YALE CANCER CENTER CLINICAL TRIAL OFFICE
CLINICAL RESEARCH NURSE ORIENTATION
TRAINING & KEY ACCOUNTABILITIES CHECKLIST
Employee Name:
Date of Hire:
Training

Basic Training
Item






EPIC

Yale University Orientation
YCC CTO Mission and Strategic Plan
Review of Organizational Chart
TMS Training Assessment
o GCP
o HSPT
o HIPAA Privacy and Attestation
o HIPAA Security
o Other as directed by TMS
SOP Review (see SOP/Guidance document I:\STAFF\Training\CTO
Training Tracker)
o Clinical Trial Office Administration
o Protocol Development & Approval
o Study Activation
o Research Subject Management
o Data Management
o Study Closeout
o OnCore Work Instructions
o Quality Assurance & Control
o Conduct of Clinical Trials
Ambulatory Oncology CS 100 & 200
Completion date
Employee/Supervisor
Initials
YALE CANCER CENTER CLINICAL TRIAL OFFICE
CLINICAL RESEARCH NURSE ORIENTATION
TRAINING & KEY ACCOUNTABILITIES CHECKLIST
Employee Name:
Date of Hire:



Access,
Navigation
Use



Diagnosis
Staging
Treatment modalities
ONS
Chemotherapy/Bio
therapy
Certification
Course




Administration
Side effect management,
Extravasation management
Safe handling

Clinical



EKG training
Venipuncture training/certification (optional)
CPR

Basic
Pharmacology



ADME
PK/PD
Medication Exam
o score

I-Drive

Oncology
Fundamentals
Course

YALE CANCER CENTER CLINICAL TRIAL OFFICE
CLINICAL RESEARCH NURSE ORIENTATION
TRAINING & KEY ACCOUNTABILITIES CHECKLIST
Employee Name:
Date of Hire:

Personalized
Medicine



Molecular biology of cancer
Biomarker development
Drug development

Clinical Research
Fundamentals


Types and phases of clinical research
The clinical research protocol-key elements
o Inclusion/exclusion-determining eligibility
o Visit schedules/ windows
The informed consent-key elements
Roles and responsibilities of the clinical research team
o PI
o CTO staff-PM, DM, RA, CTA
o CRSL
o Research Pharmacy
o Associated Diagnostic Imaging staff
o Contracts and Budgeting
Roles and responsibilities of the sponsor
o Regulatory
o Clinical Trial Medical Monitor
o Site Monitor
o Site selection
Regulatory considerations-IRB





Regulatory

FDA
o
o
1572
DOA
YALE CANCER CENTER CLINICAL TRIAL OFFICE
CLINICAL RESEARCH NURSE ORIENTATION
TRAINING & KEY ACCOUNTABILITIES CHECKLIST
Employee Name:
Date of Hire:

Study Activities





IRB
HIPAA
Audits
Drug Accountability
SOP



Site Activation
IVRS
Mandatory training for clinical research staff and clinical staff
o SIV
o Clinical Nurse Education
Prescreening
Informed consent
Screening
Eligibility
Enrollment/Registration
Protocol Playbook and Forms
Source documentation
CRF
Queries
Toxicity Assessment and the CTCAE
Definition and reporting of SAEs
Concomitant medication documentation
Drug accountability
Laboratory and specimen collection
Key subject evaluation forms















YALE CANCER CENTER CLINICAL TRIAL OFFICE
CLINICAL RESEARCH NURSE ORIENTATION
TRAINING & KEY ACCOUNTABILITIES CHECKLIST
Employee Name:
Date of Hire:

Interdisciplinary
Communication





Daily CRN(s)-CTA(s) huddle
Weekly disease team meeting
Weekly schedules-treatment schedule review
Tumor Board
Treatment Team/Clinical Staff
o EPIC order association communication, CRN medication
verification and documentation
o Verbal communication with treating investigator
o Verbal and written handoff to infusion nurse
o CRN-Pharmacy
o CRN-CRSL

OnCore


Subject Administration
CTA
 New Subject Registration
 Demographics
 Consent
CRN
 Eligibility
 On Study
 Treatment
 SAE
 Deviation
 Other

YALE CANCER CENTER CLINICAL TRIAL OFFICE
CLINICAL RESEARCH NURSE ORIENTATION
TRAINING & KEY ACCOUNTABILITIES CHECKLIST
Employee Name:
Date of Hire:

Shadow
Experience
Areas requiring
additional training or
special consideration









PI
APP
Infusion RN
CRSL
Research Pharmacist
PM
DM
CTA
Other as directed

Radiation Oncology
To be developed

Pediatric Oncology
To be developed

Phase I
YALE CANCER CENTER CLINICAL TRIAL OFFICE
CLINICAL RESEARCH NURSE ORIENTATION
TRAINING & KEY ACCOUNTABILITIES CHECKLIST
Employee Name:
Date of Hire:
To be developed
Demonstration of Key
Activities,
Accountabilities &
Competencies
Activity/Measurement Criteria
Comments:
*Must be conducted in accordance with specific protocol,
university/hospital, and federal regulations.
U-Unsatisfactory
NI-Needs
Improvement
ME-Meets
Expectation
Protocol Management
& Compliance

Prescreens patient and communicates information to treating
investigator

Obtains Informed Consent and documents appropriately

Coordinates screening and documents appropriately

Creates an Eligibility worksheet

Determines eligibility with 2nd RN review and obtains treating
investigator verification and documents appropriately

Enrolls/Registers/Randomizes patient (IVRS) and documents
appropriately

Provides Patient Education regarding:
o clinical trial participation
o schedule and treatment
Conduct of Research
Date/Preceptor
initials
YALE CANCER CENTER CLINICAL TRIAL OFFICE
CLINICAL RESEARCH NURSE ORIENTATION
TRAINING & KEY ACCOUNTABILITIES CHECKLIST
Employee Name:
Date of Hire:
o
o
o
o
medication administration
safe handling of oral chemotherapy
key contact information
documents appropriately

Pre-treatment:
o Confirms HIC order entry prior to treatment.
o Verifies study medication and other orders.
o Reviews
 Labs
 EKG
 Concomitant medication list,
 Toxicity assessment (uses the CTCAE to grade AE)
with treating investigator.
o Confirms that patient meets criteria for treatment per
protocol or ensures that dose modification or
discontinuation occurs per protocol.
o Communicates with Research Pharmacy and CRSL regarding
treatment plan in a timely manner.
o Completes EPIC documentation-in basket message,
progress note, other in a timely manner
o Provides verbal and written handoff to clinical/infusion
nurse.
o Provides pill diary to patient if needed
o Verifies oral study medication with 2nd RN.
o Documents pill count in progress note.
o Ensures drug accountability with Research Pharmacist.

Develops Quick Sheet for Beacon Protocol Template Build with CRSL
YALE CANCER CENTER CLINICAL TRIAL OFFICE
CLINICAL RESEARCH NURSE ORIENTATION
TRAINING & KEY ACCOUNTABILITIES CHECKLIST
Employee Name:
Date of Hire:
input after PRC review
Disease Team
Communication and
Participation

Develops Protocol Worksheets per the Playbook for HIC review


Reports AEs to PI, sponsor and other research members
Completes SAE submission within 24 hours of notification.

Responds and completes query response in a timely manner

Completes OnCore Documentation within 24 hours
o Eligibility
o Treatment
o SAE
o Deviation

Clinical Staff Education
o Develops slide set for clinical staff education
o Provides clinical education to ambulatory infusion staff
and/or care center staff
o
o
o
o
Actively participates in Disease Team Meetings
Serves as the primary medical person to interpret the
protocol to medical and nursing staff, particularly related to
dose, concomitant medications, and safety issues related to
the administration of the study drug or treatment.
Communicates with CRSL, Research Pharmacy, treating
providers, clinical nursing, and others to ensure an
excellent patient experience.
Coordinates data collections and assist in preparing data for
YALE CANCER CENTER CLINICAL TRIAL OFFICE
CLINICAL RESEARCH NURSE ORIENTATION
TRAINING & KEY ACCOUNTABILITIES CHECKLIST
Employee Name:
Date of Hire:
o
Nursing Team
Participation
Professional
Accountability
Professional
Development



Demonstrates willingness to assist CTO colleagues, including other
disease team CRNs, with workload, education, and training.
Identifies professional development plan with specific goals and
timeline. Re-evaluates at least every six months (January and June)
Obtains professional certification.
Employee Signature
Date
Preceptor/Mentor Signature
Date
Supervisor Signature
Date:
4/26/13
kkr
entry into sponsor data base for analysis.
Assists with the preparation of documents for audit and
review by sponsors, regulatory agencies, and internal and
external review boards.