Liaison Apprvoal Notification to Sponsor

CTP RIHSC-HSP Liaison Approval Notification for Sponsor.DOCX

Generic Clearance for the Collection of Qualitative Feedback on Food and Drug Administration Service Delivery

Liaison Apprvoal Notification to Sponsor

OMB: 0910-0697

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CTP RIHSC/HSP Liaison Approval Notification to Sponsor


IRB #: 17-052CTP

Study Title: CTP E-Blast Survey Audience Analysis Study

CTP Project Lead Name: Mario Navarro

CTP Project Lead Office: OHCE

PA Reviewer Name: Omoye Imoisili, MD

IRB(s): EXEMPT from IRB review

IAA (Y/N): NA


Package Type:

New protocol package

Amendment

Continuing renewal

Termination


Study Classification:

Exempt

Expedited

Full

Documents Submitted for review (check all that apply):

Protocol (clean and track changes)

Informed Consent (clean and track changes) – Titled “Main Study Informed Consent”

Memo


If applicable:

Stimuli approval checklist

Stimuli (clean, track changes, or memo explaining the changes)

Survey(s) (clean or track changes)

HSP-ITP checklist

Scientific review clearance form

HSP training certificates (new or updated)

Personnel CV(s) (new or updated)

Other,


Brief Description of Changes:

See PA review




APPROVAL

I, the CTP HSP liaison, have reviewed and approved the changes to study 17-054CTP as described above. There are no significant changes to human subjects protection.



CM DRESLER, MD, MPA 30 August 2019

CTP HSP liaison signature

File Typeapplication/vnd.openxmlformats-officedocument.wordprocessingml.document
AuthorLindsey, Kimberly
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File Created2021-01-15

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