The National Cancer Institute's Clinical Trials Cooperative Groups consist of researchers at member institutions who jointly develop and conduct cancer treatment clinical trials. Groups generate new trials based on their particular areas of interest and expertise, in conjunction with national priorities for cancer treatment research.

Cooperative Groups are diverse in their research objectives and their structures. There are three major types of Groups:

	Groups that are specifically disease oriented (e.g., gynecologic oncology)
	Groups specialize in specific types of interventions (e.g., radiation therapy, surgical therapy)
	Multimodality Groups that work in diverse cancer types with different specialists

All Groups are similar in that they develop and conduct large-scale, multi-site trials.

Most Cooperative Groups are also affiliated with NCI's Community Clinical Oncology Programs (CCOP) whose research teams are based in community hospitals and practice sites. The CCOP originated as an initiative to develop more cancer control research in community settings. The Division of Cancer Prevention (DCP) funds all CCOP institutions.

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Members of the site research team usually include at least one of the following: Principal Investigator, Clinical Research Associate (CRA) or Research Nurse, and Pharmacist. Each member of the study team has roles and responsibilities defined by the Code of Federal Regulations, Good Clinical Practice, and the Cooperative Groups. The CTSU adheres to these regulations and guidelines with several additional responsibilities regarding the reporting of data.

The National Institutes of Health (NIH) has mandated that all Investigators and research team members who apply for or receive NIH funds for research involving people must complete an educational offering on human subject protection. Each research team member must document completion of training in human subjects' protection and this documentation must be maintained at the site. An online continuing education program, Human Participant Protections Education for Research Teams, has been developed by the National Cancer Institute to fulfill this requirement. This course is available from the CTSU Registered Member Web Site or at: http://cme.nci.nih.gov.

The following sections describe the roles and tasks of various research team members or their designees. Though select tasks might be delegated to the CRA, Research Nurse, or Pharmacist, the Principal Investigator is ultimately responsible for the research conducted at the site.

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Principal Investigator

The Principal Investigator (PI) is responsible for the overall conduct of research activities at the site. The PI is expected to comply with the CFR and the International Conference on Harmonisation Guidelines for Good Clinical Practice (ICH/GCP). By signing the FDA 1572 Form, the PI agrees to:

	Submit the initial protocol to the local IRB.
	Submit all amendments to the local IRB.
	Comply with IRB continuing review requirements.
	Report promptly to the IRB all changes in research activity and all unanticipated problems involving risks to patients or others. No changes in the research are made without IRB approval except when necessary to eliminate apparent immediate hazards to patients, with IRB notification immediately following elimination of the hazard.
	Conduct study in compliance with the protocol requirements.
	Manage the oversight of data and materials submitted to the CTSU and Cooperative Groups.
	Inform all patients of the investigational nature of the study and ensure that the requirements for obtaining informed consent are met.
	Demonstrate understanding of the information in the investigator's brochure, including potential risks and side effects of the drug. Forward a copy of the investigator's brochure to the IRB and Pharmacist and ensure that it is maintained in a file with the site's regulatory documents.
	Ensure the accountability of NCI-supplied drugs.
	Maintain adequate and accurate records.

Note: See Section 9 of the FDA 1572 Form for complete information on investigator responsibilities. This form is located at this link: http://ctep.cancer.gov/forms/index.html.

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Clinical Research Associate or Research Nurse

A well-implemented protocol is often attributable to an organized, responsible CRA or Research Nurse. The PI may delegate some or all of the following tasks to the CRA or Research Nurse. With the PI's permission and under the PI"s guidance, this person may:

	Prepare regulatory documentation (IRB approval, IRB-approved informed consent, additional certifications defined in the protocol, etc.) required for protocol-specific site registration for submission to the CTSU.
	Assure that the study is conducted in compliance with protocol requirements.
	Maintain IRB correspondence and regulatory documentation.
	Recruit potentially eligible persons for participation in clinical trials.
	Meet with the patient interested in participating on the study to review the details of study enrollment.
	Evaluate whether a patient is eligible based on criteria presented in protocol.
	Assure that informed consent is obtained from the patient before initiating research-related activities.
	Develop strategies to retain study participants in the clinical trial.
	Schedule tests and appointments for patients within timeframes required by the protocol.
	Validate patient height and weight for accurate body surface area determination.
	Send the prescriptions for study agents to the Pharmacist.
	Complete Case Report Forms (CRFs) accurately, mail the originals to CTSU, and retain a copy in the CRF Notebook.
	Maintain source documentation for each study patient
	Instruct and educate patient regarding study treatment modalities and anticipated side effects and their management.
	Provide guidance to the Principal Investigator, Pharmacist, and patient on dose adjustment based on protocol dose modification section.
	Inform the Pharmacist about any dose changes.
	Collect and record returned study medication and monitor patient dosing compliance.
	Identify abnormal laboratory results, report these abnormalities to the PI if appropriate, and obtain repeat evaluations as required by the protocol.
	Identify, report to the PI, and document adverse events and serious adverse events.
	Initiates Serious Adverse Event Reports (SAEs) and obtain the PI's signature within the proper time frames, notify proper individuals stated in the protocol, and fax report to the CTSU.
	Respond to data queries from the CTSU in a timely manner.
	Contact the CTSU with questions regarding study implementation.

Note: The PI is held responsible for the research conducted at the site, even if select tasks are delegated to the CRA, Research Nurse, or Pharmacist.

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Pharmacist

The Pharmacist or designated qualified staff member is customarily accountable for the following:

	Study drug supply, storage, preparation, dispensation, and disposal or returns (per protocol).
	Records and ensures record security
	Retaining:
	Shipping receipts and return records NCI Drug Accountability Record Forms (DARFs) Transfer forms
	Medication administration record
	Maintenance of blinded study integrity
	Instruction to the care provider regarding the proper method of drug administration

Note: The PI is held responsible for the research conducted at the site, even if select tasks are delegated to the CRA, Research Nurse, or Pharmacist.

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Cancer patient advocates are devoted to supporting the common goal of improving the lives of those affected by cancer and eventually eliminating cancer altogether. A patient advocate can be a cancer survivor just completing treatment, one several years out of treatment, a person living a lifetime with cancer as a chronic illness, or one who has been affected by the disease through a friend or family member. Patient advocates often choose to become involved in cancer education, lobbying, and providing support to others affected by the same disease they experienced. Involvement in activities related to patient advocacy is diverse. Patient advocates work with health care professionals, industry professionals, legislators, and other cancer patients and their families in many different areas such as clinical trials, policymaking, fund raising, and support. They also work to educate other cancer patient advocates.

Patient advocates have become more prominent in the research arena. Advocates participate in research planning and review groups, including the National Cancer Institute's agenda-setting Progress Review Groups and the American Cancer Society's grant application review committees. The Department of Defense has advocates as voting members of review panels and the Food and Drug Administration has advocates on its advisory committee. In addition, NCI established the Director's Consumer Liaison Group (DCLG) that advises and makes recommendations to the Director from the perspective of cancer consumer advocates. The NCI has also developed the Consumer Advocates in Research and Related Activities (CARRA), a program designed to increase the involvement and effectiveness of patient advocates in NCI activities.

The CTSU works closely with numerous cancer patient advocacy groups. Many patient advocacy groups link to the CTSU on their web sites and circulate general articles about the CTSU to their membership. Patient advocates are invited to review CTSU materials and to offer suggestions for improving the operations of the CTSU. Patient advocates also assist sites implementing CTSU protocols by serving as liaisons between potential clinical trial participants and Investigators. They can help potential clinical trial participants make informed decisions by facilitating access to information about cancer clinical trials.

It is important for cancer patient advocates to understand the research process. Many advocates have taken the initiative to seek additional education in this area. Orientation and training is an integral part of the CARRA program at NCI. Other organizations such as the American Cancer Society and the Coalition of National Cancer Cooperative Groups (the "Coalition") have developed training programs for their advocates. Because of the availability of training programs, there is now a larger pool of knowledgeable advocates available for positions on research advisory boards, public policy committees, institutional review boards, and as publication reviewers.

To find out more about cancer patient advocacy, visit the Coalition's Patient Advocacy website at http://cancertrialshelp.org. The CTSU Public Website at http://www.ctsu.org/links.asp offers lists advocacy groups in the "Disease-Specific Resource Site" section. The CTSU public web site at http://www.ctsu.org/Patients_Page.asp, also links to patient advocacy organizations on the "Patients Page". Another helpful website is http://cancer.gov.

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