Hi,
Vishal's comment on CRF and source notes appears at the end of Wednesday'S log on 'What is ICH'.
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A fun and informative blog on what is and what isn't happening in the clinical research space in India. With stuff you can use!! And views you can share.
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- Anupama
- An independent Clinical research professional ,based in India,promoting ethics,quality and innovation in Clinical research
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Greetings madam,
Recently at a site one of the Investigators had a very different method of storing source data.
He wrote the patient visit details onto the prescription papers, then he scanned the prescription papers and stored on the system. Then he shred all the source notes that is prescription papers as in his own words''it became very bulky'!!!
When asked he said that his system is validated and regular back ups of the data is taken.Moreover he also filed a print out of the scanned document in the file.(!!!)
My question to all is that whether signed scanned copy alone of a source document is enough without the original document or not.Please comment.
if the procedure is validated and has an audit trail,and regular back up of data is there AND the investigator has this in a written auditable SOP ,then it might be considered as an option. GCP does say a certified copy of an original can also be source data.
if the procedure is validated and has an audit trail,and regular back up of data is there AND the investigator has this in a written auditable SOP ,then it might be considered as an option. GCP does say a certified copy of an original can also be source data.
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