Trial Documentation

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:

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


This project was funded by the National Institute for Health Research Health Technology Assessment Programme (project number 12/127/10). Trial Identifier: ISRCTN72331452. EudraCT Number: 2013-001051-12.