Clinical WPDs
 WPD 1 – Patient Screening Version 1.0 – Last Updated 20.07.2017 |
WPD 2- Informed Patient Consent Version 1.0 – Last Updated 20.07.2017 |
WPD 3- Patient enrolment and follow-up Version 1.1 – Last Updated 08.07.2018 |
WPD 4- Early patient withdrawal Version 1.0 – Last Updated 20.07.2017 |
WPD 5- Individual study personnel responsibilities Version 1.0 – Last Updated 20.07.2017 |
WPD 6- Contra-indicated drugs Version 1.1 – Last Updated 14.06.2018 |
WPD7- Study Drug Administration Version 1.0 – Last Updated 20.07.2017 |
WPD 8- Toxicity management Version 1.1 – Last Updated 14.06.2018
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WPD 9 – Management of deteriorating patients Version 1.0 – Last Updated 20.07.2017 |
WPD 10- Management of raised ICP Version 1.0 – Last Updated 20.07.2017 |
WPD 11 – Management of patients with recurrent symptoms and possible IRIS Version 1.0 – Last Updated 20.07.2017 |
WPD 12 – Lumbar Puncture Version 1.0 – Last Updated 20.07.2017 |
WPD 13- Inititation of ARVs Version 1.0 – Last Updated 20.07.2017 |
WPD 14 – Protocol violation reporting procedures Version 1.0 – Last Updated 20.07.2017 |
WPD 15 – Timing of clinical evaluation and tests Version 1.0 – Last Updated 20.07.2017 |
WPD 15b – Daily Clinical Review Form Completion Version 1.0 – Last Updated 17.06.2019 |
WPD 16 – ART / Antifungal Interactions Version 1.0 – Last Updated 20.07.2017 |
WPD 17 – ART Exposed Patients Version 1.2 – Last Updated 25.10.2019 |
WPD 18 – ECG Version 1.0 – Last Updated 20.07.2017 |
WPD 19 – PK/PD Sub-study Version 1.0 – Last Updated 20.07.2017 |
WPD 20 – qPCR Sub-study Version 1.0 – Last Updated 21.09.2017 |
WPD 21 – Health Economics Sub-study Version 1.0 – Last Updated 11.01.2018 |
The following posters and documents provide additional guidance:
Patient Screening Version 1.0 – Last Updated 29.06.2018 |
Study Drugs Version 1.1 – Last Updated 13.07.2018 |
Management of Raised ICP Version 1.0 – Last Updated 29.06.2018 |
Telephone Review Form |
Home Visit Form |
Abnormal Blood Values Table |
Visual Acuity Chart |
Review Menu and Adverse Events |
Daily Clinical Review Form |
Dr. David Lawrence’s YouTube channel can be accessed below. In 15 short vidoes David explains how to use the AMBITION Electronic Data Capture Tool (EDC):
