Volume 18, Issue 1, January 2007
     

The Changing Environment in Clinical Research: A Call for Action

Pat McLaughlin, RN, MSN, AOCN®
Cinnaminson, NJ
pmclaughlin9@verizon.net

The topic of the Clinical Trials Summit, held November 7–8 in Baltimore, MD, was clinical trials in crisis. Although major advances have been made in the past 5–10 years in the treatment and prevention of cancer, governmental funding for clinical research continues to be cut. Institutions receive an average of $2,000 per case for National Cancer Institute- (NCI-) sponsored trials, but in reality the costs of conducting these trials are $4,000–$6,000 (Lewin Group and Lovett-Collins Associates, 2006). Many CCOPs have had to decrease accrual by 10% (Benson, 2006). Ironically, the NCI has stated, “We will never know the true effectiveness of a cancer treatment or a way to prevent cancer unless more people are involved in clinical trials” (NCI, 2002).

The focus of the conference was on how to do more with less. Alterative statistical models were proposed. Attendees appeared to be in general agreement that the pharmaceutical industry, NCI, U.S. Food and Drug Administration, and Medicare and Medicaid are entities that need to work together to mitigate the negative impact of federal funding cuts on clinical trials. Although the budget was cut last year, the federal fiscal year 2007 funding has not been finalized and will not be determined until January 2007 after the new session of Congress convenes. The cuts are very upsetting, but we can do something about them—oncology nurses need to unite! ONS maintains a comprehensive health policy program, and advocating increased funding for the National Institutes of Health (NIH) and NCI and supporting access to clinical trials are key components of ONS’s advocacy efforts in Washington, DC. In fact, ONS operates ONStat, the ONS electronic grassroots network, which gives ONS members everything we need to be effective in calling on our elected officials to take action on our priorities. It’s easy to join—the only requirement is to be an ONS member in good standing for you to sign up. ONS makes it very easy by providing an online form at http://onsopcontent.ons.org/interactive/onstat/signup.aspx. In fact, the action alerts that ONS issues give you everything you need to weigh in with your elected officials—with a few clicks of your mouse, you can send a letter (ONS gives you one to use which you can personalize if you like) just by typing in your zip code! I encourage everyone in our SIG to join ONStat today. It is time to let our elected officials know what we want done with the tax dollars we pay!

I believe that being proactive is much more effective than reactive. Let’s not wait until we hear that the budget is cut yet again in the area of clinical research. Instead, let us unite as an 800-member–strong SIG by joining ONStat and coming together with the more than 4,300 other ONStat members to call on Congress to boost funding for NIH, NCI, and other federal agencies that support research and the nursing community. We need to inform our members of Congress in Washington how their decisions and funding allocations impact our patients and our work. Unless they hear from us, we cannot presume that they have all the facts. We need to share stories of success and opportunity. Saying that we support research and that we are patient advocates is easy. Now is the time to put our words into action.

References
Benson, A.D. (2006, November). Crisis in funding clinical trials: The nursing perspective. Presentation at Summit Series on Cancer Clinical Trials X: Clinical Trials in Crisis, Baltimore, MD.

The Lewin Group & Lovett-Collins Associates. (2006). Enhancing cancer treatment through improved understanding of the critical components, economics, and barriers of cancer clinical trials, 2006.C-Change and the Coalition of Cancer Cooperative studies.


National Cancer Institute. (2002). Cancer clinical trials: The basic workbook. Retrieved June 26, 2006, from http://www.cancer.gov/PDF/091e02f3-5bb9-4ba6-a988-9ad35eab6a61/BasicsWorkbook_m.pdf

  
The Clinical Trial Nurses SIG Newsletter is underwritten by a grant from the Lance Armstrong Foundation.

Special Interest Group Newsletter  January 2007
 
   

Adverse Events Must Be Monitored and Reported in Clinical Trials

Elizabeth Ness, RN, MS
Bethesda, MD
nesse@mail.nih.gov

Adverse event (AE) monitoring and reporting is a routine part of every clinical trial and is critical to the safety of all subjects enrolled in a study and any future studies using similar agents or treatment regimens. AE is a broad-based term that is applicable to many types of medical situations, including research. In the clinical trials setting, an AE is defined as “any unfavorable or unintended sign (including abnormal laboratory finding), symptom, or disease having been absent at baseline, or, if present at baseline, appears to worsen, and has a temporal association with a protocol treatment or procedure regardless of attribution” (International Conference on Harmonisation, 1996).

The purposes of AE reporting include

  • Monitoring events related to the study treatment
  • Identifying events that may have an immediate effect on the safety of study subjects
  • Informing regulators, investigators, and others of new and important information on serious reactions that occur on a clinical trial

  • Providing a summary of adverse experiences to develop the drug toxicity profile.

Assessment
AEs are assessed by the principal investigator or designee (member of the research team), and assessment includes determining the following.
  • Severity of event(s)
  • Expectedness of event(s)
  • Relationship to protocol treatment
Based on the assessment, the principal investigator or clinical trial nurse can determine the timeliness for reporting of events to the institutional review board, sponsor, or other regulatory or oversight groups.

Severity of the event
In oncology clinical trials, severity assessment is done using a standard language and dictionary called the Common Terminology Criteria for Adverse Events (CTCAE).

Expectedness of the event
Any AE is considered expected if it is listed in the current labeling for the drug or product (package insert or investigator’s brochure), protocol, or informed consent document.

Relationship to protocol treatment
The principal investigator or coinvestigators determine the relationship of the event to the study therapy. Attribution information assists regulatory or oversight groups to assess safety and protection for human subjects. For investigational agents, the attribution also will assist the sponsor in determining whether or not the event requires expedited reporting to the U.S. Food and Drug Administration (FDA). Typically, attribution options include

  • Definite: clearly related
  • Probable: likely related
  • Possible: maybe related
  • Unlikely: doubtfully related
  • Unrelated: clearly not related.
The following questions will assist in determining the attribution for an event.
  • Is the event a known reaction for the therapy or drug?
  • Does a temporal relationship exist between the event and treatment?
  • Does the event improve or disappear when treatment is stopped?
  • Does the event reappear when subject is rechallenged with the drug or therapy?
  • Can the event be reasonably explained by clinical disease?
  • Is the event a worsening of baseline symptom(s)?
  • Could any concurrent medications be involved in causing or contributing to the event?
Documentation and Recording of Adverse Events
Documentation of AEs always will be noted in a source document (e.g., medical record, clinic chart, hospital chart). Recording of the AEs (abstraction) onto a case report form (CRF) is dependent on the protocol (i.e., a protocol may not require recording grade 1 events, whereas others will require recording all events). A subject’s medical record must include all adverse events, and for each event, at a minimum the following should be documented.
  • Onset and resolution dates of event

  • Treatment for the event, if any, including hospitalization

  • Severity or grade of the event

  • Relatedness or attribution of the event to the research (study medications or procedures).

Information abstracted from a subject’s medical record to the CRF includes

  • Onset and resolution dates of event

  • Treatment for the event, if any, including hospitalization

  • Severity or grade of the event

  • Relatedness or attribution of the event to the research (study medications or procedures)
Expedited Adverse Event Reporting
A subset of AEs needs to be submitted to regulatory or oversight groups (e.g., institutional review board, sponsor, FDA, Office of Biotechnology Activities) in an expedited manner based on severity, expectedness, and seriousness. Expedited reporting often is referred to by many aliases, including serious AE (SAE), serious adverse experience, expedited AE, or adverse drug reaction.

To determine whether expedited adverse event reporting is required, nurses must understand the following two definitions. These definitions, along with the attribution, will drive the reporting requirements for various regulatory or oversight groups.

  • A SAE (U.S. Food and Drug Administration, Department of Health and Human Services, 2006) is any AE occurring at any dose that results in any of the following outcomes.
    • Death
    • Life-threatening adverse drug experience

      •
    • Inpatient hospitalization or prolongation of existing hospitalization

    • Persistent or significant disability or incapacity

    • Congenital anomaly or birth defect
      •

    Additionally, an event may be considered serious if it doesn’t result in death, if it isn’t life-threatening, or if it doesn’t require hospitalization but may jeopardize a subject or require medical or surgical intervention to prevent one of the previously mentioned outcomes.

  • An unexpected AE is any adverse experience that is not listed in the current labeling for the drug or product (package insert or investigator’s brochure). This includes events that may occur at a greater severity than those listed in the labeling.
    •

Serious versus severe
The decision to report an adverse event to a regulatory or oversight group is dependent on understanding the difference between serious and severity. Serious is based on outcome and is a factor in determining reportability (e.g., subject hospitalized as result of event), whereas severity refers to the intensity of the experience (i.e., CTCAE grade).

Expedited reporting requirements
Events to be reported to various regulatory or oversight groups in an expedited manner must be defined in the protocol, including the time line for reporting. Each group will have their own form to be used for reporting. This often is referred to as the SAE form.

Institutional review board: Nurses should know what their institutional review board’s requirements are for expedited AE reporting and what type of form or cover memo will be used for an expedited submission.

Sponsors: Sponsors may cast a broader net when defining AEs that are to be reported to them in an expedited manner. The definitions may not be the same as the institutional review boards’ or other groups’. Nurses will need to familiarize themselves with all their various sponsors’ requirements and their report forms.

FDA: (See the related article on Investigative New Drug Safety Reporting.) The FDA has two types of expedited reports: a seven-day report and a 15-day report. The sponsor is responsible for submitting reports. (Note: If the investigator is a sponsor-investigator, then he or she is responsible for reporting to the FDA.) Typically, an FDA Mandatory MedWatch form 3500a is used (www.fda.gov/medwatch/SAFETY/3500A.pdf).

  • Seven-day report: Any unexpected and fatal or life-threatening experience associated with the use of the investigational agent is to be submitted to the FDA in seven days of the sponsor being notified of the events. Notification can be by phone, fax, or e-mail and must be followed by a written report.
  • 15-day report: All AEs that are serious and unexpected associated with the use of an investigational agent are to be submitted, in writing, in 15 days of the sponsor being notified of the events.

Office of Biotechnology Activities: Studies that involve recombinant DNA and human gene transfer also will need to report to the Office of Biotechnology Activities. Reporting requirements are the same as the FDA: seven-day and 15-day. The site is responsible for reporting to Office of Biotechnology Activities. The report form is available at the office’s Web site at http://www4.od.nih.gov/oba/RAC/Adverse_Event_Template.doc. Some studies may be registered for electronic submission via GemCRIS.

Expedited reporting forms:
Although expedited report forms may be different, they all have similar key components.

  • Reporter information

  • Subject demographics

  • Study agent
    • (date(s) given, dose, route of administration)
  • Event

  • Attribution

  • Narrative summary

  • Investigator signature.

The narrative summary is the most important part of the report. The recipient of the form likely does not know anything about the subject and his or her history, so nurses should provide enough background information to support the attribution and grade of the event. The narrative summary should include

  • Information that helps to describe the event(s)

  • Information that puts the event in perspective (relevant subject history)

  • Underlying medical conditions

  • Prior surgeries or procedures

  • Family history (only if it applies to the event)

  • Recent events that may be a contributing factor

  • Concomitant medications that may be a contributing factor
    • .

Words of caution for expedited reporting
The FDA and Office of Biotechnology Activities are looking for an attribution as it relates to an investigational drug or product. The institutional review board is looking for an attribution as it relates to the research. Sponsors may use either attribution relationship (drug or research). This means that an event that may be reported to a sponsor may not necessarily be reported to the institutional review board and vice versa.

General reminders

  • Because expedited events are a subset of AEs, all information captured on an expedited event form must be present in the source documents and be found on the AE CRF.
  • Some events initially may appear to meet expedited reporting requirements but are excluded from expedited reporting as per the protocol. The protocol trumps all other reporting requirements.

  • All expedited report forms and responses from the regulatory or oversight group are to be placed in the regulatory binder.

Limited information in expedited reporting
Occasionally, only a limited amount of information about a potential expedited adverse event is known. The list below offers some tips on handling limited information.

  • Contact the treating physician or institution, and document all conversations in the medical record.

  • Submit what you have—the most recent clinical evaluation, baseline history, and physical examination.

  • Provide a plan for obtaining information.

  • Provide a summary of the event and treatment to date.

  • When additional information becomes available, amend the report.


References
International Conference on Harmonisation. (1996). Guidelines for good clinical practice. Retrieved December 8, 2006, from http://www.ich.org/LOB/media/MEDIA482.pdf

U.S. Food and Drug Administration, Department of Health and Human Services. (2006). Title 21 Code of Federal Regulations Part 312: Investigational new drug application. Retrieved December 14, 2006, from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=312

Bibliography
Ginsberg, D. (2002). The Investigator’s Guide to Clinical Research (3rd ed.). Boston: Thompson, Centerwatch.

National Cancer Institute Cancer Therapy Evaluation Program. (2003). Common terminology criteria for adverse events, version 3.0. Retrieved December 8, 2006, from http://ctep.cancer.gov/reporting/ctc_v30.html

National Institutes of Health. (n.d.). Office of Human Subjects Research website. Retrieved December 8, 2006, from http://www.nihtraining.com/ohsrsite

National Institutes of Health. (2002). Guidelines for research involving recombinant human DNA molecules. Retrieved December 8, 2006, from http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html

Woodin, K.E., & Schneider, J.C. (2003). The CRA’s guide to monitoring clinical research. Boston: Thompson, Centerwatch.

 
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Special Interest Group Newsletter  January 2007
 
   

Investigational New Drug Safety Reports Act as Safety Alerts

Elizabeth Ness, RN, MS
Bethesda, MD
nesse@mail.nih.gov
An Investigational New Drug (IND) Safety Report (ISR) is a written report from an IND sponsor to the U.S. Food and Drug Administration (FDA) and all participating investigators describing an adverse experience(s) associated with use of an IND that is serious and unexpected. It also can be a written report of any findings from continuing animal studies that suggest a significant risk for human subjects (teratogenicity, mutagenicity, or carcinogenicity). Typically, ISRs are written as safety alerts in between revisions of the investigator’s brochure for an IND. The timeline for filing an ISR to the FDA is based on the 7-day and 15-day reporting requirements.
  • 7-day report: Any unexpected and fatal or life-threatening experience associated with the use of the investigational agent is to be submitted to the FDA in seven days of the sponsor being notified of the events. Notification can be by phone, fax, or e-mail and must be followed by a written report.

  • 15-day report: All adverse events that are serious and unexpected associated with the use of an investigational agent are to be submitted, in writing, in 15 days of the sponsor being notified of the events.

Typically an ISR includes a summary of dosing, event(s), treatment of event(s), attribution, a summary of all previously filed ISRs concerning similar events, and an analysis of the significance of the event(s) in light of previous ISRs.

The case report form states, “The sponsor shall notify FDA and all participating investigators in a written IND safety report.” (Note: For Cancer Therapy Evaluated Program– (CETP-) sponsored multicenter trials, CTEP sends the ISR to the FDA and the appropriate study principal investigators. CTEP will not send to all investigators. The study principal investigators are responsible for sending to all participating investigators.)

The following is a list of steps that the site can follow, once the PI receives the ISR, to ensure regulatory compliance.

  • The principal investigator reviews the ISR.
  • The principal investigator assesses the need to amend the study’s protocol or consent and sends the ISR to subinvestigators and clinical trial nurses.
  • In some situations, the sponsor’s or the principal investigator’s assessment of the ISR may result in having all patients stop using the study drug immediately and may require immediate follow-up with laboratory tests and physical examinations.
  • The principal investigator or clinical trial nurse sends the ISR to the institutional review board with a cover memo indicating the need to amend the protocol or consent. (Note: Some institutional review boards do not receive the ISR. Nurses should know their institutional review board’s standard operating procedure concerning ISRs.)
  • The principal investigator or clinical trial nurse informs currently enrolled patients immediately (i.e., by phone) of new potential risk and discusses each patient’s option to continue or withdrawal from study. The conversation and patient decision is documented in the patient’s medical record.
  • The principal investigator or clinical trial nurse places the ISR in the regulatory binder, including the institutional review board review and comments.
  • The principal investigator amends the protocol or consent.
  • Currently enrolled patient(s) must give new consent as guided by the institutional review board.

Bibliography
International Conference on Harmonisation. (1996). Guidelines for good clinical practice. Retrieved December 8, 2006, from http://www.ich.org/LOB/media/MEDIA482.pdf

U.S. Food and Drug Administration, Department of Health and Human Services. (2006). Title 21 Code of Federal Regulations Part 312.322: IND Safety Reports. Retrieved December 14, 2006, from http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=312.32


 
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Special Interest Group Newsletter  January 2007
 
   

Learn the History of the Common Terminology Criteria for Adverse Events

Maureen Edgerly, RN, MA, OCN®, CCRC
Bethesda, MD
edgerlym@mail.nih.gov

In 1982, the National Cancer Institute’s (NCI’s) Cancer Therapy Evaluation Program (CTEP) developed the Common Toxicity Criteria (CTC) v1.0 for use in

  • Reporting adverse drug experiences (AEs)
  • Summarizing study AEs
  • Investigational new drug (IND) reports to the U.S. Food and Drug Administration (FDA)
  • Publications.
The original version of the CTC was divided into 18 categories and 49 AE terms with criteria for grading the severity of each term. Over time, individuals and groups made revisions to the criteria, resulting in nonconformity among and between NCI cooperative groups and others. Eventually, in 1997, a CTC review committee was formed to review, revise, and expand the CTC. In 1998, the CTC v2.0 was released. This was a long-awaited improvement to the original CTC. Version 2.0 contained 24 categories and more than 250 AE terms. Appendices containing the Radiation Therapy Oncology Group/European Organization for the Research and Treatment of Cancer Late Radiation Morbidity Scoring Scheme and the Bone Marrow Transplant Complex/Multicomponent Event Scheme were added. The NCI CTC v2.0 became the worldwide standard dictionary for reporting acute AEs in cancer clinical trials and has been translated into several languages.

Despite the vast improvement from CTC v1.0 to 2.0, a need for enhancement and expansion of the criteria still existed. CTEP and NCI convened another team to review the criteria with the goals of creating a comprehensive dictionary of AE terms that included all modalities used in the treatment of cancer. Many additional criteria relevant to surgery, radiation, and pediatrics were added. The outcome was the 2003 publication of the NCI Common Terminology Criteria for Adverse Events (CTCAE) v3.0. The term “toxicity” was replaced by “terminology” to emphasize that the severity scale was not intended to imply an attribution to the research.

The following four categories were added to the CTCAE v3.0, bringing the total number of categories to 28 and the number of AE terms to more than 900.

  • Death
  • Growth and development
  • Surgery/intraoperative injury
  • Vascular
Several categories were deleted from CTCv2.0 when the CTCAE v3.0 was created. Others were split into separate events, and some terms were merged. For a complete explanation of CTCAE, please refer to the CTCAE Web site.

Studies written before 2003 were assigned to the CTC v.2.0 for AE grading and reporting so that all the data were consistent. All NCI-sponsored studies (and most industry-sponsored studies) approved after March 2003 were assigned to the CTCAE v3.0.

The pocket version of CTCAE v3.0 is available from the NCI. You may order a copy online at www.cancer.gov—click on “NCI publications,” click on “Search for publications,” and type in key word CTCAE. You also may download PDF versions at http://ctep.cancer.gov/reporting/ctc_v30.html. The download and other materials related to CTC v2.0 and CTCAE v3.0 are available at http://ctep.cancer.gov—click on “CTCAE v3.0” or “CTCAE/CTC Archive.” Keep in mind that several versions have been released since March 2003, so if you already have a pocket version, note the date published and refer to the NCI Web site for updates since your version was released.

The International Conference on Harmonization develops requirements for drug regulatory reporting globally and has chosen MedDRA (Medical Dictionary for Regulatory Activities) terminology to be the standard. To facilitate data transfer to the FDA and other regulatory agencies, NCI maps all CTCAE v3.0 terms to the MedDRA version currently used by CTEP. In the case where appropriate MedDRA codes for CTCAE terms do not exist, provisional codes, beginning with the number 9, are assigned by CTEP.

Bibliography
National Cancer Institute Cancer Therapy Evaluation Program. (2006). Common terminology criteria for adverse events v3.0. Retrieved December 8, 2006, from http://ctep.cancer.gov/reporting/ctc_v30.html

National Cancer Institute Cancer Therapy Evaluation Program. (n.d.). Common terminology criteria for adverse events v3.0—Online instructions and guidelines. Retrieved December 8, 2006, from https://webapps.ctep.nci.nih.gov/webobjs/ctc/webhelp/welcome_to_ctcae.htm

 
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Special Interest Group Newsletter  January 2007
 
   

NCI Corner
Help Your Patients Learn About Clinical Trials

Rosemary Padberg, RN, MA
Bethesda, MD
rp65s@nih.gov

Sona Thakkar, MA
Bethesda, MD
thakkars@mail.nih.gov
In the last edition of the NCI Corner, we introduced the National Cancer Institute’s (NCI’s) Clinical Trials Education Series, a complete collection of more than 20 multimedia educational resources about cancer clinical trials. In particular, we highlighted a series of workbooks designed for healthcare professionals and other individuals who are seeking an understanding of clinical trials.

In this edition, we feature resources designed for patients, family members, and community groups. These patient education resources are designed to help your patients make informed decisions about participation in cancer clinical trials. Each of the patient resources is described below (* indicates availability in Spanish).

Brochures
If You Have Cancer: What You Should Know About Clinical Trials* is designed for patients considering participation in a clinical trial. This easy-to-read resource explains what cancer clinical trials are, describes the benefits and risks of clinical trials, and provides patients with questions to ask before participating in clinical trials.

If You Have Cancer and Have Medicare. . . You Should Know About Clinical Trials is for Medicare recipients who have cancer. It provides general information about cancer clinical trials, Medicare coverage, and questions to ask before joining a clinical trial.

If You Want to Find Ways to Prevent Cancer . . . Learn About Prevention Clinical Trials* is an easy-to-read brochure that explains the basics of cancer prevention trials. It also provides the benefits and risks of prevention clinical trials and questions to ask before joining a trial.

Providing Your Tissue for Research: What You Need to Know describes what tissue is and how research with tissue can help prevent and treat diseases such as cancer, diabetes, and Alzheimer.

Booklets
Taking Part in Clinical Trials: What Cancer Patients Need to Know* defines clinical trials, discusses what patients might expect if they participate in a trial, and things to think about when deciding to participate.

Taking Part in Clinical Trials: Cancer Prevention Studies: What Participants Need to Know* provides information about cancer and cancer prevention clinical trials. It helps people decide whether participating in a prevention trial is right for them.

Videos
Cancer Trials. . . Because Lives Depend on It discusses prevention and treatment clinical trials to create general awareness about them. The video is 10 minutes long and includes a discussion guide.

Cancer Clinical Trials: An Introduction for Patients and Their Families discusses treatment clinical trials for patients and their families who may be considering participation. The video is 18 minutes long and includes a discussion guide.

To order any of these resources, call 800-4-CANCER or go to www.cancer.gov/publications. You also can visit to download promotional materials about NCI’s clinical trials education www.ncipoet.org resources.

 
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Special Interest Group Newsletter  January 2007
 
   

Upcoming Workshop Focuses on Genetics

Genetics and Genomics: A Workshop for Oncology Nurses, May 2–3, 2007
Location: Lister Hill Auditorium, National Institutes of Health, Bethesda, MD
Sponsor: Center for Cancer Research, National Cancer Institute
Fee: No registration fee
Registration site: www.cancermeetings.org/genetics
Contact hours: 16.7 contact hours will be awarded for two-day attendance.

 
 
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Special Interest Group Newsletter  January 2007
 
   



Lance Armstrong Foundation Underwrites Newsletter

Pat McLaughlin, RN, MSN, AOCN®, CCRP
Cinnaminson, NJ
pmclaughlin9@verizon.net

The Lance Armstrong Foundation has graciously offered to underwrite the next three issues of the Clinical Trial Nurses SIG Newsletter. I believe that this clearly demonstrates Lance Armstrong’s commitment to clinical research and that he values the work we do. I urge you to take a few minutes and send a letter thanking the foundation for its support. Please address it to Mitch Stoller, president and executive director, P.O. Box 161150, Austin, TX 78761-1150.
 
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Special Interest Group Newsletter  January 2007
 
   

The Clinical Journal of Oncology Nursing Is Looking for New Writers and Expert Mentors

Do you know of an oncology topic that needs to be addressed from your perspective as a direct caregiver, but the thought of developing a manuscript overwhelms you? Are you an experienced author with expertise in writing for publication and a willingness to mentor?

If so, the Clinical Journal of Oncology Nursing (CJON) Mentor/Fellow Writing Program is for you. We are seeking direct caregivers who have a desire to write for publication and experienced authors who are willing to offer them guidance and support. As many as 10 direct caregivers will be selected to participate. Each selected applicant will be paired with a mentor, who will guide the novice writer through the manuscript preparation process. Six months will be allotted to complete and submit the manuscripts to the CJON editor. All manuscripts will undergo the standard CJON peer-review process. Accepted manuscripts will be published in an issue of CJON. Each mentor/fellow pair will be allotted a budget to cover telephone and postage expenses. Each mentor will receive an honorarium when the completed manuscript is submitted and be given second authorship on the manuscript.

For more information or to obtain an application, visit the Publications area of the ONS Web site (www.ons.org) or contact Laura Schnable, ONS Publishing Division administrative assistant, at 412-859-6271 (pubCJON@ons.org). Applications are due February 15, 2007.

 
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Special Interest Group Newsletter  January 2007
 
   

Membership Information

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Join a Virtual Community

A great way to stay connected to your SIG is to join its Virtual Community. It’s easy to do so. All you will need to do is
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Participate in Your SIG’s Virtual Community Discussion Forum
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Special Interest Group Newsletter  January 2007
 
   

Clinical Trial Nurses SIG Officers

Coordinator (2006–2008)
Pat McLaughlin, RN, MSN, AOCN®
Voorhees, NJ
pmclaughlin9@verizon.net

Ex Officio (2006–2007)
Joan Westendorp, RN, MSN, OCN®, CCRA
Kalamazoo, MI
jwestendorp@wmcc.org

 		  Editor
Maureen Edgerly, RN, MA,OCN®, CCRC
Bethesda, MD
edgerlym@mail.nih.gov

ONS Publishing Division Staff
Elisa Becze, BA
Pittsburgh, PA
ebecze@ons.org

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ONS Membership/Leadership Team Contact Information

Angie Stengel, MS, CAE, Director of Membership/Leadership
astengel@ons.org
412-859-6244

Diane Scheuring, MBA, CMP, Manager of Member Services
dscheuring@ons.org
412-859-6256

Carol DeMarco, Membership/Leadership Administrative Assistant
cdemarco@ons.org
412-859-6230

The Oncology Nursing Society (ONS) does not assume responsibility for the opinions expressed and information provided by authors or by Special Interest Groups (SIGs). Acceptance of advertising or corporate support does not indicate or imply endorsement of the company or its products by ONS or the SIG. Web sites listed in the SIG newsletters are provided for information only. Hosts are responsible for their own content and availability.

Oncology Nursing Society
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Pittsburgh, PA 15275-1214
866-257-4ONS
412-859-6100
www.ons.org

 
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