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Change of Delegated Sponsor Activities

FDA sponsor and CRO form for change of delegated sponsor activities

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Department of Health
FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG REGULATION AND RESEARCH
CONTRACT RESEARCH ORGANIZATION
SELF-ASSESSMENT TOOLKIT FORM
DELETION OF ACTIVITY

COMPANY NAME
COMPANY ADDRESS

:
:

ACTIVITY TO BE
DELETED

:

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.
REMARKS

DOCUMENTARY REQUIREMENTS:

Yes

No

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 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. Updated Delegation of Authority (where applicable)
 Is/Are the delegation/s of authority of existing clinical
research/es updated and attached?
 Are the names and other important details of licensed
establishments indicated?
 Are the roles and responsibilities between the Sponsor and
CRO clearly defined and in accordance with the updated
activity/ies?
3. Affidavit to Prove Deletion of Activity/ies
 Is the attached affidavit valid, duly notarized/authenticated?
4. Proof of Payment
 Is the payment made according to the required fee?

1

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

--- To be filled out by client: --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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