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Displaying 31 - 40 of 119 results
Collection of samples for pyronaridine pharmacology analysis
Procedure
These guidelines aim to standardize the sample collection procedure during clinical studies of pyronaridine antimalarial drugs
Version: 2.0
Author: Chris Lourens
Central receipt of investigational product
Procedure
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: 2.0
Author: WWARN
Packaging and labeling investigational products/study drugs
Procedure
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
Dispensing, dosing and return of investigational product/study drug
Procedure
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
Disposal of investigational products/study drugs
Procedure
Returning investigational products/study drugs to the sponsor or arranging for their destruction at the trial site
Version: 2.0
Author: WWARN
Randomisation and blinding
Procedure
Ensuring integrity of the trial through a randomisation and blinding process
Version: 2.0
Author: WWARN
Set up and maintenance of the Investigator Site File
Procedure
A process for sites for generating important documents and a systematic filing system
Version: 2.0
Author: WWARN
Organising trial initiation meetings
Procedure
A process for when the trial site arranges the initiation meeting/visit for a trial
Version: 2.0
Author: WWARN
Trial staff training
Procedure
A process for how training of trial staff will be planned and documented
Version: 2.0
Author: WWARN
Identifying critical suppliers of trial services
Procedure
A process for sites to use when identifying and managing critical service providers/vendors
Version: 2.0
Author: WWARN