These guidelines provide information regarding preparation of correspondence and submission of all the required information/documentation. To expedite the approval process, please refer to the guidelines when preparing correspondence regarding organizational changes.

All correspondence related to organizational change(s), with the exception of change of Principal Investigator (see page 8) should be addressed to the Program Director assigned to your CCOP/MBCCOP and signed by the CCOP/MBCCOP Principal Investigator. When all documentation is complete, NCI program staff will respond with written response.
Please include your grant number in all correspondence.
Submission of all of the required information/documentation as indicated in the attached guidelines will greatly expedite approval. If you have questions or need copies of any of the forms/tables, please contact the Program Specialist or Analyst.
The Community Clinical Oncology Program is located in the Community Oncology and Prevention Trials Research Group (COPTRG), Division of Cancer Prevention (DCP), National Cancer Institute.

CCOP/MBCCOP Program Staff

NCI staff assigned to the CCOP/MBCCOP/MBCCOP Program:

Lori Minasian, MD, FACP, Chief, COPTRG
Joseph Kelaghan, MD, MPH, Program Director
Worta McCaskill-Stevens, MD, MS, Program Director
Christine Berg, MD, Program Director
Ann O'Mara, PhD, RN, Program Director
Barbara Dunn, PhD, MD, Program Director
Cynthia Whitman, Program Analyst
Dianne Gary, Program Specialist
Denise Boyer, Grants Technical Assistant

Telephone:

(301) 496-8541

Fax: (301) 496-8667

Mailing Address:

COPTRG, DCP, NCI, NIH
6130 Executive Boulevard, MSC-7340
Executive Plaza North, Room 2017
Bethesda, MD 20892-7340

Email questions to: Dianne Gary

Participating Physician

Please Include Your Grant Number in All Correspondence

CONSIDERATIONS BEFORE ADDING OR DELETING CCOP/MBCCOP PARTICIPATING PHYSICIANS

Before recommending new physicians to participate in the CCOP/MBCCOP, consideration should be given to identifying inactive Type A (accruing) physicians currently on the CCOP/MBCCOP roster. The CCOP/MBCCOP may wish to convert inactive Type A physicians to Type B (referring) physicians. This process may also identify physicians who can be deleted.
An average CCOP/MBCCOP has only 10 to 20 Type A physicians who actively accrue patients to clinical trials. NCI Program Directors will discourage long CCOP/MBCCOP rosters of physicians, particularly if many current physicians are inactive.
Prospective Type A physicians should acknowledge that participation in the CCOP/MBCCOP represents a commitment to continually place patients onto protocols.
A CCOP/MBCCOP should present a strong rationale to the Program Director before substantially increasing its total number of Type A physicians. The rationale should include a discussion of the distribution of physician accruals within the CCOP/MBCCOP.

TO ADD A PARTICIPATING PHYSICIAN

In a letter of request from the Principal Investigator to the appropriate Program Director, indicate that:

Human subjects protection training has been completed, date of completion and name of training provider; (you DO NOT need to include the training certificate);
The investigator has read the applicable assurance approved by the Office of Human Research Protection (OHRP) and a copy of the OHRP Assurance is on file in your CCOP/MBCCOP office (you DO NOT need to enclose the Assurance in your letter);
Approval from each of the CCOP/MBCCOP research base(s) has been, or is being, obtained, and the approval document(s) will be kept on file in your CCOP/MBCCOP office (you DO NOT need to enclose documentation in your letter).

Enclose only the following items with the letter:

CCOP/MBCCOP Participating Physician form signed by the new physician.

Note: The status of the applicant, i.e., Type A (accruing physician) or Type B (referring physician) must be provided. The information pertaining to Human Subjects Protection training also must be completed. Addition of a new Type A physician will NOT be approved without this information.
A complete curriculum vitae for each new physician, including state license number where physician is currently practicing and NCI Investigator number as indicated on the Participating Physician Form.

FDA FORM 1572

The Drug Management and Authorization Section (DMAS) requires they be notified of all new participating physicians. For accruing physicians who are directly responsible for patient care (i.e., Type A physicians), a FDA Form 1572 is also required. Others (i.e., Type B referring physicians or other health care workers) are not required to submit Form 1572.

Immediately after a new participating physician has been approved by the NCI, Program Director and all the CCOP/MBCCOP research bases, submit his/her name and address to the DMAS (address below). For Type A physicians, also submit the FDA Form 1572.
DO NOT submit FDA Form 1572 in your letter to the CCOP/MBCCOP Program Director. It should be submitted directly to the Pharmaceutical Management Branch.
Send physician's name, address, and Form 1572 (if appropriate) to:

Mr. Charles Hall
Chief, Pharmaceutical Management Branch
Drug Management and Authorization Section
CTEP, NCI, NIH
Executive Plaza North, Room 7149
6130 EXECUTIVE BLVD
ROCKVILLE, MD 20852 - (Note: Use for Courier deliveries)
BETHESDA, MD 20892-7422 (Note: Use for Regular Mail deliveries)

TO DELETE A PARTICIPATING PHYSICIAN

In a letter from the Principal Investigator to the appropriate Program Director, indicate:

the impact of the change on the CCOP/MBCCOP;
the participating physician has signed concurrence of deletion (or provide explanation of why the signature could not be obtained).

Notify all of the CCOP/MBCCOP's research base(s) of the change.

Component (To Add or Delete a Component)

Please Include Your Grant Number in All Correspondence

TO ADD A COMPONENT

In a letter from the Principal Investigator to the appropriate Program Director:

indicate the impact on CCOP/MBCCOP operations and how data management will be accomplished;
provide an applicable OHRP-approved assurance number for the institution with the Institutional Review Board (IRB) designated to conduct protocol reviews for the added component;
provide evidence that the component agrees to all the terms and conditions of award required of all CCOP/MBCCOP awardees (as stated in the CCOP/MBCCOP RFA).

Enclose the following items with the letter:

Tables 1 and 5, completed for the new component (see attached tables);
a consortium agreement signed by the component and the CCOP/MBCCOP applicant organization;
copy of agreement(s) between the CCOP/MBCCOP and each of its research base(s) to accept the added component;
a roster of Members of the designated IRB, in accordance with Department of Health and Human Services (DHHS) regulations;

If adding the component results in adding new physicians the guidelines for adding physicians also must be met.

TO DELETE A COMPONENT

In a letter from the Principal Investigator to the appropriate Program Director, indicate how the change will affect CCOP/MBCCOP operations. Letter(s) must be signed by:

Principal Investigator;
appropriate official from the component; and
appropriate official from the CCOP/MBCCOP grantee organization (identified on Notice of Award).

Notify the CCOP/MBCCOP's research base(s) of the change.

Affiliate (To Add or Delete an Affiliate)

Please Include Your Grant Number in All Correspondence

TO ADD AN AFFILIATE

In a letter from the Principal Investigator to the appropriate Program Director:

indicate the impact on CCOP/MBCCOP operations and how data management will be accomplished;
provide an applicable OHRP-approved assurance number for the institution with the Institutional Review Board (IRB) designated to conduct protocol reviews for the added affiliate;
provide evidence that the affiliate agrees to all the terms and conditions of award required of all CCOP/MBCCOP awardees (as stated in the CCOP/MBCCOP RFA).

Enclose the following items with the letter:

Table 2 and Table 5, completed for the new affiliate
copy of agreement(s) with the CCOP/MBCCOP's research base(s) to accept the added affiliate;
a Roster of Members of the designated IRB, in accordance with Department of Health and Human Services (DHHS) regulations;

TO DELETE AN AFFILIATE

In a letter from the Principal Investigator to the appropriate Program Director, indicate how the change will affect CCOP/MBCCOP operations. Letter must be signed by:

the Principal Investigator;
appropriate official from the affiliate; and
appropriate official from the CCOP/MBCCOP grantee organization (identified on Notice of Award).

Notify all the CCOP/MBCCOP's research base(s) of the change.

Research Base (To Add or Delete a Research Base)

Please Include Your Grant Number in All Correspondence

TO ADD A RESEARCH BASE

In a letter from the Principal Investigator to the appropriate Program Director, provide written documentation (e.g., affiliation agreement or letter from the research base) that agreement is acceptable to both the CCOP/MBCCOP and the research base.

TO DELETE A RESEARCH BASE

In a letter from the Principal Investigator to the appropriate Program Director:

indicate how the change will affect projected accrual and related activities of the CCOP/MBCCOP;
provide a signed concurrence from both the research base and the appropriate official from the CCOP/MBCCOP grantee organization (identified on Notice of Award).

Change of Applicant Organization As Listed on Grant Notice of Award

Please Include Your Grant Number in All Correspondence

If there is a change of the grantee's name or address as listed on the Notice of Grant Award (NGA), please contact your Grants Management Specialist (identified on your NGA) for information on procedures to follow.

New Principal Investigator (To Request a Change of the Principal Investigator)

Please Include Your Grant Number in All Correspondence

To request approval to change the Principal Investigator:

Address the letter requesting approval to change the P.I. to the Grants Management Specialist identified on your Notice of Award, NOT to the NCI Program Director assigned to your CCOP/MBCCOP.
Address for the Grants Management Specialist:

National Cancer Institute
Grants Administration Branch, DIR, NCI
6120 Executive Blvd
Executive Plaza South, Room 243
BETHESDA, MD 20892
Send a copy of the above letter and all enclosures to the NCI Program Director assigned to your CCOP/MBCCOP.

Please enclose the following items with your letter:

a letter/statement, signed by current Principal Investigator, relinquishing the responsibility;
a letter/statement, signed by the new Principal Investigator, indicating acceptance of the responsibility;
a curriculum vitae for the new Principal Investigator, which includes birth date, social security number, and license number in state where currently practicing;
documentation of concurrence of the CCOP/MBCCOP Grantee organization, identified on the Notice of Award.

The change becomes official only after the NCI Program Director indicates approval of the new Principal Investigator to the Grants Management Specialist and the Grants Administration Branch prepares a revised Notice of Award indicating the new Principal Investigator.

Other Administrative Changes

Please Include Your Grant Number in All Correspondence

Please notify the Program Analyst in writing regarding administrative changes such as:

a new administrator;
change of address, phone, or fax number; or
change/addition of an e-mail address

It is very important to notify the COPTRG of these changes so that notices, reports, and requests for information are directed to the appropriate individual in the CCOP/MBCCOP.