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Procedures

WWARN is continually updating a library of standardised procedures that offer guidance in the execution of various activities in the fields of clinical, in vitro, pharmacology, data collection and molecular analysis for antimalarial drug resistance researchers. Please read our tools and resources usage guidance.

For resources that relate to other infectious and emerging diseases, visit iddo.org.

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CL02
Digital measurement of axillary temperature
A process for measurement and recording of axillary body temperature of participants enrolled in malaria drug trials
Version: 2.0 Author: WWARN
CL01
Measuring temperature by ThermoScan
A procedure for measurement/recording of tympanic membrane temperature using the Braun ThermoScan in participants enrolled in malaria drug trials
Version: 2.0 Author: WWARN
CL03
Collection of ECG data in antimalarial clinical trials
A general process for collecting the standard 12-lead clinical trial ECG data, to support any trial-specific instructions
Version: 1.2 Author: WWARN, Banook Group & LSTM
Data management tables for standard efficacy analysis
These are template database tables for use in a typical malaria efficacy trial analysis
Version: v2.0 Author: WWARN
PHA_DM03
Master validation plan
For listing and documenting the objectives for all parties responsible for validation of computer equipment and software for a clinical trial
Version: v1.0 Author: WWARN
DMSTAT04
Serious adverse event data reconciliation
For when there is a need to reconcile safety data that are stored in two different databases during a clinical trial
Version: 2.0 Author: WWARN
DMSTAT01
Data management protocol generic
Instruction to those data management team members delegated responsibility for producing and working on a data management protocol
Version: 2.0 Author: WWARN
Malaria Case Record Form (CRF)
Malaria Clinical Trial Case Record Form
Version: 2.0 Author: WWARN
QA01
Quality management plan (clinical conduct)
A system for applying quality management at the trial site so there is effective compliance with sponsor, applicable regulatory and ethical requirements
Version: 2.0 Author: WWARN
QA08
On-site monitoring
For when an investigator/institution takes responsibility for on-site monitoring of a clinical trial
Version: 2.0 Author: WWARN

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