[Janna Gonzalez]

Hi Sarah,

In Zone 02.01.04 I would filed.
Protocol Amendment
• Protocol Amendment
• Administrative Changes
• Amendment Synopsis
• Amendments Approval Document
• Summary of Changes
• Justification for a Non-Substantial Amendment
• Protocol Amendment (CSR component)

In Zone 04.01.01

IRB or IEC Submission
• IRB or IEC Initial Submission
• IRB or IEC Continuing Review Submissions
• IRB or IEC Correspondence
o Acknowledgement of Receipts
o Questions and Answers
o Request for Additional Info
o IEC from Site
o Cover letters only responses to IRB or IEC from Site

Hope this helps!
Janna

[Janna Gonzalez]

Thank you Todd.

I have another questions.

Filing naming convention.

I’m organizing the file structure for the company. We are having a issues filing the correspondence in the correct folder for the study.

I always used The subject information.
Example

Study_IRB ICF Process_PI_31Jul2020
This document will be filed in the
IRB Relevant Communication

Thank you,
Janna

[Janna Gonzalez]

Thank you!

I have a Cover letters only responses to IRB or IEC from Site. I filed it in o4.01.01.

I have a IRB or IEC Continuing Review of Trial Cover letter only. I filed it on 04.01.02.

Is this correct?
thank you,

Janna

[Janna Gonzalez]

Hi Todd,

Thank you.

Should I named the document
Study number_Public Registration_PI_Document Date.

or

Study number_ClinicalTrial.gov_PI_Document Date?

thanks,
Janna

[Janna Gonzalez]

Hi Donna,

The DOA- Delegation of Authority document.
The date of DOA is when the PI signed the document on 4/18/2018.
The received document date 4/18/2018.

Another study team member was added to this same DOA document and signed on 5/2/2019.

This is document was not updated with the PI signature.
I rejected this document.

Can the PI just initial the document and don’t update the date?

Thanks,
Janna

Delegation of Authority_PI_most recent signature.

I have a DOA document with 01APr2011. A Study Team Member was added to this DOA with 01Apr2020.
This document won’t be approved correct.

[Janna Gonzalez]

Thank you Allison,

1) Should I File the Site Activation checklist 05.02.17 IP Site Documentation.

2) Certification of Clinical Study, not sure where to file, do you have any suggestion?

Thank you,
Janna

[Janna Gonzalez]

Thank you Everyone.

This information really helps!
Janna Gonzalez

[Janna Gonzalez]

Hi Katie,

I agreed with Joyce. Iron Mountain offers secure archiving solutions to store your physical and electronic records, with easy access when needed.

Janna

[Janna Gonzalez]

I’m organizing the Documents in my folder. I decided to run a Site Document Report. Filing Name Convention the meaningful Date and receive date. The document was upload Feb 2, 2019.
Example of Doc…

Document Name-PI-Meaningful date- Document received.

CV_Gonzalez_02Feb2018- Document Receive Date 02Feb2019.

[Author]

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