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Change of Qualified Person

FDA sponsor and CRO form for change of qualified person

Your Browser Doesn't Support Canvas. Showing the Text Content of the PDF Instead: Republic of the Philippines
Department of Health
FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG REGULATION AND RESEARCH
SPONSOR (

) / CONTRACT RESEARCH ORGANIZATION (

)

SELF-ASSESSMENT TOOLKIT FORM
CHANGE OF QUALIFIED PERSON

COMPANY NAME
COMPANY ADDRESS

:
:

NAME/POSITION OF
PREVIOUS EMPLOYEE
SERVICE ENDED
NAME OF NEW
EMPLOYEE
SERVICE BEGAN

:
:
:
:

LTO NUMBER
:
VALIDITY
:
Directions:
Fill out the form by ticking the applicable column. Provide remarks on the client’s column when necessary.
Accomplish in duplicate copies.

DOCUMENTARY REQUIREMENTS:

Yes

No

REMARKS
CLIENT

FDA

1. Application Form for LTO
 Is the application properly filled out?
 Is it duly notarized?
 Are the signatories in the application form the approving
authority and qualified person/s as required under the
following circumstances?
(a) If single proprietorship – the owner as registered in DTI
(unless there is a different authorized person)
(b) If partnership/corporation – one of the incorporators or
authorized person as indicated in the board resolution or
Secretary’s Certificate
If the signatory is not the owner or one of the incorporators, as
the case may be:

Is the board resolution or Secretary’s Certificate notarized
and clearly identify the person authorized to sign for and in
behalf of the owner or corporation?


Is the person identified in the said document the same
person who signed the Application Form and/or Contract/
Agreement?

2. Credentials of the qualified person
 Is the new qualified person identified?
 Is the Certificate of Attendance to Basic and Advance Good
Clinical Practice (GCP) Training Courses attached?
 Is the GCP Training attended within the past 3 years as
provided in the certificate?
3. Proof of Payment
 Is the payment made according to the required fee?
--- To be filled out by client: ---

1

Prepared by:
Position (Qualified Person / Owner):
Decision:
Approval
Denial
Clarification
Inspection

Signature:
Date:
--- To be filled out by FDA Officer: ---

Remarks:

Evaluated by:

Date:

--- To be filled out by CDRR: --Decision:
Approval
Clarification
Evaluated by:

Remarks:

Date:

2
 
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