unable to find the original document of following reference from FDA...
?The Facts About Source Documents" Stan W. Woollen, Deputy Director, Division of Scientific Investigations in June 199
http://www.mtnstopshiv.org/sites/default/files/attachments/SourceDocSOPv2.pdf
thought of sharing the same and getting lucky to trace the original document,...
?The Facts About Source Documents" Stan W. Woollen, Deputy Director, Division of Scientific Investigations in June 199
http://www.fda.gov/downloads/training/guidancewebinars/ucm383657.pdfEnsure ALCOA* to achieve data quality.
1. Attributable: is it obvious who wrote it?
- Who entered the data?
- Audit trail!
2. Legible: can it be read?
- Electronic data & metadata in human-readable form
- Modifications should not obscure prior entries
- Audit trail!
3. Contemporaneous: is the information current and in the correct time frame?
- The time of data entry into the ...form ...should be close proximity to the time of ...activity.
- Audit trail!
4. Original: is it a copy; has it been altered?
- Earliest record
- Changes and / or corrections should not obscure prior entries.
- Audit trail!
5. Accurate: are conflicting data recorded elsewhere?
- valid representation of the source data.
- Corrections should be documented.
- Quality control measures / processes.
- Audit trail!
http://www.mtnstopshiv.org/sites/default/files/attachments/SourceDocSOPv2.pdf
thought of sharing the same and getting lucky to trace the original document,...