Form 3 Attach 4 Supplemental Investigator data form

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OMB No. 0925-0613
Expiration Date: 03/31/2016

Collection of this information is authorized under 21 CFR 312.53. Collection of this information serves two purposes. The first is to
identify qualified investigators and associates to participate in clinical investigations at the National Cancer Institute. This information
may be disclosed to researchers for research purposes, sponsors of clinical trials, the applicable Institutional Review Board, National
Cancer Institute, Food and Drug Administration’s Center for Drug Evaluation and Research and Center for Biologics Evaluation and
Research, and the Department of Health and Human Services. The second purpose is to ensure that investigational agents are under the
control and accounted for by a competent authority. Submission of this information is voluntary, however, in order for us to qualify you
to conduct a study in accordance with the relevant, current protocol(s), you must complete all fields.
Public reporting burden for this collection of information is estimated to average 10 minutes per response, including the time for reviewing instructions, searching existing data sources, gathering
and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for
reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0613). Do not return the completed form to this address.

SUPPLEMENTAL INVESTIGATOR DATA FORM
Date (MM/DD/YYYY):____ / ____ / ______
Sections 1 – 12: REQUIRED INFORMATION (Collected for all investigators participating in CTEP-sponsored clinical trials.)
1. Investigator Name (Last, First, Middle, Suffix):
4. Date of Birth (MM/YYYY):
__ __ / __ __ __ __

2. Degree(s):
5. Provider No. (NPI):

7. Primary Specialty Practice(s): Check all that apply.

Board
Eligible:

6. Are you currently licensed to practice medicine?
Board
Certified:

YES
Board
Eligible:

Anatomic and/or Clinical Pathology

Obstetrics and Gynecology

Clinical Genetics

Orthopedic Surgery

Colon and Rectal Surgery

Otolaryngology

Dermatology

Pediatric Hematology-Oncology

Diagnostic Radiology

Pediatrics

Family Practice

Psychiatry

Gastroenterology

Public Health and General Preventative Medicine

Gynecological Oncology

Radiation Oncology

Hematology

Surgery

Internal Medicine

Surgical Oncology

Medical Oncology

Thoracic Surgery

Neurological Surgery

Urology

Neurology

Other __________________________

8. Have you received training in:

3. CTEP Investigator ID:
NO

Board
Certified:

Completion of this training is mandatory for all CTEP-registered investigators.

“Protection of Human Research Participants”?

YES

DATE COMPLETED (MM/YYYY): __ __ / __ __ __ __

In sections 9 – 12, use this side to either enter new information or view current
information.

In sections 9 – 12, use this side to make changes to current information only.

9. Office Address: The office address and contact information will be used for receipt of all official correspondence.
Institution:

_____________________________________________________

Institution:

___________________________________________________

Internal Office:

_____________________________________________________

Internal Office:

___________________________________________________

Street Address:

_____________________________________________________

Street Address:

___________________________________________________

Street Address:

_____________________________________________________

Street Address:

___________________________________________________

City:

_____________________________________________________

City:

___________________________________________________

State/Province:

_____________________________________________________

State/Province:

___________________________________________________

Zip/Postal Code:

_____________________________________________________

Zip/Postal Code:

___________________________________________________

Country:

_____________________________________________________

Country:

___________________________________________________

Office Phone No.:

_____________________________________________________

Office Phone No.:

___________________________________________________

Office FAX No.:

_____________________________________________________

Office FAX No.:

___________________________________________________

Office E-mail:

________________________________________________

Office E-mail:

_______________________________________________

10. Research Contact: Provide a phone number and email address, suitable for display on a publicly accessible website (e.g., www.cancer.gov), which can be used by a patient to
contact the investigator’s research staff to inquire about clinical trials approved by their IRB and open for enrollment at their institution.
Research Contact Phone No. _____________________________________

Research Contact Phone No. _____________________________________

Research Contact E-mail address ___________________________________

Research Contact E-mail address ___________________________________

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Supplemental Investigator Data Form

11. Primary Shipping Address: The primary shipping address will be used for receipt of all CTEP-supplied investigational agents.
Institution:

_____________________________________________________

Institution:

___________________________________________________

Internal Office:

_____________________________________________________

Internal Office:

___________________________________________________

Street Address:

_____________________________________________________

Street Address:

___________________________________________________

Street Address:

_____________________________________________________

Street Address:

___________________________________________________

City:

_____________________________________________________

City:

___________________________________________________

State/Province:

_____________________________________________________

State/Province:

___________________________________________________

Zip/Postal Code:

_____________________________________________________

Zip/Postal Code:

___________________________________________________

Country:

_____________________________________________________

Country:

___________________________________________________

Shipping Designee: Provide name of shipping designee (preferably a pharmacist) approved to order and receive CTEP-supplied investigational agents.
Shipping Designee Name:

__________________________________________

Shipping Designee Name:

________________________________________

Shipping Designee Phone No.:

__________________________________________

Shipping Designee Phone No.:

________________________________________

Shipping Designee FAX No.:

__________________________________________

Shipping Designee FAX No.:

________________________________________

Shipping Designee E-mail:

______________________________________

Shipping Designee E-mail:

_______________________________________________________________________
CTEP USE ONLY:

PSD

SD

____________________________________

_____________________________________________________________________

IA

12. Ordering Designee(s): Provide name(s) of ordering designee(s) approved to order CTEP-supplied investigational agents. Note that a “Clinical Drug Request (CDR) Form” for a
CTEP-supplied agent must be signed by either the investigator, the authorized shipping designee (from item #11), or an ordering designee (from item #12). An ordering
designee must use the primary shipping address (from item #11).
A.

B.

C.

Ordering Designee Name:

____________________________________

Ordering Designee Phone No.:

Ordering Designee Name:

___________________________________

____________________________________

Ordering Designee Phone No.:

__________________________________

Ordering Designee Fax No.:

____________________________________

Ordering Designee Fax No.:

__________________________________

Ordering Designee E-mail:

____________________________________

Ordering Designee E-mail:

__________________________________

Ordering Designee Name:

____________________________________

Ordering Designee Name:

___________________________________

Ordering Designee Phone No.:

____________________________________

Ordering Designee Phone No.:

__________________________________

Ordering Designee Fax No.:

____________________________________

Ordering Designee Fax No.:

__________________________________

Ordering Designee E-mail:

____________________________________

Ordering Designee E-mail:

__________________________________

Ordering Designee Name:

____________________________________

Ordering Designee Name:

___________________________________

Ordering Designee Phone No.:

____________________________________

Ordering Designee Phone No.:

__________________________________

Ordering Designee Fax No.:

____________________________________

Ordering Designee Fax No.:

__________________________________

Ordering Designee E-mail:

____________________________________

Ordering Designee E-mail:

__________________________________

Please be sure you have also included:

1.
2.
3.

A.

B.

C.

Completed FDA Form 1572 with original signature.
Current Curriculum Vitae (CV).
Completed FinaCTEPal Disclosure Form with original signature.

I certify that the information on this “Supplemental Investigator Data Form” is true and correct to the best of my knowledge.
Investigator:

Date:
(Signature)

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Supplemental Investigator Data Form

Section
1.
2.
3.

4.
5.
6.
7.
8.

9.

10.
11.

12.

INSTRUCTIONS FOR COMPLETING THE “SUPPLEMENTAL INVESTIGATOR DATA FORM”
Investigator Name: Provide legal last name, first name, middle initial or name, and suffix (if applicable).
Degree(s): Provide degree(s) (e.g., M.D., D.O., foreign M.D. equivalent).
CTEP Investigator ID: Provide the unique CTEP investigator number assigned to the investigator by the Pharmaceutical
Management Branch (PMB), CTEP, DCTD, CTEP at the time of initial registration. (If an investigator has never registered
to participate in CTEP-sponsored clinical trials, leave field blank. An CTEP Investigator ID will be assigned by the
PMB as part of the registration process.)
Date of Birth: Indicate the investigator’s date of birth (in MM/YYYY format).
Provider No. (NPI): Indicate the investigator’s National Provider Identifier (NPI).
Medical License: Indicate if the investigator is currently licensed to practice medicine.
Primary Specialty Practice(s): Indicate the investigator’s primary specialty practice(s).
Board Eligibile: Indicate if the investigator is eligible for Board Certification in the primary specialty practice(s) selected.
Board Certified: Indicate if the investigator is Board Certified in the primary specialty practice(s) selected.
Investigator Training: Indicate if the investigator has completed the NIH-mandated training in the protection of human
research participants, including date completed (in MM/YYYY format). If needed, additional information and online training
are available at http://phrp.nihtraining.com . The online training takes approximately one hour to complete. Completion of
protection of human research participants training is mandatory for ALL CTEP-registered investigators.
Office Address: The office address will be used for receipt of all official correspondence (e.g., annual registration and
protocol documents). Include institution, internal office, street, city, state/province, zip/postal code, and country.
Office Phone No.: Provide daytime phone number at which the investigator can be reached during normal business hours,
including area code. Investigators from outside the United States should also include the country code.
Office Fax No.: Provide Fax number at which the investigator usually receives faxes, including area code. Investigators from
outside the United States should also include the country code.
Office E-mail: Provide E-mail address at which the investigator usually receives e-mail. This address will be used to send
information regarding protocols, investigator brochures, stock recovery letters, investigator expiry information, and general
information for the investigator.
Research Contact: Provide a phone number and email address, suitable for display on a publicly accessible website (e.g.,
www.cancer.gov), which can be used by a patient to contact the investigator’s research staff to inquire about clinical trials
approved by their IRB and open for enrollment at their institution.
Primary Shipping Address: The primary shipping address will be used for receipt of all CTEP-supplied investigational
agents. Include institution, internal office, street, city, state/province, zip/postal code, and country.
Shipping Designee: Provide name of shipping designee (preferably a pharmacist) approved to order and receive CTEPsupplied agents. Note that a “Clinical Drug Request (CDR) Form” for a CTEP-supplied agent must be signed by either
the investigator, the authorized shipping designee (from item #11), or an ordering designee (from item #12).
Shipping Designee Phone No.: Provide daytime phone number at which the shipping designee can be reached during
normal business hours, including area code. Shipping designees from outside the United States should also include the
country code.
Shipping Designee Fax No.: Provide Fax number at which the shipping designee usually receives faxes, including area
code. Shipping designees from outside the United States should also include the country code.
Shipping Designee E-mail: Provide E-mail address at which the shipping designee usually receives e-mail. This address
will be used to send information regarding drug shipments, protocols, stock recovery letters, and general information for
shipping designees.
Ordering Designee(s): Provide name(s) of ordering designee(s) approved to order CTEP-supplied agents. Note that a
“Clinical Drug Request (CDR) Form” for a CTEP-supplied agent must be signed by either the investigator, the
authorized shipping designee (from item #11), or an ordering designee (from item #12). An ordering designee must
use the primary shipping address (from item #11).
Ordering Designee Phone No.: Provide daytime phone number at which the ordering designee can be reached during
normal business hours, including area code. Ordering designees from outside the United States should also include the
country code.
Ordering Designee Fax No.: Provide Fax number at which the ordering designee usually receives faxes, including area
code. Ordering designees from outside the United States should also include the country code.
Ordering Designee E-mail: Provide E-mail address at which the ordering designee usually receives e-mail. This address
will be used to send information regarding drug shipments, protocols and general information for ordering designees.

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