Provides guidance for documentation of the source of data collected during the conduct of this clinical trial. Source documentation serves to substantiate the integrity of study data, confirms observations that are recorded, and confirms the existence of study participants. The existence of verifiable source documents ensures data quality.
Describes how the informed consent process will be administered at this research site, who will be responsible for administering informed consent, and under what circumstances informed consent will be obtained.
Defines procedures for transferring Study Drug from the Study Pharmacy to the participant’s ward staff and returning Study Drug to the Study Pharmacy from the ward.
Describes how local study specimens are collected, transported, processed, stored, shipped and how the chain of custody related to testing for primary endpoints is maintained. Also, to define for all clinical and laboratory study personnel the proper and safe way to handle infectious specimens in compliance with federal, institutional and protocol regulations and guidelines.
