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Q: If an outside source requires a copy of the SOP, what ensures proper receipt
A: The purpose of this standard operating procedure (SOP) is to provide guidance to research personnel when a system of records is established. [ Documentation of source data is necessary for the reconstruction, evaluation, and validation of clinical findings, observations, and other activities during a clinical trial. Source documentation serves to substantiate the integrity of trial data,
confirm observations that are recorded, and confirm the existence of subjects. This SOP also serves to ensure data quality by creating audit trails and enabling verification that data are present, complete, and accurate. In multi-site clinical trials it is important for documentation of source data to be standardized across all sites to ensure consistency of the trial data. Scope This SOP is based upon: 1) the Code of Federal Regulations (CFR), 2) guidances that apply to the involvement of human subjects in clinical research, and 3) standards for good clinical practice (GCP). It is applicable to all Division of AIDS (DAIDS) funded clinical trial sites conducting therapeutic, vaccine, or prevention studies on human subjects, both domestic and internationally. ]
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User: Ultimately what drives a commander's decision regarding leader assignments?

User: If an outside source requires a copy of the SOP, what ensures proper receipt

Weegy: The purpose of this standard operating procedure (SOP) is to provide guidance to research personnel when a system of records is established. [ Documentation of source data is necessary for the reconstruction, evaluation, and validation of clinical findings, observations, and other activities during a clinical trial. Source documentation serves to substantiate the integrity of trial data, confirm observations that are recorded, and confirm the existence of subjects. This SOP also serves to ensure data quality by creating audit trails and enabling verification that data are present, complete, and accurate. In multi-site clinical trials it is important for documentation of source data to be standardized across all sites to ensure consistency of the trial data. Scope This SOP is based upon: 1) the Code of Federal Regulations (CFR), 2) guidances that apply to the involvement of human subjects in clinical research, and 3) standards for good clinical practice (GCP). It is applicable to all Division of AIDS (DAIDS) funded clinical trial sites conducting therapeutic, vaccine, or prevention studies on human subjects, both domestic and internationally. ]
Serrys|Points 110|

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Asked 7/7/2013 11:21:16 AM
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