GS-13 Critical Indicators

Protocol Compliance
  • Adheres to current regulations, guidance, and policies that affect research at the institutional, state, federal, and international levels.
  • Complies with the processes and procedures required by different types of sponsors (e.g., private industry, NCI Cancer Therapy Evaluation Program, investigator-initiated).
  • Ensures security of research data and personal health information.
  • Participates in discussions regarding feasibility of protocol implementation based on knowledge of institutional capabilities and limitations, therapy, or population of interest.
  • Collaborates with the research team to implement procedures for maintaining patient study participation from enrollment through completion.
  • Participates in providing timely, informative, and accurate communication to the IRB as required.
  • Facilitates and participates in the preparation for and implementation of scheduled and unscheduled meetings with external and internal monitors and auditors (e.g., sponsors, FDA, IRB, QA).
  • Ensures validity of research results by ensuring timely, accurate, and complete data documentation, reporting deviations, violations, and serious adverse events.
  • Collaborates with principal investigator, pharmacy, and other appropriate personnel to ensure proper use of and accountability for experimental devices or drugs as indicated.
Clinical Trials-Related Communication
  • Ensures ongoing formal and informal communication regarding clinical trials with team members.
  • Provides general clinical research as well as trial-specific information to research, clinical, and other organizational staff.
  • Develops relationships with referring physicians, clinical staff, and ancillary departments to facilitate compliance with and accrual to clinical trials.
  • Participates in study initiation meetings.
  • Provides education related to clinical trials to patients and their significant others.
  • Advocates for the safety and care of clinical trial patients as well as for the promotion and integrity of the clinical trial.
Informed Consent Process
  • Ensures the initial and ongoing consent process is performed and documented in compliance with FDA, International Conference on Harmonization Good Clinical Practice (GCP), institutional, sponsor, IRB, and other applicable regulations, guidances, and policies.
  • Participates in the education of clinical trial patients about their clinical trial and significant new information that is forthcoming during or after the conduct of the trial.
  • Assesses for barriers to effective informed consent discussions and implements plans to overcome them.
Management of Clinical Trial Patients
  • Collaborates with the investigator to ascertain study patient eligibility for a clinical trial, including documentation of criteria specified in the protocol.
  • Ensures adherence to the protocol schedule of events and other requirements.
  • Ensures scheduling of all procedures required to assess for adverse events and disease response to the study intervention.
  • Ensures the successful completion of correlative components of the clinical trial (e.g., pharmacokinetic, pharmacoeconomic, and quality-of-life studies).
  • Assesses patients for trial-related and non-trial-related symptoms and ensures evidence-based symptom management while maintaining trial compliance.
  • In collaboration with the investigator, assesses patients for adverse events and then documents and reports these findings per the protocol, sponsor, IRB, FDA, and OBA regulations.
  • Utilizes adverse event assessment data and clinical judgment to determine if a dose-limiting toxicity has occurred or if any treatment schedule or drug dose modifications are necessary and communicates findings to the study team and sponsors.
  • Evaluates disease response results and physical assessment data in conjunction with the principal investigator to determine response per the protocol.
  • Supports and evaluates patient adherence to the protocol by utilizing various methods to assist with documentation, patient education, and study agent return.
  • Identifies vulnerable patients who require increased nursing assessment and management in addition to the clinical trial requirements.
Documentation
  • Complies with regulations, institutional policies, and sponsor requirements governing source data and documentation.
  • Documents assessment, management, and evaluation in source documents for patients on clinical trials as appropriate to the protocol and role.
  • Educates research and clinical team members regarding appropriate and accurate source documentation for participants in clinical trials.
  • Ensures that relevant data from the source document are abstracted and recorded in the clinical trial case report forms and that every data point can be verified within the source document.
  • Follows appropriate guidelines in making corrections to data entry in clinical records and case report
    forms as recommended by good clinical practices, standards, or institutional procedures.
  • Ensures that all regulatory documents are processed and maintained per institution, IRB, and GCP.
  • Demonstrates proficiency in the use of clinical and research-related computer programs.
Patient Recruitment
  • Assists in implementation of recruitment plans to identify and assess individuals who might be eligible for clinical trials, taking into consideration the study entry criteria, required procedures, and other potential factors.
  • Identifies and develops processes to overcome barriers to recruitment related to patient demographic factors, underserved populations, and healthcare system influences.
  • Identifies institutional or community-based resources or groups that can assist in achieving recruitment goals.
Ethical Issues
  • Advocates for ethical care of clinical trial patients and the conduct of clinical trials in accordance with standards of nursing practice.
  • Promotes ongoing compliance with key ethical concepts by the research team, including informed consent, documentation, respect for persons, beneficence, and justice.
  • Ensures that members of vulnerable populations enrolled in clinical trials are identified and that their rights are addressed.
  • Identifies and follows institutional procedures to report any falsification of data or scientific misconduct.
Professional Development
  • Participates in educational opportunities to increase knowledge about clinical trials, regulations and guidance, and the role of the CTN.
  • Seeks resources on an ongoing basis that provide oncology treatment and nursing practice updates, such as through professional mentoring and meetings, journals, and Web sites.
Last updated by Fox, Susan (NIH/NCI) [E] on Oct 14, 2011