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CSDR Cycle Times for Research Proposals submitted in 2018 (n=97)

WT / Sponsor Checks
Mean 1.6 months
IRP Review
Mean 1 month
DSA Review and Sign Off *  
Mean 3.6 months
Data/Document Preparation
Mean 0.8 months
Median 1.4 months
Range 0-8 months
Median 0.9 months
Range 0-4 months
Median 2.9 months
Range 0-11.4 months
Median 0.5 months
Range 0-4 months
Submission to Data Access Provided (n=46)
Mean 6.4 months, Median 6.3 months, Range 1.7-15.7 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
WT = Wellcome Trust 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 31 January 2020)

The total number of studies listed on this site is 3123.

Research Proposals requesting access to patient level data (up to 31 December 2019)

A summary of the number of Research Proposals received via this site since May 2013 is provided here and is updated 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.

Number of Research Proposals submitted up to 31 December 2019 564
Requirements check In process 28
Withdrawn by the requestor 51
No response received 24
Did not meet requirements (further details) 23
Potential conflict of interest or an actual or potential competitive risk 0
Met requirements 437
IRP review In process 6
Withdrawn by the requestor 4
No response received 2
Rejected or advised to re-submit 64
Approved or approved with conditions 361
Data Sharing Agreement In process 39
Withdrawn by the requestor 19
No response received 11
Not agreed by requestor 2
Agreed (signed) View details of these Research Proposals 290
Data preparation In process 11
Withdrawn by the requestor 1
No response received 2
Complete (data available) 276
Data Access Access provided 149
Withdrawn by the requestor 3
Access closed 124
Publication anticipated 29
View details of these Research Proposals
Withdrawn by requestor 13
No response received 20
Publication not received after 18 months of Access Closed 13

Multi-Sponsor Research Proposals were possible starting 1 January 2014. Out of 564 proposals submitted since 1 January 2014, 87 were multi-Sponsor proposals.

Enquiries related to non-listed studies (up to 31 December 2019)

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.

Study Sponsor/Funder Number of non-listed studies requested Number of studies undergoing feasibility assessments Number of studies with a positive response1 Number of studies with a negative response2
Astellas 59 10 9 48 (further details)
Boehringer Ingelheim 74 0 43 31 (further details)
Daiichi Sankyo 2 1 0 2 (further details)
Eisai 67 0 6 61 (further details)
GSK 286 1 212 72 (further details)
Lilly 205 0 92 113 (further details)
Novartis 253 11 69 173 (further details)
Roche1 206 11 53 142 (further details)
Sanofi 128 11 24 93 (further details)
Takeda 100 0 23 77 (further details)
UCB 41 6 28 31 (further details)
ViiV Healthcare 8 0 8 0

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.