Well, it depends on the capabilities of your cloud system. There are several open access cloud based systems that don't provide the level of security and flexibility of a document management system designed for clinical trials. A big one Part 11 software validation Also, as a sponsor, you are required to submit interim, annual reports among several other things, that need signatures, which if electronic need Part 11 compliance. I'm just saying if you are confident that your cloud based system can comply with the requirements and prove it, you're good to go.
A few other SOPs I can think of: Site selection, SIV, Training, Vendor management, Subject recruitment materials, any administrative & financial SOPs, Electronic Data Capture (?), management of studies, record keeping.
21 CFR 312 and ICH-GCP are some of the best resources.
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Vidyalakshmi Jayaraman
Marlborough MA
United States
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Original Message:
Sent: 18-Jan-2018 14:10
From: Anonymous Member
Subject: Re: SOPs
This message was posted by a user wishing to remain anonymous
Thank you, Vidyalakshmi.
We are the sponsors of the trial and the manufacturing is outsourced to a CRO. However, even as sponsors we need at least a few SOPs. Some of those I can think of include SOPs for product recall, Safety reporting.
I do not think using a secured access system for storing patient data or IP should be a problem. All proprietary documents such as the IB, protocol, SOPs, etc. are part of the IP and of course, the cloud system is being used to house all these documents. Therefore, I do not agree with your suggestion that you should be any more careful using it for patient data. Thank you.
Original Message:
Sent: 18-Jan-2018 13:36
From: Vidyalakshmi Jayaraman
Subject: Re: SOPs
Hello-
Are you a manufacturer of a product that's entering clinical investigation phase or a clinical research site/organization? Your regulatory requirements and SOPs would vary accordingly. Same for part 11. 21 CFR 11 is quite prescriptive & easy to follow - if you have electronic records which are subject to audits, they must have secure access on a validated platform, allowing only authenticated users. There are also requirements on electronic signatures. If your cloud service enables this, an NTF would suffice. But I would be very careful about using it for IP and patient/clinical data.
Sorry couldn't help with q 2 and 4.
Best
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Vidyalakshmi Jayaraman
Marlborough MA
United States
Original Message:
Sent: 17-Jan-2018 17:49
From: Anonymous Member
Subject: Re: SOPs
This message was posted by a user wishing to remain anonymous
Hello,
We are a start-up organization moving into clinical investigation:
1. What are the minimum Standard Operating Procedures (SOPs) we must have in place to ensure that we are inspection ready and in compliance with FDA regulations? A list of SOPs would be appreciated.
2. What is the difference between publishing an eCTD sequence versus making a submission via the ESG gateway? It is my understanding that the ESG gateway is the method through which all electronic information is transmitted, including the eCTD modules. So then what is the difference between submitting regular eCTD modules through the ESG versus spending money and hiring publishers to do an 'eCTD' submission?
3. If using a cloud system for document storage, will a note-to-file explaining compliance with 21 CFR 11 suffice?
4. In several organizations, I have noticed that they have filed for a waiver from environmental assessment citing "Action on IND" during initial IND submission. What does this mean ("action on IND")? And is an organization supposed to conduct an environmental assessment in the future, if the waiver is granted during the initial IND application?
Thank you!!