Protocol and Trial Manual
Protocol Version 3.0 07-Oct-2014
Trial Manual Draft Version 15-Apr-2014 (Remains in DRAFT until activation)
IMP Documents
Dexsol® 2mg/5ml Oral Solution SmPC Date of revision of text: 12-Apr-2013
To Take Out (TTO) Medication Instructions Version 1.0 23-Jul-2013
Patient Information and Consent
Patient Information Leaflet Version 2.0 11-Feb-2014
Personal Legal Representative Information Leaflet Version 2.0 11-Feb-2014
Patient Information Sheet and Consent Form Version 1.0 11-Feb-2014
Personal Legal Representative Information Sheet and Consent Form Version 1.0 11-Feb-2014
Case Record Form and Questionnaires
Patient Follow-up Questionnaire Version 1.0 23-Jul-2013
Relative Follow-up Questionnaire Version 1.0 23-Jul-2013
Case Record Form Version 1.0 31-mar-2014
Case Record Form Completion Guidelines Version 1.0 07-Oct-2014
Safety Reporting Documents
ASAP Initial SAE form Version 2.0 02 June 2017
ASAP Follow-Up SAE form Version 2.0 02 June 2017
Pharmacy Documentation
Pharmacy Manual Draft Version 1.7 08-Apr-2014 (Remains in DRAFT until activation)
IMP Inventory Log Draft Version 10-Mar-2014 (Remains in DRAFT until activation)
IMP Destruction Log Draft Version 10-Mar-2014 (Remains in DRAFT until activation)
Other Documentation
Site Visit Log Version 1.0 20-Feb-2014
GP letter Version 1.0 23-Oct-2013
Participant Identification Log Version 1.0 20-Feb-2014
Confidential Contact Information Sheet Version 1.0 18-Mar-2014
Patient Transfer Pack Version 1.0 15-Aug-2017
Sub-Study Documentation
This documentation is only applicable to the following sites:
- Aintree University Hospital, Liverpool
- City Hospital, Nottingham
- Manchester Royal Infirmary
- Queen’s Medical Centre, Nottingham
- Royal Liverpool University Hospital
- Southampton General Hospital
ASAP Sub-Study Laboratory Manual Version 1.0 18-Aug-2017
ASAP Sub-study patient consent form version 1.0 14-Oct-2014
ASAP Sub-study PLR consent form version 1.0 14-Oct-2014
Mechanistic sub-study Patient Information Sheet Version 1.0 14-Oct-2014
Mechanistic sub-study PLR Information Sheet Version 1.0 14-Oct-14
This page was last updated on April 1st, 2015 at 1:14 pm
