Triple Antiplatelets for Reducing Dependency after Ischaemic Stroke (TARDIS) trial
Investigator Materials
Urgent contact information
The TARDIS Trials Office can be contacted in UK working hours (excluding weekends and public holidays) on: +44 115 823 1770
For urgent medical enquiries related to the trial (including unblinding) or randomisation problems (including website failure requiring manual randomisation), please contact the following emergency mobile numbers in the order shown:
- +44 (0)7798 670726
- +44 (0)7725 580092
- +44 (0)7760 882925
If you have specific questions about the trial, try reviewing the Training PowerPoint presentation and the FAQ page (see immediately below scrolling text).
The National Institute for Health Research (NIHR) is highlighting TARDIS (link) as part of its Focus on Stroke initiative.
Helpful Resources
FAQ, v1.5 (WPD 002) (pdf)
Training Presentation, V1.5 (ppt) For those using protocol Version 1.5
Training Presentation, V1.4 (ppt) For those using protocol Version 1.4
Training Presentation, V1.3 (ppt) For those using protocol Version 1.3
Documents
Feel free to download the following TARDIS documents as and when required. The data collection forms may be completed and then faxed to the Trials Office if you are not using the website for entering data. These documents are not designed for use outside the TARDIS trial or by people who are not investigators in the TARDIS trial. Where documents are ordered, they are usually either alphabetical or by ascending date.
NEW DOCUMENTS
The following are new or updated documents. They can also be found under the headings below but are located here for ease of reference. Letters etc. are now only being uploaded as .docs because they need to have logos etc. added which is not usually possible in a .pdf. You may find it useful to make a .doc into a .pdf once you have added any logos, phone numbers etc: your IT helpdesk will be able to assist with this.
Blood sample collection (WPD 046) v1.0 (pdf)
On UK-specific page:
09/02/2015, acceptance from REC (pdf)
07/08/2014, substantial amendment application form and cover letter (pdf)
All Documents
Contents
Click on the links to be taken to the corresponding section.
Country-specific Pages
United Kingdom
România (Romania)
sakartvelo (Georgia)
Danmark (Denmark)
New Zealand
Australia
General
Expression of Interest form v1.4 (pdf)
List of Contacts v3.3 (pdf) **UPDATED**
Flow chart v1.5 (pdf) For those using protocol version 1.3
Flow chart v1.4 (pdf) For those using protocol version 1.2
Timeline v1.0 (pdf)
Investigators' Brochure, v1.0 (pdf)
Closedown Documents
Declaration of End of Study dated 08/06/2016 (pdf)
MHRA End of Trial Acknowledgement dated 04/05/2016 (pdf)
HRA SA03/16 Favourable Opinion dated 01/04/2016 (pdf)
HRA SA03/16 Acknowledgement from HRA dated 30/03/2016 (pdf)
Closedown (WPD 040) v2.2 dated 23/01/2017 (pdf)
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Sponsor Standard Operating Procedures (SOPs)
The Sponsor (University of Nottingham) maintains comprehensive 'high-level' generic trial SOPs - please email tardis@nottingham.ac.uk if you need further information. The following are particularly relevant:
SOP TA008: Trial Initiation v2.5 (pdf)
SOP TA009: CRF Design V1.0 (pdf)
SOP TA010: Trial Master File and Trial Site File V1.5 (pdf)
SOP TA011: Participant Recruitment and Consent V1.0 (pdf)
SOP TA012: Trial Monitoring V1.0 (pdf)
SOP TA013: Protocol Amendments V3.0 (pdf)
SOP TA014: Serious Adverse Event (SAE) Reporting V2.5 (pdf)
SOP TA015: Trial Closure V1.5 (pdf)
SOP TA016: Serious GCP Breach Reporting V1.0 (pdf)
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Working Practice Documents (WPDs)
FAQ, v1.5 (WPD 002) (pdf)
Computer disaster recovery plan (WPD 003) v1.1 (pdf)
Completion, Baseline form (WPD 004) v1.2 (pdf)
Completion, Hospital events form (WPD 006) v1.2, refers to form v1.6 (pdf)
Outcome & SAE recording (WPD 007) v2.2 (pdf)
Day 90 Follow-Up (WPD 009) (pdf) v1.0, 21/05/2015 **NEW**
Start-up a UK site (WPD 011) v1.0 (pdf)
Emergency randomisation (WPD 015) v1.3 (pdf)
Substudy, TCD (WPD 018) v1.0 (pdf)
Change site PI (WPD 021) v1.0 (pdf)
Site monitoring (WPD 022) v1.2 (pdf)
Posting CT/MR scans (WPD 025) v1.0 (pdf)
Trial Steering Committee (WPD 027) v1.3 (pdf)
Blood collection & storage (WPD 029) v1.2 (pdf)
Version control (WPD 031) v1.0 (pdf)
Risk assessment (WPD 032) v1.1 (pdf)
Source documentation (WPD 033) v1.0 (pdf)
Additional brain scanning (WPD 034) v1.0 (pdf)
Patient Scans: what is required and where to send them (WPD 035) v1.1 (pdf)
Uploading scans to the website (WPD 035a) v1.1 (pdf)
Finding images to upload (WPD 035b) v1.0 (pdf)
Finding images to upload (WPD 035b) v1.0 (PowerPoint slideshow)
Change password (WPD 036) v1.0 (pdf)
Closedown (WPD 040) v2.2 (pdf)
Safety Monitoring (WPD 043) v1.0 (pdf)
Statistical programming (WPD 044) v1.0 (pdf)
SAE Bleeds (WPD 045) v1.0 (pdf)
Blood sample collection (WPD 046) v1.0 (pdf)
Day 90 Data Checks (WPD 047) v1.0 (pdf) **NEW**
SAE categories (WPD) (link) You will need to log in to TARDIS to see this file
GCP training (WPD) v1.0 (pdf)
Protocol Violations (WPD) v1.2 (pdf)
Imaging form, v1.2 (pdf)
Fax: safe haven, 09/04/2008 (pdf) from the University of Nottingham
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Data collection
Patient details form, v1.5 (pdf)
eCRF blank forms (link) You will need to log in to TARDIS to see these documents
Logs
Blood sample freezer log, v1.0 (pdf)
Pharmacy
Pharmacy - Dispensing procedure (example), v3.1 (doc)
Pharmacy - Labels, v2.2 (doc)
Pharmacy - Drug Accountability Log v1.1 (doc)
Pharmacy - Prescription v2.1 (doc)
From Sponsor
Screening & enrolment log (RF1 TA011), v1.0 (doc) Fields can now be filled in electronically
Delegation Log (RF2 TA008), v1.0 (doc) Fields can now be filled in electronically; delegated duties attached
Training record form (RF1 TA008), v1.0 (doc) Fields can now be filled in electronically
Other forms
CV template and completion guidance (doc)
Fax cover sheet, v1.3 (pdf)
Randomisation choices form, v1.1 (pdf)
File note form, v1.2 (pdf)
File note form, v1.2 (doc)
Looking for a form but can't find it? Try looking on the eCRFs page (you will need to login to TARDIS)
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Ethics approved documents
Forms, letters and information sheets are now being supplied as .doc only as you need to add your Trust logo and relevant contact names & telephone numbers where required.
Consent Forms
Patient Consent v1.5 (doc)
Relative Consent Form v1.5 (doc)
Patient Consent Form following Relative Proxy Consent v1.5 (doc)
Genetic substudy consent v1.5 (doc)
Independent Physician consent v1.5 (doc)
Information Sheets
Patient Information Sheet v1.5 (doc)
Relative information sheet v1.5 (doc)
Information Sheet for patients with relative consent v1.5 (doc)
Independent Physician information sheet v1.5 (doc)
Letters
GP letter v1.3a (doc)
Protocols and related documents
Protocol v1.5 (pdf)
Protocol v1.5, signature page (pdf)
Protocol changes, v1.4 to 1.5 (pdf)
Protocol v1.4 (pdf)
Protocol v1.4, signature page (pdf)
Protocol changes, v1.3 to v1.4 (pdf)
Protocol, v1.3 (pdf)
Protocol v1.3, signature page (pdf)
Protocol changes, v1.2 to 1.3 (pdf)
Protocol, v1.2 (pdf)
Protocol changes, v1.1 to 1.2 (pdf)
Supporting documents
CV for Philip Bath, 18/01/2013 (pdf)
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If you are looking for country-specific documents, these have been moved: please go to the relevant country-specific page
Miscellaneous
TARDIS synopsis v1.0 (pdf)
NIHR highlight TARDIS (link) as part of its Focus on Stroke initiative, February 2014
CHANCE: TARDIS TSC and DMC recommendation (pdf), 1st August 2013
HTA funding letter, 22/05/2012 (pdf)
BHF funding letter, 18/8/2008 (pdf)
NUH NHS Trust, Caldicott policy, 08/04/2009 (pdf)
SRN adoption letter, 11/03/2009 (pdf)
EudraCT email, 28/07/2008 (pdf), confirmation of application for EudraCT number
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Data Monitoring Committee
Data Monitoring Committee Reports
18 March 2016 (pdf)
17 September 2015 (pdf)
30 January 2015 (pdf)
24 September 2014 (pdf)
22 March 2014 (pdf)
02 December 2013 (pdf)
15 May 2013 (pdf)
01 December 2012 (pdf)
09 May 2012 (pdf)
28 November 2011 (pdf)
06 June 2011 (pdf)
29 November 2010 (pdf)
15 June 2010 (pdf)
Data Monitoring Committee Charter
DMC Charter, V1.2 (pdf)
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Trial Steering Committee
Trial Steering Committee Charter, v1.6 (pdf) February 2014
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Publications
The following .pdf files describe studies underpinning TARDIS. These are for the local use of investigators; please do not distribute the files since their copyright is held by the publishers in some cases.
TARDIS trial protocol (2015) (pdf)
'Triple 2' trial - Triple antiplatelets versus aspirin (2008) (pdf)
'Triple 1' trial - Triple, dual and mono antiplatelets - soluble markers (2006) (pdf)
'Triple 1' trial - Triple, dual and mono antiplatelets - platelets (2005) (pdf)
'Triple' case series - Triple antiplatelets, long term (2004) (pdf)
Laboratory - Triple antiplatelets (2003) (pdf)
Laboratory - Triple antiplatelets (2001) (pdf)
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Presentations
SRN - Thames meeting, 23 September 2011 (ppt)
Sri Lanka - Background talk, March 2010 (Columbo) (ppt)
Scottish SRN Investigator meeting, October 2009 (Glasgow) (ppt)
UK Investigator meetings (Nottingham):
UK Investigator meeting - Nottingham, 14-15 September 2015 (pptx, 60Mb) This file is very large: it may take up to 5mins to download on a broadband connection. The individual presentations can be downloaded separately (see below)
TARDIS Status Update, 14 September 2015 (pptx)
TARDIS parallel session, 14 September 2015 (pptx)
Monitoring and Site Files, 14 September 2015 (pptx)
Recruitment Practicalities (parallel session), 15 September 2015 (pptx)
SAE Reporting, 15 September 2015 (pptx)
Neuroimaging, 15 September 2015 (pptx, 10Mb) This file is quite large: it may take up to 1min to download on a broadband connection
Brain Scans, 15 September 2015 (pptx)
UK Investigator meeting - Nottingham, 17-18 April 2013 (ppt, 37Mb) This file is very large: it may take up to 3mins to download on a broadband connection
UK Investigator teleconference, 24th May 2013 (pdf)
UK Investigator meeting, 6 September 2011 - Joint TARDIS, ENOS & PODCAST (ppt)
UK Investigator teleconference, 18 June 2010 (pdf)
UK Investigator teleconference, March 2010 (pdf)
TARDIS slide set, March 2010 (ppt): Now .ppt format to avoid compatibility issues
TARDIS Platelet substudy introduction (March 2009) (ppt)
TARDIS Platelet substudy vacutainer animation (May 2015) (pps) Opens as a slideshow
TARDIS TCD substudy (March 2009) (ppt)
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Demo/practice website and database
Enter demo/practice TARDIS trial web-site
Log-in details
Investigator ID: demoinv1
Password: nottingham
PIN: 8888
Please note that data entered into the demo/practice website and database is not entered into the main/full trial database and does not contribute to trial data. However, this website and database replicates and demonstrates the functions of the main trial website and database.
For International Coordinating Centre / Nottingham Trial Office
University of Nottingham 'high level' SOPs (link) - only available within UoN intranet
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, 13 September 2017
