-
6th Mar 2019, 12:11 PM
#1
Electronic archiving of ISFs and E-CRFs
As a host site we only have a contract and facilities for hardcopy archiving. Sponsors often send our site's ECFs, EDC etc on a CD for archiving. It is not feasible to print these document out as they exceed 1500 per patient (as it includes full audit trails for each participant's data points).
The MHRA's position statement is (there should be) 'Appropriate archiving to ensure long term reliability, retrieval and reproducibility of electronic data (and metadata), in line with regulatory storage timelines (note this will be 25 years as standard under the new Clinical Trials Regulation 536/2014);
Is it reasonable for our archiving SOP to state that site staff print off the E-CRF pages and archive these but NOT the audit trails as this will reduce the number of pages to ~150 per patient. Is this adequate to ensure that we have archived the PI's essential documents and source data if we have assurance from the sponsor that they have long term reliability, retrieval and reproducibility of electronic data (and metadata)?
Posting Permissions
- You may not post new threads
- You may not post replies
- You may not post attachments
- You may not edit your posts
-
Forum Rules