Resources for CCOPs and MB-CCOPs
Guidelines for Approval of Organizational Changes
All CCOP/MB-CCOP organizational changes require written approval from NCI program staff. Please include your grant number in all correspondence.
General Information for All Correspondence
All CCOP/MBCCOP organizational changes require written approval from NCI program staff.
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 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 send a 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 Dianne Gary.
- 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.
Back to Top
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
- Maria Sgambati, MD, Program Director
- Ann O'Mara, PhD, RN, Program Director
- Barbara Dunn, PhD, MD, Program Director
- Cynthia Whitman, Program Analyst
- Dianne Gary, Program Specialist
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
Back to Top
Participating Physician
Please Include Your Grant Number in All Correspondence.
Considerations Before Adding or Deleting Paritcipating 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.
Back to Top
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 (doc, 64.5kb) 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.
Back to Top
FDA FORM 1572
The NCI's Pharmaceutical Management Branch (PMB) 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 PMB (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 (PMB)
CTEP, NCI, NIH
Executive Plaza North, Room 7149
6130 Eexecutive Blvd
Rockville, MD 20852 - (Note: Use for Courier deliveries)
Bethesda, MD 20892-7422 (Note: Use for Regular Mail deliveries)
NOTE:DO NOT submit FDA Form 1572, Supplemental and Financial Disclosure Forms with the documents sent to the NCI Program Director to add a participating physician.
Back to Top
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.
Back to Top
Add or Delete a Component or Affiliate
Please Include Your Grant Number in All Correspondence
To ADD a Component or Affiliate
Documents/Information to Submit with request:
| Component | Affiliate |
|---|
| (1) Table 1 (doc, 52kb) and Table 5 (doc, 68kb) | (1) Table 2 (doc, 52kb) and Table 5 (doc, 68kb) |
| (2) Consortium agreement signed by the component and the CCOP/MB-CCOP applicant organization | (2) Not applicable |
| (3) Copy of agreement(s) with the CCOP/MB-CCOP research base(s) to accept the component | (3) Copy of agreement(s) with the CCOP/MB-CCOP research base(s) to accept the affiliate |
| (4) OHRP assurance number and the IRB designated to conduct protocol reviews for the component institution | (4) OHRP assurance number and the IRB designated to conduct protocol reviews for the affiliate institution |
| (5) A roster of members of the designated IRB | (5) A roster of members of the designated IRB |
|
To DELETE a Component or Affiliate
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.
Back to Top
To Add or Delete a Research Base
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)
Back to Top
Change of Applicant Organization As Listed on Grant Notice of Award
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.
Back to Top
New Principal Investigator (To Request a Change of the Principal Investigator)
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.
Back to Top
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.
Back to Top
