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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.

Data management tables for standard efficacy analysis
These are template database tables for use in a typical malaria efficacy trial analysis
Version: v1.0 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
PHA_DM02
Serious adverse event reconciliation
For when there is a need to reconcile safety data that are stored in two different databases during a clinical trial
Version: v1.0 Author: WWARN
PHA_DM01
Data management protocol generic
Instruction to those data management team members delegated responsibility for producing and working on a data management protocol
Version: v1.0 Author: WWARN
CLI20; PHA11
Malaria Case Record Form (CRF)
Malaria Clinical Trial Case Record Form
Version: v2.0 Author: WWARN
PHA_QMP
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: v1.0 Author: WWARN
PHA_QA07
On-site monitoring
For when an investigator/institution takes responsibility for on-site monitoring of a clinical trial
Version: v1.0 Author: WWARN
PHA_QA06
Trial risk assessment (by the site)
This procedure describes the process for assessing the risk of an institutional team conducting a trial
Version: v1.0 Author: WWARN
PHA_QA05
Set up and maintenance of the Sponsor File
For when an investigator/institution takes responsibility for setting up and maintaining the sponsor file
Version: v1.0 Author: WWARN
PHA_QA04
Pre-trial site assessment
For when an investigator/institution may take responsibility for selecting sites for a clinical trial
Version: v1.0 Author: WWARN

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89 results

Serious Adverse Event Management

Identifying, assessing and reporting serious adverse events during antimalarial drug efficacy trials
Version: v1.0 Author: WWARN CLI04 Participants: Clinical Scientific Group

Blood collection: peripheral venipuncture

Collecting peripheral blood samples
Version: v1.0 Author: WWARN CL108 Participants: Clinical Scientific Group

Weight Measurement

Measuring and recording patient weight in antimalarial drug efficacy trials
Version: v1.0 Author: WWARN CLI02 Participants: Clinical Scientific Group

Temperature Measurement: Digital Thermometer

Measuring and recording patient axillary body temperature in clinical trials
Version: v1.0 Author: WWARN CLI17 Participants: Clinical Scientific Group

Sample Preservation

Collecting and preserving DNA, RNA and parasite isolates from infected blood samples
Version: v1.5 Author: WWARN MOL01 Participants: Molecular Scientific Group

Collection of blood by finger prick and heel stick

Obtaining fingerprick and heel stick blood samples for preparing thick/thin blood smears and filter paper samples
Version: v1.2 Author: WWARN CLI07 Participants: Clinical Scientific Group

Temperature Measurement: Braun Thermoscan Thermometer

Measuring and recording patient tympanic membrane body temperature in clinical trials
Version: v1.2 Author: WWARN CLI16 Participants: Clinical Scientific Group

Respiratory Rate Measurement

Measuring and recording patient respiratory rate in antimalarial drug efficacy trials
Version: v1.0 Author: WWARN CLI01 Participants: Clinical Scientific Group

Leukocyte Depletion of Whole Blood Using CF11 Columns

Version: v1.3 Author: WWARN MOL02 Participants: Molecular Scientific Group

Collection of blood on filterpaper

Preparing and preserving dried blood spot samples for genetic analysis
Version: v1.2 Author: WWARN MOL03, CLI06 Participants: Molecular Scientific Group, Clinical Scientific Group

Database Construction and Security

Construction, security and backup of a clinical database
Version: v1.0 Author: WWARN PHA01 Participants: Pharmacology Scientific Group

Data Receipt, Entry and Validation

Receiving, tracking and validating data within a clinical trial
Version: v1.0 Author: WWARN PHA02 Participants: Pharmacology Scientific Group

Preparation of Culture Medium

Preparing complete medium for Plasmodium falciparum cultures
Version: v1.1 Author: WWARN INV02 Participants: In Vitro Scientific Group

Synchronisation of Plasmodium falciparum

Synchronising culture adapted Plasmodium falciparum isolates in ring stage
Version: v1.1 Author: WWARN INV04 Participants: In Vitro Scientific Group

Culture of Plasmodium falciparum blood stages

Methods for short- and long term culture of Plasmodium falciparum laboratory strains and fresh isolates
Version: v1.0 Author: WWARN INV01 Participants: In Vitro Scientific Group

DNA Extraction: Preparing Rapid Diagnostic Tests

Storing and processing malaria Rapid Diagnostic Tests (RDTs) for DNA extraction
Version: v1.1 Author: WWARN MOL06 Participants: Molecular Scientific Group

Quantification of Human and P. Falciparum DNA

Estimating Plasmodium falciparum and human DNA concentration in infected blood samples by fluorometer and real-time PCR
Version: v1.0 Author: WWARN MOL04 Participants: Molecular Scientific Group

Copy number estimation of the Plasmodium falciparum pfmdr1 gene

Estimating pfmdr1 gene copy number by real-time PCR
Version: v1.1 Author: WWARN MOL05 Participants: Molecular Scientific Group

Preparation of drug plates for susceptibility assays

Preparation of drug dilutions in dry or fresh plates for drug susceptibility assays
Version: v1.2 Author: WWARN INV03 Participants: In Vitro Scientific Group

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

Drug susceptibility assay measuring radioactive hypoxanthine uptake in laboratory strains and fresh isolates.
Version: v1.0 Author: WWARN INV07 Participants: In Vitro Scientific Group

Blood Smear Preparation

Preparing thick and thin blood smears with Giemsa staining
Version: v1.0 Author: WWARN CLI10 Participants: Clinical Scientific Group

Adverse Event Management

Identifying, assessing and reporting adverse events during antimalarial drug efficacy trials
Version: v1.1 Author: WWARN CLI05 Participants: Clinical Scientific Group

Estimation of Plasmodium falciparum drug susceptibility ex vivo by HRP2 ELISA

Drug susceptibility assay measuring histidine-rich protein production by ELISA in fresh isolates
Version: v1.0 Author: WWARN INV09 Participants: In Vitro Scientific Group

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

Drug susceptibility assay measuring SYBR®Green I fluorescence in laboratory strains and field isolates
Version: 1.0 Author: WWARN INV08 Participants: In Vitro Scientific Group

Collection of blood on filterpaper

Preparing dried blood spots by finger prick
Version: 1.0 Author: Mekong Molecular Surveillance Network EXT01 Participants: Molecular Scientific Group, Clinical Scientific Group

DNA extraction by Chelex

Extracting Plasmodium spp. DNA from dried blood spots by Chelex 100
Version: 1.0 Author: Mekong Molecular Surveillance Network EXT02 Participants: Molecular Scientific Group

DNA Extraction by QIAamp DNA Mini Kit

Extracting Plasmodium spp. DNA from dried blood spots by QIAamp DNA Mini Kit
Version: 1.0 Author: Mekong Molecular Surveillance Network EXT03 Participants: Molecular Scientific Group

msp1 PCR

PCR amplification of the polymorphic marker msp1 to distinguish recrudescences from reinfections
Version: 1.0 Author: Mekong Molecular Surveillance Network EXT05 Participants:

msp2 PCR

PCR amplification of the polymorphic marker msp2 to distinguish recrudescences from reinfections
Version: 1.0 Author: Mekong Molecular Surveillance Network EXT09 Participants: Molecular Scientific Group, Clinical Scientific Group

glurp PCR

PCR amplification of the polymorphic marker glurp to distinguish recrudescences from reinfections
Version: 1.0 Author: Mekong Molecular Surveillance Network EXT06 Participants: Molecular Scientific Group, Clinical Scientific Group

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

Manually determining the size of Plasmodium falciparum polymorphic markers to distinguish recrudesent from reinfecting infections in clinical trials
Version: 1.0 Author: Mekong Molecular Surveillance Network EXT08 Participants: Clinical Scientific Group, Molecular Scientific Group

Agarose Gel Electrophoresis of msp1, msp2 and glurp

Separating and visualising amplified PCR products of msp1, msp2 and glurp
Version: 1.0 Author: Mekong Molecular Surveillance Network EXT07 Participants:

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

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 INV10 Participants: In Vitro Scientific Group

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

Genotyping of SNPs in the Kelch 13 gene (PF3D7_1343700), associated with artemisinin resistance
Version: 1.0 Author: D. Menard & F. Ariey Institut Pasteur MOL08 Participants: Molecular Scientific Group

AE_SAE Improvement

Version: 1.0 Author: WWARN CLI18 Participants: Clinical Scientific Group

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

This manual was developed to guide a move towards common standards for undertaking and reporting research microscopy for malaria parasite detection, identification and quantification.
Version: 1.0 Author: Research Malaria Microscopy Standards Working Group EXT10 Participants:

Guidelines for the collection of samples for pyronaridine pharmacology analysis

These guidelines aim to standardize the sample collection procedure during clinical studies of pyronaridine antimalarial drugs
Version: 1.0 Author: Chris Lourens PHA04 Participants: Pharmacology Scientific Group

Guidelines for the collection of samples for amodiaquine / desethylamodiaquine pharmacology analysis

These guidelines aim to standardize the sample collection procedure during clinical studies of pyronaridine antimalarial drugs
Version: 1.0 Author: Chris Lourens PHA05 Participants: Pharmacology Scientific Group

Guidelines for the collection of samples for lumefantrine / desbutyl-lumefantrine pharmacology analysis

These guidelines aim to standardize the sample collection procedure during clinical studies of lumefantrine / desbutyl-lumefantrine antimalarial drugs
Version: 1.0 Author: Chris Lourens PHA06 Participants: Pharmacology Scientific Group

Guidelines for the collection of samples for mefloquine / carboxymefloquine pharmacology analysis

These guidelines aim to standardize the sample collection procedure during clinical studies of mefloquine / carboxymefloquine antimalarial drugs
Version: 1.0 Author: Chris Lourens PHA07 Participants: Pharmacology Scientific Group

Guidelines for the collection of samples for piperaquine pharmacology analysis

These guidelines aim to standardize the sample collection procedure during clinical studies of piperaquine antimalarial drugs
Version: 1.0 Author: Chris Lourens PHA08 Participants: Pharmacology Scientific Group

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

These guidelines aim to standardize the sample collection procedure during clinical studies of primaquine / carboxyprimaquine antimalarial drugs
Version: 1.0 Author: Chris Lourens PHA09 Participants: Pharmacology Scientific Group

Guidelines for the collection of samples for artemisinin pharmacology analysis

These guidelines aim to standardize the sample collection procedure during clinical studies of artemisinin antimalarial drugs
Version: 1.0 Author: Chris Lourens PHA10 Participants: Pharmacology Scientific Group

Guidelines for the Cryopreservation of field isolates

The purpose of this document is to standardize the methodology for cryopreservation of malaria parasites using glycerolyte
Version: 1.0 Author: Dr. Kesinee Chotivanich EXT11 Participants:

Obare Method Calculator

A tool to calculate the mean parasite density and assessing whether two blood samples are concordant
Version: v1.0 Author: Obare CLI19 Participants:

Malaria Case Record Form (CRF)

Malaria Clinical Trial Case Record Form
Version: v2.0 Author: WWARN CLI20; PHA11 Participants: Pharmacology Scientific Group

Piperaquine Survival Assays (PSA) to evaluate the in-vitro and ex-vivo susceptibility of Plasmodium falciparum to piperaquine

This procedure describes two assays to evaluate the susceptibility of Plasmodium falciparum to piperaquine.
Version: V1.0 Author: Benoit Witkowski & Didier Ménard, Institut Pasteur du Cambodge INV11 Participants:

Archiving of clinical trial Essential Documents

The process for archiving Essential Documents generated during a clinical trial
Version: v1.0 Author: WWARN PHA_AD01 Participants:

General preparation for clinical trial conduct

The process for ensuring that stock, equipment, documentation, staff and venue are adequately prepared for a new clinical trial
Version: v1.0 Author: WWARN PHA_AD02 Participants:

Set up and maintenance of the Investigator Site File

The process for generating important documents and a systematic filing system to follow (usually called an Investigator Site File)
Version: v1.0 Author: WWARN PHA_AD03 Participants:

Organising trial initiation meetings

The process for when the trial site arranges the initiation meeting/visit for a trial
Version: v1.0 Author: WWARN PHA_AD04 Participants:

Preparing for scheduled trial admission periods

The process for ensuring that issues such as stock, equipment, staff, participants and venue are adequately prepared for scheduled ward admission periods
Version: v1.0 Author: WWARN PHA_AD05 Participants:

Pre- and post-admission team meetings

The rationale and conduct of pre- and/or post-admission team meetings which help ensure the trial team works together correctly and efficiently
Version: v1.0 Author: WWARN PHA_AD06 Participants:

Data recording by clinical trial staff

A process for how clinical trial staff should record source and Case Record Form (CRF) data for trials
Version: v1.0 Author: WWARN PHA_AD07 Participants:

Trial staff training

A process for how training of trial staff will be planned and documented
Version: v1.0 Author: WWARN PHA_AD08 Participants:

Identifying critical suppliers of trial services

A process for how critical service providers (suppliers/vendors) are identified, selected and managed to ensure they are suitably qualified, skilled, experienced or otherwise able to provide the quality of service required for a clinical trial
Version: v1.0 Author: WWARN PHA_AD09 Participants:

Clinical trial project management

Some basic project management functions that may be used by team members responsible for project management
Version: v1.0 Author: WWARN PHA_AD10 Participants:

Screening visits

The process for preparing for and conducting participant screening during a clinical trial
Version: v1.0 Author: WWARN PHA_CL01 Participants:

Informed consent

A process for how informed consent may be obtained from competent adults, and may be adapted for other participants
Version: v1.0 Author: WWARN PHA_CL02 Participants:

Follow-up visits

The process for preparing for and conducting participant follow-up visits during a clinical trial
Version: v1.0 Author: WWARN PHA_CL03 Participants:

Clinical conduct of scheduled admission periods

The process for ensuring that scheduled ward admission periods are conducted appropriately
Version: v1.0 Author: WWARN PHA_CL04 Participants:

Blood PK sample processing and transport

The process for taking pharmacokinetic samples from the phlebotomist to processing in an interim processing (e.g. ward) laboratory and onto an analytical laboratory in clinical trials
Version: v1.0 Author: WWARN PHA_CL05 Participants:

Extraction and storage of genetic material

A general process for collecting and processing of genetic material from blood samples in clinical trials
Version: v1.0 Author: WWARN PHA_CL06 Participants:

Urine PK sample processing and transport

The process for collecting and sampling for urine pharmacokinetic measurements in clinical trials
Version: v1.0 Author: WWARN PHA_CL07 Participants:

Management of acute haemolysis for field sites

A simplified process for field site staff to identify and manage any cases of suspected acute haemolysis in a clinical trial (such as trials involving low-dose primaquine)
Version: v1.0 Author: WWARN PHA_CL08 Participants:

Management of hyperparasitaemia

A process for case management of patients with uncomplicated hyperparasitaemia in field studies, particularly for sites without resident microscopy facilities or a medical doctor
Version: v1.0 Author: WWARN PHA_CL09 Participants:

Late antimalarial treatment failure

A process for case management of patients with uncomplicated malaria who fail first line treatment in antimalarial field trials
Version: v1.0 Author: WWARN PHA_CL10 Participants:

General evacuation of the clinical trial facility

A process for the evacuation of a clinical trial facility in the event of a non-medical emergency
Version: v1.0 Author: WWARN PHA_EM01 Participants:

Evacuating a patient in the event of a medical emergency

A process for safely evacuating a patient due to a medical emergency from the clinical trial facility
Version: v1.0 Author: WWARN PHA_EM02 Participants:

Post-exposure prophylaxis in the clinical trial facility

A process for dealing with inadvertent exposure to potentially infectious fluids during a clinical trial
Version: v1.0 Author: WWARN PHA_EM03 Participants:

Emergency scenario training for clinical trial facilities

Version: v1.0 Author: WWARN PHA_EM04 Participants:

Medical emergencies at field trial sites

A process for managing medical emergencies in trial participants at field sites
Version: v1.0 Author: WWARN PHA_EM05 Participants:

Central receipt of investigational product

For when a PI/institution may need to receive investigational product (study drug) for several sites at a central location before they are allocated to individual sites
Version: v1.0 Author: WWARN PHA_IP01 Participants:

Packaging and labeling investigational products/study drugs

Generating labels for, and packaging, investigational product/study drug (IP) by the trial site in accordance with a typical Good Pharmacy Practice guideline
Version: v1.0 Author: WWARN PHA_IP02 Participants:

Dispensing, dosing and return of investigational product/study drug

Dispensing and dosing of investigational products/study drugs and their return to a pharmacy/drug store for a clinical trial.
Version: v1.0 Author: WWARN PHA_IP03 Participants:

Disposal of investigational products/study drugs

Returning investigational products/study drugs to the sponsor or arranging for their destruction at the trial site
Version: v1.0 Author: WWARN PHA_IP04 Participants:

Randomisation and blinding

Ensuring integrity of the trial through a randomisation and blinding process
Version: v1.0 Author: WWARN PHA_IP05 Participants:

Standard operating procedure management

The process for authorship, review, authorisation, issue and control of standard operating procedures by a clinical trial site
Version: v1.0 Author: WWARN PHA_QA01 Participants:

Non compliance

The process for identifying, documenting and reporting non-compliance during a clinical trial
Version: v1.0 Author: WWARN PHA_QA02 Participants:

Site handling of monitoring visits

How site staff involved with attending or arranging monitoring visits should prepare for or behave during such visits
Version: v1.0 Author: WWARN PHA_QA03 Participants:

Pre-trial site assessment

For when an investigator/institution may take responsibility for selecting sites for a clinical trial
Version: v1.0 Author: WWARN PHA_QA04 Participants:

Set up and maintenance of the Sponsor File

For when an investigator/institution takes responsibility for setting up and maintaining the sponsor file
Version: v1.0 Author: WWARN PHA_QA05 Participants:

Trial risk assessment (by the site)

This procedure describes the process for assessing the risk of an institutional team conducting a trial
Version: v1.0 Author: WWARN PHA_QA06 Participants:

On-site monitoring

For when an investigator/institution takes responsibility for on-site monitoring of a clinical trial
Version: v1.0 Author: WWARN PHA_QA07 Participants:

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: v1.0 Author: WWARN PHA_QMP Participants:

Data management protocol generic

Instruction to those data management team members delegated responsibility for producing and working on a data management protocol
Version: v1.0 Author: WWARN PHA_DM01 Participants:

Serious adverse event reconciliation

For when there is a need to reconcile safety data that are stored in two different databases during a clinical trial
Version: v1.0 Author: WWARN PHA_DM02 Participants:

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 PHA_DM03 Participants:

Data management tables for standard efficacy analysis

These are template database tables for use in a typical malaria efficacy trial analysis
Version: v1.0 Author: WWARN Participants: