Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke (TARDIS) trial

Investigator Materials: United Kingdom

Contents

Click on the links to be taken to the corresponding section.

Amendments and Requests

SA01/16 site and PI changes

SA01/15 site and PI changes
SA05/14 site and PI changes
SA04/14 site and PI changes
Minor amendment to GP letter April 2014
Protocol v1.5 (SA03/14)
SA02/14 site and PI changes
SA01/14 changes to and new GP and patient letters
SA05/13 site and PI changes
SA04/13 site and PI changes
SA03/13 site and PI changes
SA02/13 site and PI changes
Protocol v1.4 (SA01/13)
SA01/13 site and PI changes
SA02/12 site and PI changes
SA01/12 site and PI changes
Protocol v1.3 (SA06/11)
SA05/11 site and PI changes; increase recruitment to 1000 participants and extend trial by 7 months
SA04/11 site and PI changes
SA03/11 site and PI changes
SA02/11 site and PI changes
SA01/11 site and PI changes
SA06/10 site and PI changes
SA05/10 site and PI changes
SA04/10 site and PI changes
Minor amendment to 90-day follow-up June 2010
SA03/10 site and PI changes
SA02/10 site and PI changes
SA01/10 site and PI changes
SA01/09 site and PI changes
SA July 09 site and PI changes
Protocol v1.2 no SA number issued, request dated May 2009
April 09 site and PI changes
March 09 site and PI changes
Initial Trial Approvals, inc. Protocol v1.1 no SA number issued, request dated August 2008

Sponsor documents
Insurances etc. from the University of Nottingham

Amendments and Requests

SA01/16

09/02/2015, acceptance from REC (pdf)
07/08/2014, substantial amendment application form and cover letter (pdf)

SA03/15

14/08/2015, acceptance from REC (pdf)
07/08/2014, substantial amendment application form and cover letter (pdf)

SA02/15

16/06/2015, acceptance from REC (pdf)
16/06/2014, substantial amendment application form and cover letter (pdf)

SA01/15

14/04/2015, acceptance from REC (pdf)

SA05/14

06/11/2014, acceptance from REC (pdf)
01/10/2014, substantial amendment application form and cover email (pdf)

SA04/14

23/07/2014, acceptance from MREC (pdf)
23/07/2014, substantial amendment application form and cover letter (pdf)

Minor amendment to GP letter

29/05/2014, acknowledgement from Sponsor (pdf)
22/04/2014, acknowledgement from MREC (pdf) re-issue
22/04/2014, acknowledgement from MREC (pdf)

Protocol v1.5 (SA03/14)

14/04/2014, acceptance from MHRA (pdf)
22/04/2014, acceptance from MREC (pdf)
22/04/2014, acknowledgement from MREC (pdf)
28/03/2014, acknowledgement from MHRA (pdf)
11/03/2014, substantial amendment application form and cover letter (pdf)

SA02/14

17/04/2014, acknowledgement from MREC (pdf) re-issued 17/04/2014
17/04/2014, acknowledgement from MREC (pdf)
11/03/2014, substantial amendment application form and cover letter (pdf)

SA01/14

19/02/2014, acknowledgement from MREC (pdf) re-issue
18/02/2014, acknowledgement from MREC (pdf) re-issue: no amendment code included in letter
10/02/2014, acknowledgement from MREC (pdf) GP letters version numbers incorrect; see above
14/02/2014, response from MHRA (pdf) 'SA01/14' is not a substantial amendment
31/01/2014, (substantial) amendment application form and cover letter (pdf)

SA05/13

29/01/2014, acknlowledgement from MREC (pdf)
17/12/2013, substantial amendment application form and cover letter (pdf)

SA04/13

21/10/2013, acknowledgement from MREC (pdf)
08/10/2013, substantial amendment application form and cover letter (pdf)

SA03/13

12/03/2014, acknowledgement from MREC (pdf) re-issue
21/10/2013, acknowledgement from MREC (pdf)
02/08/2013, substantial amendment application form and cover letter (pdf)

SA02/13

12/07/2013, acknowledgement from MREC (pdf)re-issue
04/07/2013, acknowledgement from MREC (pdf)
04/06/2013, acknowledgement from MREC (pdf)
21/05/2013, acknowledgement from MREC (pdf)
30/04/2013, substantial amendment application form (pdf)

Protocol v1.4 (SA01/13)

28/06/2013, acknowledgement from MREC (pdf) re-issue

03/05/2013, acceptance from MHRA (pdf)
29/04/2013, acknowledgement from MREC (pdf)
26/03/2012, substantial amendment application (pdf)
26/03/2012, substantial amendment application signature page (pdf)
05/03/2013, signed CT application (pdf)
27/02/2013, request letter to MHRA (pdf)
27/02/2013, request letter to MREC (pdf)

SA01/13

06/03/2013, acknowledgement from MREC (pdf)
01/03/2012, acknowledgement from MREC (pdf)
21/12/2012, substantial amendment application form and cover letter (pdf)

SA03/12

06/03/2012, acknowledgement from MREC (pdf)

SA02/12

11/06/2012 acknowledgement from MREC (pdf)

SA01/12

06/06/2012, acknowledgement from MREC (pdf)

Protocol v1.3 (SA06/11)

28/06/2013, acknowledgement from MREC (pdf) re-issue
06/09/2012, acknowledgement from MREC (pdf) re-issue
03/09/2012, acknowledgement from MREC (pdf) re-issue
03/05/2012, acknowledgement from MREC (pdf) re-issue
22/12/2011, substantial amendment application, cover letter and MRHA acceptance (pdf)
22/12/2011, substantial amendment application, cover letter and MREC acknowledgement (pdf)
20/12/2011, CT application form, protocol summary changes and complete protocol (pdf)
20/12/2011, application form to and acceptance from MHRA (pdf)
25/11/2011, application form to and acknowledgement from MREC (pdf)

SA05/11

31/01/2012, acceptance from MHRA (pdf)

SA04/11

30/11/2011, acknowledgement from MREC (pdf)

SA03/11

18/10/2011, acceptance from MHRA (pdf)

SA02/11

08/09/2011, acknowledgement from MREC (pdf)

SA01/11

14/03/2011, acknowledgement from MREC (pdf)

SA06/10

08/12/2010, acknowledgement from MREC (pdf)

SA05/10

05/11/2010, acknowledgement from MREC (pdf)
19/10/2010, acceptance from MHRA (pdf)

SA04/10

21/10/2010, acknowledgement from MREC (pdf)
08/09/2010, acceptance from MHRA (pdf)

Minor amendment to 90-day follow-up

24/06/2010, acknowledgement from MREC, 24/06/2010 (pdf)

SA03/10

07/06/2010, acknowledgement from MREC (pdf)

SA02/10

20/05/2010, acknowledgement from MREC (pdf)
18/05/2010, acceptance from MHRA (pdf)

SA01/10

29/03/2010, acknowledgement from MREC (pdf)
22/03/2010, acceptance from MHRA (pdf)

SA02/09

29/10/2009, acknowledgement from MREC (pdf)

SA01/09

29/09/2009, acknowledgement from MREC (pdf)
16/09/2009, acceptance from MHRA (pdf)

SA July 09

27/07/2009, acknowledgement from MREC (pdf)
23/07/2009, acceptance from MHRA (pdf)

Protocol v1.2 (no SA number issued)

08/07/2009, acceptance from MHRA (pdf)
16/06/2009, acknowledgement from MREC (pdf)
09/06/2009, acceptance from MHRA (pdf)
22/05/2009, application to MHRA (pdf)
22/05/2009, addendum to application to MHRA (pdf)
22/05/2009, covering letter to MREC (pdf)

April 09

16/04/2009, acceptance from MHRA (pdf)

March 09

23/03/2009, acceptance from MHRA (pdf)

Initial Trial Approvals, inc. Protocol v1.1 (no SA number issued)

09/01/2009, acknowledgement from MREC, (pdf)
22/12/2008, response to MREC letter dated 01/12/2008 (pdf)
01/12/2008, response to MREC letters dated 12/11/2008 & 19/11/2008 (pdf)
21/10/2008, CTIMP application form to MREC (pdf)
17/10/2008, acceptance from MHRA (pdf) Note: this refers to all three antiplatelets, not just aspirin as suggested in the letter
14/10/2008, letter from MREC requesting further clarification (pdf)
13/08/2008, application form to MHRA (pdf)
12/08/2008, application form to NHS (M)REC (pdf)

UoN, HTA policy, 24/08/2006 (pdf)
UoN, Annual insurance cover letter for UK 1 Aug 2017 - 31 July 2018, dated 25/07/2017 (pdf)
UoN, Annual insurance cover letter for UK 1 Aug 2016 - 31 July 2017, dated 20/07/2016 (pdf)
UoN, Annual insurance cover letter for UK 1 Aug 2015 - 31 July 2016, dated 21/07/2015 (pdf)
UoN, Annual insurance cover letter for UK 1 Aug 2014 - 31 July 2015, dated 29/07/2014 (pdf)
UoN, Annual insurance cover letter for UK 1 Aug 2013 - 31 July 2014, dated 31/07/2013 (pdf)
UoN, Annual insurance cover letter for UK 1 Aug 2012 - 31 July 2013, dated 25/07/2012 (pdf)
UoN, Annual insurance cover letter for UK 1 Aug 2011 - 31 July 2012, dated 26/07/2011 (pdf)
UoN, Annual insurance cover letter for UK 1 Aug 2010 - 31 July 2011, dated 22/07/2010 (pdf)
UoN, Annual insurance cover letter for UK 1 Aug 2009 - 31 July 2010, dated 28/07/2009 (pdf)
UoN, Sponsor's approval letter to MREC, 22/10/2008 (pdf)
UoN, Sponsor's approval letter to MHRA, 13/08/2008 (pdf)
UoN, Annual insurance cover letter for UK 1 Aug 2008 - 31 July 2009, 18/08/2008 (pdf)

Contact details

TARDIS Trial Office

Stroke, Division of Clinical Neuroscience

University of Nottingham

Clinical Sciences Building

City Hospital Campus

Hucknall Road

Nottingham

NG5 1PB

UK

Telephone: +44 115 823 1770

Fax: +44 115 823 1771

E-mail: tardis@nottingham.ac.uk

Written by Philip Bath, last update by Mark Sampson, 13th September 2017