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QA08
On-site monitoring
Procedure
For when an investigator/institution takes responsibility for on-site monitoring of a clinical trial
Version: 2.0 Author: WWARN
SAF01
Safety assessment and reporting
Procedure
A process for the identification, management, assessment, and reporting of adverse events/adverse drug reactions
Version: v1.0 Author: WWARN
EXT05
msp1 PCR
Procedure
PCR amplification of the polymorphic marker msp1 to distinguish recrudescences from reinfections
Version: 1.0 Author: Mekong Molecular Surveillance Network
MOL08
PCR and sequencing for genotyping of candidate Plasmodium falciparum artemisinin resistance SNPs in the Kelch 13 gene
Procedure
Genotyping of SNPs in the Kelch 13 gene (PF3D7_1343700), associated with artemisinin resistance
Version: 1.0 Author: D. Menard & F. Ariey Institut Pasteur
MOL04
Quantification of Human and P. Falciparum DNA
Procedure
Estimating Plasmodium falciparum and human DNA concentration in infected blood samples by fluorometer and real-time PCR
Version: v1.0 Author: WWARN
EXT02
DNA extraction by Chelex
Procedure
Extracting Plasmodium spp. DNA from dried blood spots by Chelex 100
Version: 1.0 Author: Mekong Molecular Surveillance Network
INV01
Culture of Plasmodium falciparum blood stages
Procedure
Methods for short- and long term culture of Plasmodium falciparum laboratory strains and fresh isolates
Version: v1.0 Author: WWARN
INV10
Ring-stage Survival Assays (RSA) to Evaluate the In-Vitro and Ex-Vivo Susceptibility of Plasmodium Falciparum to Artemisinins
Procedure
Evaluting Plasmodium falciparum susceptibility to artemisinins in laboratory strains and fresh isolates
Version: v1.2 Author: Institut Pasteur du Cambodge & National Institute of Allergy and Infectious Diseases/NIH
INV09
Estimation of Plasmodium falciparum drug susceptibility ex vivo by HRP2 ELISA
Procedure
Drug susceptibility assay measuring histidine-rich protein production by ELISA in fresh isolates
Version: v1.0 Author: WWARN
INV02
Preparation of Culture Medium
Procedure
Preparing complete medium for Plasmodium falciparum cultures
Version: v1.1 Author: WWARN

Pages

116 results

Site handling of monitoring visits

procedure

On-site monitoring

procedure

Communicating end of trial results to participants

procedure

glurp PCR

procedure

WWARN Explorer

visualisation

ACT Partner Drug Molecular Surveyor

visualisation

Methods and techniques for assessing exposure to antimalarial drugs in clinical field studies

publication

SP Molecular Surveyor

visualisation

Artemisinin Molecular Surveyor

visualisation

P. vivax Drug Efficacy: Protocol Template

document

Central receipt of investigational product

procedure

Packaging and labeling investigational products/study drugs

procedure

Dispensing, dosing and return of investigational product/study drug

procedure

Disposal of investigational products/study drugs

procedure

Randomisation and blinding

procedure

General evacuation of the clinical trial facility

procedure

Evacuating a patient in the event of a medical emergency

procedure

Post-exposure prophylaxis in the clinical trial facility

procedure

Emergency scenario training for clinical trial facilities

procedure

Medical emergencies at field trial sites

procedure

Trial risk assessment (by the site)

procedure

Safety assessment and reporting

procedure

Set up and maintenance of the Investigator Site File

procedure

Organising trial initiation meetings

procedure

Trial staff training

procedure

Identifying critical suppliers of trial services

procedure

Clinical trial project management

procedure

Standard operating procedure management

procedure

Non compliance

procedure

Pre-trial site assessment

procedure

Set up and maintenance of the Sponsor File

procedure

Quality management plan (clinical conduct)

procedure

General preparation for clinical trial conduct

procedure

Preparing for scheduled trial admission periods

procedure

Pre- and post-admission team meetings

procedure

Data recording by clinical trial staff

procedure

Clinical conduct of scheduled admission periods

procedure

Data management tables for standard efficacy analysis

procedure

Patient Book Extract

document

In Vitro Sample Study Report

document

Archiving of clinical trial Essential Documents

procedure

WHO Template protocol for therapeutic efficacy studies

document

Informed consent

procedure

Database construction, security, backup, close and lock

procedure

Data receipt, entry and validation

procedure

Clinical Data Management and Analysis Plan

document

In Vitro Data Management and Statistical Analysis Plan

document

Pharmacology Data Management and Statistical Analysis Plan

document

Molecular Data Management and Statistical Analysis Plan

document

First malaria therapeutic area data standard (TAUG-malaria)

page

Malaria Case Record Form (CRF)

procedure

Data management protocol generic

procedure

Serious adverse event data reconciliation

procedure

Master validation plan

procedure

Building an electronic data management system using the WWARN annotated Case Record Form

document

WWARN Malaria Data Dictionary

procedure

IVART

visualisation

IVART Methodology

page

Parasite Clearance Estimator (PCE)

visualisation

Introduction to PK Analysis & Population Pharmacometrics

visualisation

IVART data template

document

IVART example tagging

document

IVART step-by-step guide

document

Obare Method Calculator

visualisation

The Obare Method Calculator

document

WWARN Piperaquine PK PD Study Group NONMEM code

procedure

WWARN Antimalarial – Lumefantrine POP/PK Study Group NONMEM codes 1 & 2

procedure

Screening visits

procedure

Follow-up visits

procedure

Collection of blood by peripheral venipuncture

procedure

Collection of blood by finger prick or heel stick

procedure

Collection of blood on filterpaper

procedure

Collection of blood on filterpaper

procedure

Collection of samples for pyronaridine pharmacology analysis

procedure

Collection of samples for amodiaquine / desethylamodiaquine pharmacology analysis

procedure

Collection of samples for lumefantrine / desbutyl-lumefantrine pharmacology analysis

procedure

Collection of samples for mefloquine / carboxymefloquine pharmacology analysis

procedure

Guidelines for the collection of samples for piperaquine pharmacology analysis

procedure

Guidelines for the collection of samples for primaquine / carboxyprimaquine pharmacology analysis

procedure

Collection of samples for artemisinin pharmacology analysis

procedure

Blood PK sample processing and transport

procedure

Extraction and storage of genetic material

procedure

Urine PK sample processing and transport

procedure

Management of acute haemolysis (low dose primaquine)

procedure

Collection of ECG data in antimalarial clinical trials

procedure

Measuring temperature by ThermoScan

procedure

Digital measurement of axillary temperature

procedure

Measuring body weight

procedure

Measuring respiratory rate

procedure

Management of hyperparasitaemia

procedure

Late antimalarial treatment failure

procedure

Management of acute hemolysis (primaquine for P vivax)

procedure

Trial registration

document

PCR and sequencing for genotyping of candidate Plasmodium falciparum artemisinin resistance SNPs in the Kelch 13 gene

procedure

Sample Preservation

procedure

Leukocyte Depletion of Whole Blood Using CF11 Columns

procedure

Preparation of Culture Medium

procedure

Synchronisation of Plasmodium falciparum

procedure

Culture of Plasmodium falciparum blood stages

procedure

DNA Extraction: Preparing Rapid Diagnostic Tests

procedure

Quantification of Human and P. Falciparum DNA

procedure

Copy number estimation of the Plasmodium falciparum pfmdr1 gene

procedure

Preparation of drug plates for susceptibility assays

procedure

Estimation of Plasmodium falciparum drug susceptibility by the 3H-hypoxanthine uptake inhibition assay

procedure

Preparing malaria blood smears

procedure

Estimation of Plasmodium falciparum drug susceptibility ex vivo by HRP2 ELISA

procedure

Estimation of Plasmodium falciparum drug susceptibility by the SYBR® Green assay

procedure

DNA extraction by Chelex

procedure

DNA Extraction by QIAamp DNA Mini Kit

procedure

msp1 PCR

procedure

msp2 PCR

procedure

Manual size estimation of msp1, msp2 and glurp PCR products on gel

procedure

Agarose Gel Electrophoresis of msp1, msp2 and glurp

procedure

Microscopy for the detection, identification and quantification of malaria parasites on stained thick and thin blood films in research settings

procedure

Ring-stage Survival Assays (RSA) to Evaluate the In-Vitro and Ex-Vivo Susceptibility of Plasmodium Falciparum to Artemisinins

procedure

Guidelines for the Cryopreservation of field isolates

procedure