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Procédures

Ces procédures sont des documents pertinents et robustes qui fournissent des instructions détaillées sur la façon de mener les tests, d'enregistrer les observations utilisées pour examiner les réponses du malade ou du parasite aux antipaludiques et de recueillir les données.

L'utilisation de procédures standardisées facilite la comparaison intra et interrégionale des résultats. A cet effet, WWARN développe, à l'attention des chercheurs travaillant sur la résistance aux antipaludiques, une bibliothèque de procédures standardisées qui guident l'exécution de diverses tâches dans les domaines de l'analyse clinique, in vitro, pharmacologique et moléculaire. 

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WWARN Malaria Data Dictionary
Understand the data variables in data files
Version: 1.0 Author: Kalynn Kennon
PHA10
WWARN Antimalarial – Lumefantrine POP/PK Study Group NONMEM codes 1 & 2
NONMEM code for Antimalarial – Lumefantrine POP/PK Study Group
Version: 1 Author: Junjie Ding & Joel Tarning
PHA09
WWARN Piperaquine PK PD Study Group NONMEM code
NONMEM code for Piperaquine PK/PD Study Group
Version: 1 Author: Junjie Ding & Joel Tarning
AD13
Communicating end of trial results to participants
A suggested process for communicating end of trial results to people who took part in a typical antimalarial drug trial
Version: v1.0 Author: WWARN
SAF01
Safety assessment and reporting
A process for the identification, management, assessment, and reporting of adverse events/adverse drug reactions
Version: v1.0 Author: WWARN
CL08
Management of acute hemolysis (primaquine for P vivax)
An approach to managing suspected haemolysis in participants taking part in trials using primaquine for P vivax infection
Version: 1.0 Author: IMPROV trial group
CL07
Late antimalarial treatment failure
A process for case management of patients with uncomplicated malaria who fail first line treatment in antimalarial drug field trials
Version: 1.0 Author: CCOAT
CL06
Management of hyperparasitaemia
A process for case management of patients with hyperparasitaemia in field malaria drug trials
Version: 1.0 Author: CCOAT
CL05
Measuring respiratory rate
A process for measuring and recording respiratory rate in participants enrolled in an antimalarial drug trial
Version: 2.0 Author: WWARN
CL04
Measuring body weight
A process for calibrating scales, measuring and recording weight of participants enrolled in malaria drug trials
Version: 2.0 Author: WWARN

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