Form 2 Supplemental Investigator Data Form

SUPPLEMENTAL INVESTIGATOR DATA FORM Date (MM/DD/YYYY):

___/___/_______

Sections 1 – 12: REQUIRED INFORMATION (Collected for all investigators participating in NCI-sponsored clinical trials.)

1. Investigator Name (Last, First, Middle, Suffix):

2. Degree(s):

3. NCI Investigator No.:

4. Date of Birth (MM/YYYY): __ __ / __ __ __ __

5. Provider No. (NPI):

6. Are you currently licensed to practice medicine? YES NO

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

Board Eligible:

Board Certified:

Board Eligible:

Board Certified:

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:

Completion of this training is mandatory for all NCI-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, 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.:

_________________________________________

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:

____________________________________

_______________________________________________________________________

_____________________________________________________________________

NCI 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. Ordering Designee Name:

____________________________________

A. 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:

__________________________________

B. Ordering Designee Name:

____________________________________

B. 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:

__________________________________

C. Ordering Designee Name:

____________________________________

C. 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:

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

Section	INSTRUCTIONS FOR COMPLETING THE “SUPPLEMENTAL INVESTIGATOR DATA FORM”
1.	Investigator Name: Provide legal last name, first name, middle initial or name, and suffix (if applicable).
2.	Degree(s): Provide degree(s) (e.g., M.D., D.O., foreign M.D. equivalent).
3.	NCI Investigator No.: Provide the unique NCI investigator number assigned to the investigator by the Pharmaceutical Management Branch (PMB), CTEP, DCTD, NCI at the time of initial registration. (If an investigator has never registered to participate in NCI-sponsored clinical trials, leave field blank. An NCI Investigator No. will be assigned by the PMB as part of the registration process.)
4.	Date of Birth: Indicate the investigator’s date of birth (in MM/YYYY format).
5.	Provider No. (NPI): Indicate the investigator’s National Provider Identifier (NPI).
6.	Medical License: Indicate if the investigator is currently licensed to practice medicine.
7.	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 selected. Board Certified: Indicate if the investigator is Board Certified in the primary specialty practice selected.
8.	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 NCI-registered investigators.
9.	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.
10.	Research Contact: Provide a phone number, 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.
11.	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 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). 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 protocols, stock recovery letters, and general information for shipping designees.
12.	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 protocols and general information for ordering designees.