Freedom of Information request on the study protocol, amendments, related study manuals and clinical study report for clinical trial GS-US-174-0149 (FOI 21-732)
Published 29 December 2021
© Crown copyright 2021
This publication is licensed under the terms of the Open Government Licence v3.0 except where otherwise stated. To view this licence, visit nationalarchives.gov.uk/doc/open-government-licence/version/3 or write to the Information Policy Team, The National Archives, Kew, London TW9 4DU, or email: psi@nationalarchives.gov.uk.
Where we have identified any third party copyright information you will need to obtain permission from the copyright holders concerned.
This publication is available at https://www.gov.uk/government/publications/freedom-of-information-responses-from-the-mhra-week-commencing-16-july-2021/freedom-of-information-request-on-the-study-protocol-amendments-related-study-manuals-and-clinical-study-report-for-clinical-trial-gs-us-174-0149-f
16th July 2021
FOI 21/732
Dear
Thank you for your information request, dated 28 June 2021, where you asked for the study protocol, amendments, related study manuals and clinical study report for clinical trial GS-US-174-0149 (ClinicalTrials.gov Identifier: NCT01277601).
I am pleased to provide you with some of the information requested, as listed below.
• Clinical study report for clinical trial GS-US-174-0149 • Protocol Amendment 1; 12 January 2011 • Protocol Amendment 2; 15 April 2011 • Protocol Amendment 3; 02 August 2011 • Protocol Amendment 4.1; Europe; 20 February 2012 • Protocol Amendment 5.1; Europe; 29 June 2012 • Protocol Amendment 6.1; Europe; 17 May 2013
These documents are provided with any personal information or sensitive data redacted.
The study manuals are not provided because they are not regulatory documents and are not submitted to or held by the MHRA.
The Freedom of Information Act only entitles you to access to information – the information supplied is subject to Crown copyright, and there are some restrictions on its re-use. For information on the reproduction or re-use of MHRA information, please visit here
If you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date you receive this response and addressed to: info@mhra.gov.uk .
Please remember to quote the reference number above in any future communications.
If you were to remain dissatisfied with the outcome of the internal review, you would have the right to apply directly to the Information Commissioner for a decision. Please bear in mind that the Information Commissioner will not normally review our handling of your request unless you have first contacted us to conduct an internal review. The Information Commissioner can be contacted at:
Information Commissioner’s Office Wycliffe House Water Lane Wilmslow Cheshire SK9 5AF
Yours sincerely,
MHRA Customer Service Centre
Medicines and Healthcare products Regulatory Agency 10 South Colonnade, Canary Wharf, London E14 4PU Telephone 0203 080 6000