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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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QA07
Trial risk assessment (by the site)
A process for assessing the risk of an institutional team conducting a trial
Version: 2.0 Author: WWARN
QA06
Set up and maintenance of the Sponsor File
For when an investigator/institution takes responsibility for setting up and maintaining the sponsor file
Version: 2.0 Author: WWARN
QA05
Pre-trial site assessment
For when an investigator/institution may take responsibility for selecting sites for a clinical trial
Version: 2.0 Author: WWARN
QA04
Site handling of monitoring visits
A process for sites to use to help staff involved with attending or arranging monitoring visits
Version: 2.0 Author: WWARN
QA03
Non compliance
A process for sites for identifying, documenting and reporting non-compliance during a clinical trial
Version: 2.0 Author: WWARN
QA02
Standard operating procedure management
A process for authorship, review, authorisation, issue and control of standard operating procedures by a site
Version: 2.0 Author: WWARN
IP05
Randomisation and blinding
Ensuring integrity of the trial through a randomisation and blinding process
Version: 2.0 Author: WWARN
IP04
Disposal of investigational products/study drugs
Returning investigational products/study drugs to the sponsor or arranging for their destruction at the trial site
Version: 2.0 Author: WWARN
IP03
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: 2.0 Author: WWARN
IP02
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: 2.0 Author: WWARN

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