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Form 1_Protocol Review Application- Student PDF

The document is a protocol review application form for the Research Ethics Committee at Panpacific University. It requires the Principal Investigator to provide details about the study, including type, key features, participant information, and submitted documents. The form also includes sections for internal use by the committee, including review type and assessment dates.

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ungria.johara.mae
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15 views1 page

Form 1_Protocol Review Application- Student PDF

The document is a protocol review application form for the Research Ethics Committee at Panpacific University. It requires the Principal Investigator to provide details about the study, including type, key features, participant information, and submitted documents. The form also includes sections for internal use by the committee, including review type and assessment dates.

Uploaded by

ungria.johara.mae
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Panpacific University

Office of Research & Innovation


Research Ethics Committee

PROTOCOL REVIEW APPLICATION FORM

Note: The UnREC Protocol Number will be filled out by Secretariat All other items should be answered by the Prinicipal Investigator (PI)
If an item is not applicable to the project, indicate NA.

Protocol No: Submission Date:

Protocol Title:

` Signature

Telephone No. : Fax :

Email Address: Preferred Contact:

Unit/ Department, Institution Address :

Intervention Genetics Observational Study


Type of Study: Document Review Social Survey Others, Please specify,
Epidemiology Individual based

Key Features of the Study:

Yes No Involves human subject directly


Yes No Involves Informed Consent of Participants
Yes No Presence of a potential conflict of interest
Yes No Supported by a grant/sponsor
Yes No Involves research team (i.e, with co-investigators)
Yes No Part of bigger research program
Yes No Sponsor-initiated
Yes No Investifator-initiated
Yes No Global protocol
Yes No Multicenter/multi-site study
Yes No Drug-related
Yes No Vaccine-related
Yes No Medical device-related
Yes No Diagnostics
Total Number of Participants: Main Study Site Address:

If multi- sites , state other sites and


No. of Study Sites:
address(es):

Duration of implementation of
Proposed date of start of study:
the study (in months):

Target date for finalizing the report (publishable


manuscript) to PU- UnREC:

Documents submitted:

Protocol
Techinical Review Approval
Informed Consent Form
Prohect Gantt Chart
Project Team Management (if any)
Curriculum vitae of investigator(s)
Project budget ( if supported by a sponsor)
Data collection tool
Advertisement
Investigator brochure
Case Report Forms (CRF)
GCP certificates
Others:______________________________

Portion below shall be filled up by PU- UnREC:


Received by:
Date:
Secretariat, PU- UnREC

Review Type

Full Board Expedited (non- Full Board) Exempt


Assessed by:

Date:
Chairman, PU- UnREC

For Internal use only PanpacificU-ORE- Form-1-Revision- Status/ Date: 00/19September2024

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