Forum Replies Created
March 30, 2021 at 9:11 pm in reply to: What Type of Documents Need to be Certified When eFiling? #4066
The regulations state that if you have paper originated documents that you destroy, the copies should be certified. If you have the files electronically, you could use these and not scan and certify, but I would personally assess the effort of just scanning all the documents from paper (certified process) versus scanning some and finding some electronic and filing the electronic ones in between the scanned paper documents!
In addition, you need to be sure that the electronic documents have not been changed over the years.
Hi Mariz. If you look under resources you will find an email communication guide and webinar recording – these will help!
KarenDecember 14, 2020 at 10:05 pm in reply to: Working with a CRO who won’t file ‘outside’ documents #3900
There are a number of slides that the MHRA have presented that support that section 8 is not sufficient. They may help – email me and I can send them. firstname.lastname@example.org
KarenDecember 4, 2020 at 3:07 pm in reply to: Where to file Site Activation Letter/Center Activation Checklist? #3879
Can I advise that you look at TMF RM 3.2 with the new set of sub-artifacts? This will assiste with where to file documents.
Assuming there is still a Sponsor funding the project, I would put the CVs in Zone 9. If the CRO is also the Sponsor, then Zone 1.