements check carried out by Study Sponsors/Funders. More information is usually sought from requestors before the proposal is turned down.
The Research Proposal is not seeking access to anonymised patient level data
| Proposal number |
Sponsor / Funder |
| 615 |
GSK |
| 618 |
GSK |
| 633 |
GSK |
| 690 |
GSK |
| 938 |
BI/GSK/Roche |
| 941 |
Roche |
| 1047 |
GSK |
| 1087 |
GSK |
| 1107 |
GSK |
| 1589 |
Novartis |
The Research Proposal did not meet the Sponsor/Funder policies for informed consent
| Proposal number |
Sponsor / Funder |
| 931 |
BI/GSK |
The Research Proposal required data that was not collected in the studies requested
| Proposal number |
Sponsor / Funder |
| 1552 |
Novartis |
| 1908 |
Lilly |
| 11762 |
Novartis |
The Research Proposal competes with the sponsor's publication plan
| Proposal number |
Sponsor / Funder |
| 1235 |
BI |
| 1245 |
BI |
| 11564 |
Novartis |
| 11904
|
Bayer |
Sponsor doesn't have the legal authority to provide the datas
| Proposal number |
Sponsor / Funder |
| 1751 |
Astellas |
Researcher was directed to Sponsor Clinical Study Reports to find the data requested
| Proposal number |
Sponsor / Funder |
| 5680 |
Lilly |
The product is currently undergoing regulatory activities and data cannot be shared at this time
| Proposal number |
Sponsor / Funder |
| 11480 |
Sanofi |
The image data requested is not in a format that can be easily anonymized
| Proposal number |
Sponsor / Funder |
| 11231 |
Eisai |
Plans are not consistent with the requirement for any model and/or code to be published in a manner that allows their broad non-commercial use
| Proposal number |
Sponsor / Funder |
| 12016 |
GSK |
Novartis will not share case narratives, documentation for adjudication, imaging data (e.g. x-rays, MRI scans, etc.), genetic data and exploratory biomarker data.
| Proposal number |
Sponsor / Funder |
| 1848 |
Novartis |
It is essential for GSK that where GSK data are made available to an academic group to train an AI/ML model, the model
and code are published in a manner that allows their broad non-commercial use. Since your plans are not consistent with this requirement, GSK will not be able to agree to your request.
| Proposal number |
Sponsor / Funder |
| 12032 |
GSK |
| 618 |
GSK |
| 633 |
GSK |
| 690 |
GSK |
| 938 |
BI/GSK/Roche |
| 941 |
Roche |
| 1047 |
GSK |
| 1087 |
GSK |
| 1107 |
GSK |
| 1589 |
Novartis |
| Proposal number
|
Study Sponsor(s)/funder(s)
|
Reason(s)
|
| 615 |
GSK |
The Research Proposal is not seeking access to
anonymised patient level data |
| 618 |
GSK |
The Research Proposal is not seeking access to
anonymised patient level data |
| 633 |
GSK |
The Research Proposal is not seeking access to
anonymised patient level data |
| 690 |
GSK |
The Research Proposal is not seeking access to
anonymised patient level data |
| 931 |
BI/GSK |
The Research Proposal did not meet the Sponsor
policies for informed consent |
| 938 |
BI/GSK/Roche |
The Research Proposal is not seeking access to
anonymised patient level data |
| 941 |
Roche |
The Research Proposal is not seeking access to
anonymised patient level data |
| 1047 |
GSK |
The Research Proposal is not seeking access to
anonymised patient level data |
| 1087 |
GSK |
The Research Proposal is not seeking access to
anonymised patient level data |
| 1107 |
GSK |
The Research Proposal is not seeking access to
anonymised patient level data |
| 1552 |
Novartis |
The proposed research required data that was not collected in the studies requested |
| 1235 |
BI |
The Research Proposal competes with the Sponsor's publication plan |
| 1245 |
BI |
The Research Proposal competes with the Sponsor's publication plan |
| 1589 |
Novartis |
The Research Proposal is not seeking access to anonymised patient level data |
Data Sharing Agreement
A signed Data Sharing Agreement (DSA) is required before data access can be provided.
Through the DSA you agree to:
- Only use the data for the agreed research purpose and not download or transfer the data.
- Protect the privacy and confidentiality of research participants; the researchers must not attempt to establish the individual identities of research participants.
- Obtain any regulatory or ethics approvals necessary to conduct the analysis.
- Notify sponsor of any replacement of Lead Researcher and/or Statistician as approved by the Independent Review Panel.
- Inform the relevant sponsor(s) and regulatory authorities of any safety concerns as soon as they are identified.
- Consent to the posting of the title, research proposal summary, requested clinical studies, the Lead Researcher's name, affiliation, funding source and potential conflicts of interest(as provided on the Research Proposal Form) on ClinicalStudyDataRequest.com, after the Data Sharing Agreement has been signed.
- Publish the results of the analysis in a scientific journal within one year of analysis completion. For failed publications, ensure that any analyses performed and associated outcomes are disclosed in an open access journal or publishing platform, with a link provided on ClinicalStudyDataRequest.com or provide the reason why the analysis was not performed for inclusion on ClinicalStudyDataRequest.com.
- Consent to the posting of the research proposal plan on ClinicalStudyDataRequest.com, after the research is published.
- Provide the relevant sponsor(s) with a copy of any public disclosure of the results, including a copy of the manuscript. (Some sponsors include a provision for prior review of the manuscript; refer to the terms specified in Exhibit E of the actual Data Sharing Agreement.) Also provide the sponsor(s) with the citation after publication.
- Acknowledge the relevant sponsor(s) and ClinicalStudyDataRequest.com in the publication.
- Allow the relevant sponsor(s) to use any invention coming out of the research that impacts the ability of the sponsor to develop or commercialise their products. Such use will be free of charge and throughout the world. If the sponsor requests additional rights, you agree to negotiate in good faith with the sponsor.
- Confirm that you do not have, and do not plan to have, any other agreements which would prevent you from complying with the above.
After approval from the Independent Review Panel, a DSA will be issued by the Sponsor(s) based on the templates provided below.
Your actual DSA may have minor modifications. For example, for a Research Proposal involving multiple Sponsors another DSA similar to the template provided below will be used.
Please note that the Sponsor(s) do not anticipate negotiation on the DSA provisions and it is recommended that the research institution's contracting representatives understand the overall nature of the Research Proposal and conduct an early review of the DSA provisions included in the template(s) provided below, before the actual DSA is issued. Delays due to negotiation will delay data access.
If you are requesting data from a pharmaceutical company the Sponsor Data Sharing Agreement will be used.
Access to Data
Provision of Data
Following receipt of a signed Data Sharing Agreement (DSA), Researchers are provided access to anonymised patient-level data and supporting documentation in a secure data access system, known as the SAS Clinical Trial Data Transparency (CTDT) system. Providing data through this system further safeguards the privacy of patients and helps to ensure that a Researcher's use of the data adheres to the provisions contained within the signed Data Sharing Agreement (DSA). Some Sponsors (e.g. GSK) may provide data directly to Researchers where they are assured that the data will be secure - see the Sponsor specific pages for more information.
Access to data is provided for a 12-month period. Sponsors may extend access when justified for up to 24 months.
About the Clinical Trial Data Transparency (CTDT) System
The CTDT system is hosted by SAS and provides a secure research environment for Researchers to conduct their research.
Research teams are provided with a private research project area containing the anonymised patient level data and supporting documentation where they can create and run programs and store their outputs. This research project area is not accessed by Sponsors or other third parties unless Researchers request support. There are controls in place to prevent Researchers exporting the data and supporting documentation provided by a Sponsor. Researcher's use of the data must adhere to the access and usage conditions required by SAS - SAS Terms of Use.
Pre-installed Statistical Software
Click here to view the statistical software made available to Researchers within the SAS CTDT research environment.
All fees, including licenses, for the pre-installed statistical software indicated above are paid by the Sponsors. The number of licenses for each Research Project may be limited to a maximum of five.
Support
SAS provides technical support to assist Researchers using the CTDT system.
User guides and instructional videos are provided on the CTDT Portal.
In addition, some Sponsors provide support to assist Researchers in understanding the datasets provided. Further information can be found on the Sponsor specific pages.
Public disclosure of the research
After the Data Sharing Agreement is executed the title of the research proposal, name and affiliation of the lead researcher, research proposal summary, requested studies, funding source and potential conflicts of interest that are provided will be posted on this website. The publication citation and statistical analysis plan will be included after the research has been published.
The Data Sharing Agreement includes requirements to disclose the results of the Analysis in a scientific journal in a manner consistent with the research proposal publication plan. If for any reason the Analysis cannot be disclosed in a manner consistent with the publication plan, a brief summary of any activity performed, any outcome of the Analysis, and reason for non-completion, as applicable, should be disclosed in an open access journal or on a publishing platform with a link provided on this website.
All Publications are to acknowledge the appropriate Sponsor(s) and www.ClinicalStudyDataRequest.com as sources of data.
Just a moment, the page is loading...