[Janna Gonzalez]

Hi All,

Example of Documents
Confirms an IRB/IEC consists of a reasonable number of members who have the qualifications and experience to evaluate the scientific, medical and ethical aspects of a study.
IRB Membership Roster
(Each IRB Membership listing/roster required during the course of the study)
Original if Local IRB/IEC
A Copy if Central

This document is file Country & Site Level. Zone 04.01.03

Janna

[Janna Gonzalez]

Hi All,

Christy is correct.

Example of Documents
Site Feasibility Documents,
Investigative Site Feasibility Questionnaire (electronic record),
Evaluation for the medical institutions (electronic record),
Investigative Site Feasibility Questionnaire (eCRF)
Site Selection Documentation
GCP Electronic Record Regulations Applicability Assessment
Zone.05.03.01

[Janna Gonzalez]

Hi All,

Hard Copy Requirements for Clinical Trial Documents?

Thank you,
Janna

[Janna Gonzalez]

Hi Amrita,
In my experience all key research personnel Qualification documentation are filed in TMF.

Qualification documents for PI and all key research personnel
• CITI Certifications (requirement is every 2 years)
• Medical licenses for physicians and nurses
• Current CVs for all study team members
• Study-specific training: Documentation of protocol review with study team, in-service
• Research-related training documentation
• Spanning duration of study or assignment to study
• Maybe maintained in a separate “credential binder(s)” with a documentation of where to locate this.
Janna

[Janna Gonzalez]

Hi Jaclyn,

Where do I file Study level IRB Initial Approval letter?

thank you,
Janna

[Janna Gonzalez]

Hi Sarah,

Please look at the TMF RM v01. Mar2021.

Zone 02.01.04-Study/country/Site level document
Subsequent versions of the original protocol as well as supporting documentation that may include description of change(s) to or formal clarification of a protocol. Includes justification for a non-substantial amendment, such as administrative change

Protocol Amendment
Protocol Amendment Summary of Changes
Protocol Amendment Review and Approval
Protocol Amendment Synopsis
Protocol Amendment Administrative Changes
Justification For a Non-Substantial Amendment
Administrative Changes
Amendment Synopsis
Amendments Approval Document
Summary of Changes

04.0.101-This is a country/Site level document
Acknowledgement of Submission Receipt
IRB or IEC Submission
Request for Additional Information
Responses
Acknowledgement of Receipt
Questions and Answers
Request for Additional Info

Janna

[Janna Gonzalez]

Good morning,

Quick question? I have a Form Document# Type to file for my Study.

Should I use the Form#_Study#_Site#?

Ex. H00055_80-01_Gonzalez_10Mar2021

Should I use Study#_Site#_Form #

Ex. 80-01_H00055_Gonzalez_10Mar2021.

please advise.

thank you,
Janna

[Janna Gonzalez]

for non-US Clinical Trial Sites

Oops!

Correct 05.02.09.

Janna

[Janna Gonzalez]

Hi Maria,

Form FDA 1572 -known as Statement of Investigator -Defines obligations and commitments of the principal Investigator(PI).​

Is a legally binding contract between FDA and PI.​

Must be signed/dated by the Principal Investigator prior to study start and updated throughout the life of the study as needed.​
Purpose:​

To provide the sponsor with information about the PI’s qualifications and the clinical site that will enable to sponsor to establish and document the site an appropriate location at which to conduct the clinical investigation.​

To inform the PI of his/her obligations and obtain the investigator’s commitment to follow pertinent FDA regulations.​

Filing Zone 05.02.08.

Hope this helps!

Regards,
Janna

[Janna Gonzalez]

What naming file convention should we use?

Thanks,
Janna

[Janna Gonzalez]

Hi Richard,

Is one document with 2 separate items Continue review approval and Acknowledgment Annual Report.

Thank you,
Janna

[Janna Gonzalez]

This is a IRB Amendment and Approval Letter Acknowledges 3 separate items.

This documents read for ‘3_Additional Approvals’.

acknowledges 3 separate items (PV2, consent, and APR) I would like to know the suggested naming convention for documents approving of 3 separate items.

Do I need to saved three of the same documents in the three different Zones?
04.01.02,
02.01.04,
02.02.03
Thanks,
Janna
thanksn

[Janna Gonzalez]

Thank you All!

Janna

[Janna Gonzalez]

Hi Angela,

It is generated per site to assess their individual risk. Level of risk can vary from one site to the next.
Thank you,
Janna

[Janna Gonzalez]

Hi Jane,

I think you should filed in Zone 01.05.03.

Agenda, presentation materials and other documentation generated during any other internal or external zone-related meeting which documents any agreements or significant discussions. Includes meeting minutes or Q&A, attendance sheets and any pre-meeting material.

If your tracking these documents-
Pre-Organizational Meeting Agenda
Start Up Meeting Minutes, Action Items, Meeting Minutes Monitoring Plan ” -Meaningful date- Meeting Date.

Other Meeting Material-Internal
or Other Meeting Material_External (if applicable)

Hope this helps!

Janna

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