Now, if any update is done to the checklist, the history/audit trail of the story does not tell me who has done that change. It rather tells me that a generic user has done some change to the checklist. I wish to know which user has done that change (checking/u...
Validation- Locks your program for validation. Captures notes communicated during verification including checklist of verification tasks. Change Control- Assigns versions to the programs such as 1.2 to manage development and production release. This is accomplished by simply right mouse clicking on your ...
Audit and group feedback (A&F) is an instrument used to encourage healthcare professionals to improve the quality of care. Clinical practice was audited against a set of criteria and fed back to a group by a facilitator. The aim of this study was to
如果硬要区分,可以根据医院的归档方式确定,假如医院最终以电子病历归档,那打印出来的就算certified copy,如果以纸质病历归档,那打印出来的病历就算source。也可以参考EMR checklist 和 source data identification log,这两个表在试验开始前就应该确认好。3.GCP明确规定,以患者为受试者的临床试验,相关的医疗记录应当载入...