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Clinical Trial Registration and Application Form

FDA form for clinical trial registration and application

Your Browser Doesn't Support Canvas. Showing the Text Content of the PDF Instead: DEPARTMENT OF HEALTH
FOOD AND DRUG ADMINISTRATION

CLINICAL TRIAL REGISTRATION & APPLICATION FORM
1. STUDY
SPONSOR
2. ADDRESS
3. STUDY
TITLE

4. DATE OF
SUBMISSION
5. THIS
SUBMISSION
CONTAINS
THE
FOLLOWING
(Check all that
applies)

6. PHASE(S) OF
CLINICAL
TRIAL TO BE
CONDUCTED
7. NAME OF
DRUG
8. CLINICAL
TRIAL
REFERENCE
CODE /
PROTOCOL
NO.
9.STUDY
DURATION
10. PATIENT
POPULATION

Click here to
enter a date.

TELEPHONE:

INITIAL
APPLICATION

FAX:

PROTOCOL
AMENDMENT
CHANGE IN
PROTOCOL
ADDITIONAL
INVESTIGATOR
ADDITIONAL
STUDY SITE(S)
RESPONSE TO
REQUEST FOR
INFORMATION
INFORMATION
AMENDMENTS
PHASE

PHASE I

PHASE II

III

(Include Proprietary, Generic, Code):

OTHERS:

PHASE IV (POST
MARKETING
SURVEILLANCE)

11.
INVESTIGATI
ONAL PLAN/
STUDY
DESIGN
12.ERB/ERC
REVIEW TO
BE
CONDUCTED
BY
13. STUDY
SITE(s)
NAME:
14. PRINCIPAL
INVESTIGAT TELEPHONE/MOBILE:
OR
(other) IRB Approval Details:

EMAIL ADDRESS:

YES
NO
15. IS ANY PART OF
THE CLINICAL TRIAL If NO, please indicate type of organization
If YES, state the name of the CRO:
TO BE CONDUCTED
BY A CONTRACT
Attach a statement containing the name and address of
RESEARCH
CRO and the summary of responsibility
ORGANIZATION
(CRO)
16. NAME AND
CONTACT DETAILS
OF PERSON
RESPONSIBLE FOR
MONITORING
CONDUCT AND
PROGRESS OF THE
CLINICAL TRIAL
PART A: Clinical Trial Protocol and other Pertinent Documents
17. Documents
Title and aim of the trial
Submitted
Description of the trial design
Description of the subjects
Name and dosage form of product
Treatment profile
Operational aspects
Adverse events
Evaluation of results
Informed consent form, Case Report Form and Patient
Information Sheet
Resumes of Principal and other Investigators
For multi-center studies, a list of Principal Investigators
(and CVs) including trial sites

PART B: Pharmaceutical Data
GMP statement from manufacturing/Certificate from
Regulatory Body
Certificate of Analysis
Stability Data (storage conditions)
Manufacturing Data & Formulation
Product labeling (coded & labeled: blinding)
PART C: Investigator’s Brochure (Efficacy and Safety Data)
Safety Data:
Non-Clinical Studies
Pharmacology; PK/PD studies
Toxicology Studies
Marketing Experience, Periodic Safety Update Reports
(PSUR), product status if marketed abroad
Risks and ADR anticipated
Efficacy Data:
PK/PD Data in human subjects
In-house preliminary data
Summaries of clinical trial studies conducted (Phase I, II, III)

Published clinical data
18. Submitted by
(Below to be filled by CTU officer)
CLINICAL
TRIAL
REFERENCE
(CTR)
NUMBER:
DATE OF
ISSUE:
RECEIVED BY:
 
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