Multisite Research Initiatives

Multisite Research Strategic Plan Progress Report - 2008

Core Competencies in Multisite Research

Overview
The Oncology Nursing Society (ONS) 2006-2008 Multisite Research Strategic Plan is designed to engage nurses in the multisite research process and accelerate translation of research findings into practice. This strategic plan was initiated in part because of the growing number of oncology nursing multisite studies and because the National Institutes of Health Roadmap Initiative is charting new directions for clinical research with a specific directive to enhance efficiency, productivity, and generalizability of research findings via the conduct of multisite research (Office of Portfolio Analysis and Strategic Initiatives, 2006). Despite the movement toward conducting multisite research, little information is available in the literature regarding the individual knowledge, skills, and abilities necessary for nurse scientists to conduct such studies. A specific goal of the ONS Multisite Research Strategic Plan is to develop core competencies for the conduct of multisite research for nurse scientists.

Definitions

Multisite research is a study conducted by a consortium of one or more investigators using the same overall research plan at several different local, regional, national, or international sites. Data are pooled for analyses to accomplish the specific aims of the study, and results are disseminated by the consortium of investigators (ONS, 2004).

Core competencies are those requisite abilities or qualities needed by nurse scientists, as principal investigators, to assume responsibility in conducting multisite research. Specific tasks may be delegated to research staff, such as study coordinators, who have the required knowledge, training, skills, and abilities to carry out the responsibilities.

Organizing Framework
A framework for organizing the core competencies was developed as a means to ensure that the competencies

  • Fit within a larger conceptual overview of considerations specific to multisite research
  • Provide a comprehensive outline of abilities and qualities within each aspect of the framework
  • Enhance understanding, preparation, and engagement with multisite research.

Leadership in multisite research is a central competency needed for nurse scientists to design and guide all processes and activities of multisite research studies. Leadership is demonstrated in a person's communications, strategic planning, and ongoing coordination of individuals, groups, and activities. Leadership involves ensuring that the study progresses in a timely, efficient, rigorous, and effective manner toward its goals and objectives.

Key process areas in multisite research encompass specific areas of activities within which competency is needed to appropriately carry out a multisite research study. Key process areas include the following.

  • Operational implementation: Design and oversight of resources, operations, and procedures necessary to conduct research across more than one site and ensure the reliability and validity of study procedures
  • Subject participation: Recruitment, enrollment, adherence, and retention of study participants
  • Data management : Organization, entry, storage, processing, and security of data collected in the study
  • Fiscal management : Planning, spending, and reconciling budgets
  • Dissemination and translation: Advancing scholarly and scientific contributions from the study (e.g., publications, presentations, ancillary or substudies)

Each key process area addresses two specific challenges in multisite research-standardization and regulatory compliance-to ensure that both site-specific and studywide efficiencies and needs are considered on an ongoing basis.

  • Standardization involves maintaining a focus on study rigor, reliability, and validity, as well as on efficient operations.
  • Regulatory compliance addresses the importance of adhering to federal, state, local, and institutional regulations, requirements, licensures, and review boards.

In order to meet the challenges of conducting multisite research, inherent within each of the core competencies is the need to ensure that relevant policies, procedures, and systems are

  • Developed
  • Documented in official study materials
  • Distributed to research teams
  • Implemented after training
  • Tracked inreal time
  • Monitored regularly
  • Evaluated against established performance criteria/objectives
  • Revised, if needed

  • Archived, for future reference.

LEADERSHIP IN MULTISITE RESEARCH

  • Develop a design and methods for the multisite research study that are appropriate to the research questions and hypotheses.
  • Identify investigators and sites that have the appropriate experience, resources, capability, and availability of potential subjects to carry out the study.
  • Clearly articulate in writing and verbally the vision for the study, specific aims, and scientific rationale to ensure investigator and staff commitment, follow-through, and appropriate study implementation.
  • Establish a study leadership team to implement the key process areas (see Organizing Framework), provide mentorship as appropriate, and discuss and problem-solve scientific issues as the study evolves.
  • Establish and maintain standards for clear, timely, and collaborative communications, consensus-building, and information-sharing in order to build a team within and across sites.
  • Enhance relationships with investigators and staff by building trust, providing compelling rationale for decisions, and ensuring consistent and timely follow-through.
  • Facilitate study progress by building on everyone's strengths, minimizing weaknesses, and appreciating diversity among investigators and staff (including differences in experience, geographic locations, and institutional policies).
  • Identify and support investigators and staff taking on studywide (i.e., across sites) leadership roles and responsibilities as the study evolves.
  • Establish relationships and/or contracts with appropriate institutions, groups, or individuals to provide centralized support to enhance efficiency of study activities, such as data management and statistical analysis, specimen handling and analysis, and distribution of materials and supplies.
  • Build and maintain interdisciplinary relationships among study investigators and staff that support credibility, mutual respect, and professional development.

 

OPERATIONAL IMPLEMENTATION

Standardization

  • Develop a study manual that is consistent with the protocol, is available to all relevant staff, and includes standard operating procedures for carrying out study activities.
  • Develop systems for centrally handling and distributing materials used by study sites (e.g., supplies, medications, intervention materials, standard documents).
  • Develop systems for collecting, processing, and handling blood and tissue specimens in ways that maximize their scientific utility.
  • Develop systems that support communication among sites (e.g., conference calls, newsletters, procedural bulletins/alerts) to facilitate information sharing and study updates.
  • Develop standardized procedures for ongoing data, procedural, and intervention quality assurance at multiple levels (e.g., studywide, at each site, by individual staff).
  • Develop procedures to standardize and track eligibility determination, study enrollment/registration, and randomization to study arms.
  • Develop systems for initial and ongoing training (central and/or local, as needed) to ensure standardized performance of study procedures across all sites.

Regulatory Compliance

  • Develop systems to ensure that required assurances, approvals, authorizations, and certifications (e.g., institutional review board [IRB] approvals, investigational new drug applications) are current and tracked centrally and at each site, as needed.
  • Assist study sites in addressing local IRB requirements regarding studywide procedures and materials.
  • If central or local IRBs do not have procedures for conducting multisite research, assist them with developing such procedures.
  • If a data and safety monitoring plan is required, develop processes for reporting required information to groups charged with study oversight.
  • If a data and safety monitoring board (DSMB) is required, identify DSMB members and develop a scope of work, consistent with funding agency guidelines.
  • Ensure that studywide systems to address serious adverse experiences and other safety issues meet IRB, funding agency, and governmental regulations.
  • Ensure that studywide procedures for handling of medications and biologic and hazardous materials are consistent with institutional and governmental regulatory and safety guidelines.

 

SUBJECT PARTICIPATION

Standardization

  • Develop clear studywide eligibility criteria and subject participation procedures that support diversity and appropriate population representation within the sample, protect sensitive patient information, and promote patient safety.
  • Develop procedures for subject recruitment, adherence, and retention that address site-specific strengths and challenges while incorporating studywide efficiencies.

Regulatory Compliance

  • Ensure that studywide procedures for informed consent and data confidentiality and security are consistent with institutional, human subject protection, and other governmental requirements.
  • Ensure that studywide tracking of sample diversity and its representation of the target population is consistent with institutional, funding agency, and governmental requirements.

 

DATA MANAGEMENT

Standardization

  • Ensure that study instruments and equipment are reliable, valid, and feasible for use across study sites.
  • Ensure that data management systems and databases support randomization, blinding and unblinding, stratification, crossover, and site-specific analyses.
  • Develop studywide data management systems that also proactively facilitate local operations (e.g., reports on upcoming visits and required tasks).
  • Develop studywide data management systems that facilitate evaluation of individual staff, each study site, and overall study performance (e.g., task completeness, timeliness).
  • Develop studywide systems to track each new version of a data collection instrument or database update, and incorporate (map) older versions to the current database.
  • Develop studywide methods for addressing missing data, preparing and cleaning data for analyses, and analyzing key variables.
  • Develop studywide systems for data sharing and tracking of data requests and releases.

Regulatory Compliance

  • Ensure that required progress reports and amendments are submitted to institutional, funding, and governmental regulatory groups.
  • Ensure that data systems address regulations regarding data security and storage and subject confidentiality.

 

FISCAL MANAGEMENT

Standardization

  • Negotiate with each site/subcontracting institution regarding a budget to establish a realistic and equitable scope of work, deliverables, and timelines that address the specific aims and cover the entire study.
  • Ensure that fiscal management systems support consistent tracking, reconciling, and projecting of site-specific and studywide budget expenditures.
  • Ensure that site expenditures are monitored in such a way that negotiated reimbursements are documented and justification is provided proactively for expenditures not included in the original budget.
  • Ensure that a system is in place for efficient reimbursement of participating institutions.
  • Ensure that any proposed studywide protocol or procedural changes address both local and central budgetary implications.

Regulatory Compliance

  • Ensure that subcontracts, budgets, and budget tracking and reporting procedures are consistent with institutional and funding agency requirements.

 

DISSEMINATION AND TRANSLATION

Standardization

  • Develop policies to support timely dissemination of study findings, including authorship, review of publication and presentation proposals, and access to data.
  • Develop policies to support ancillary or substudies, including investigator eligibility, review of study proposals, use of specimens, data access, and requirements for funding.
  • Develop policies, including budget implications during and after the study, for responding to outside requests for use of study data, materials, or products.
  • Develop model press releases and other communications to facilitate dissemination of study findings to the public, scientific community, and policy makers.

Regulatory Compliance

  • Develop policies for ensuring that investigators and authors of study publications and presentations have completed current conflict-of-interest forms.
  • Develop policies related to discoveries, copyrights, patents, and technology transfers that are consistent with the subcontract requirements of participating institutions.


REFERENCES

Office of Portfolio Analysis and Strategic Initiatives. (2006). NIH roadmap for medical research: Re-engineering the clinical research enterprise. Retrieved February 1, 2007, from http://nihroadmap.nih.gov/clinicalresearchtheme

Oncology Nursing Society. (2004). ONS role in multi-site research [Panel report]. Pittsburgh, PA: Author.

 

BIBLIOGRAPHY

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National Cancer Institute. (2005). Data and safety monitoring guidelines: Essential elements of a data and safety monitoring plan for clinical trials funded by the NCI. Retrieved February 1, 2007, from http://www.cancer.gov/clinicaltrials/conducting/dsm-guidelines

National Institute of Allergy and Infectious Diseases. (n.d.). Data and safety monitoring board SOP. Retrieved February 1, 2007, from http://www.niaid.nih.gov/ncn/sop/dsmb.htm

National Institutes of Health. (1998). NIH policy for data and safety monitoring. Retrieved February 2, 2007, from http://grants.nih.gov/grants/guide/notice-files/not98-084.html

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The ONS MultiSite Research Core Competencies Project Team

Volunteers

  • Barbara Cochrane, PhD, RN, FAAN, Team Leader
  • Victoria L. Champion, DNS, RN, FAAN
  • Rebecca Crane-Okada, PhD, RN, AOCN®
  • Victoria Mock, PhD, RN, FAAN
  • Joan G. Westendorp, MSN, RN, OCN®, CCRA

ONS Research Staff

  • Gail Mallory, PhD, RN, CNAA
  • Linda M. Lillington, DNSc, RN
  • Kelly Egnotovich

ONS Education Staff

  • Laura Fennimore, MSN, RN

 
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