Handling Key Personnel

Key personnel for a research study are research personnel who are directly involved in conducting the research with human subjects through an interaction or intervention for research purposes (including participating in the consent process by either leading it or contributing to it), or who are directly involved with recording or processing identifiable private information (including protected health information) related to those subjects for the purpose of continuing the research study.  At Duke, the term "key personnel" is frequently associated with those that are listed in the eIRB.  This page describes the requirements, policies, and procedures for key personnel.

Duke Ways and Tools

The Principal Investigator

The status of Principal Investigator is a privilege provided to regular rank faculty in the university, select senior administrative staff in the university, all faculty in the medical center, and select senior administrative staff in the medical center. See the policy about who can act as a Principal Investigator at Duke for more information.

Roles and Responsibilities of the Principal Investigator for a sponsored project

According to the FDA Guidance for Industry: Investigator Responsibilities — Protecting the Rights, Safety, and Welfare of Study Subjects, October 2009, section B,2: Reasonable Access to Medical Care: “Investigators should be available to subjects during the conduct of the trial for medical care related to participation in the study. Availability is particularly important when subjects are receiving a drug that has significant toxicity or abuse potential. For example, if a study drug has potentially fatal toxicity, the investigator should be readily available by phone or other electronic communication 24 hours a day and in reasonably close proximity to study subjects (e.g., not in another state or on prolonged travel). Study subjects should be clearly educated on the possible need for such contact and on precisely how to obtain it, generally by providing pertinent phone numbers, e-mail addresses, and other contact information, in writing. Prior to undertaking the conduct of a study, prospective investigators should consider whether they can be available to the extent needed given the nature of the trial.”

Therefore, in the case that the PI no longer meets the criteria above (for example on prolonged travel), the study team must submit a personnel change request to change the PI to someone who is both knowledgeable and familiar with the study and can act as the PI in the former PI’s absence.

 

Key Personnel on a Study Team - Who Should and Should Not be Listed as Key Personnel in eIRB?

All research personnel who are directly involved in conducting the research with human subjects through an interaction or intervention for research purposes, or who are directly involved with recording or processing identifiable private information, including protected health information, related to those subjects for the purpose of conducting the research study should be listed as key personnel in eIRB.

You should list adjunct faculty members who are serving on a study in "Section 02. Study Personnel Outside Duke" in your eIRB submission.

Unpaid interns and volunteers who are 18 years of age or older, have a clean criminal background check, and complete the required Duke training may be added to a study team as key personnel.  These volunteers will not have access to a subject or patient's electronic medical record. See Duke's HR website for the Volunteer and Unpaid Intern Policy Guidelines. See the DUHS IRB website for specific instructions to add an unpaid intern or volunteer to study personnel.

An individual who is interacting with research subjects during the course of the study but only in his/her regular non-research employment capacity, such as a clinic receptionist, nurse or phlebotomist, or a radiologist or radiology technician, should NOT be listed as Key Personnel for the study.

 

Maintaining Key Personnel Lists in the eIRB

One of the most common audit findings is that key personnel are not maintained appropriately in eIRB. If an Investigator is not listed in the eIRB, this may be a study deviation that requires reporting to the IRB or, for studies with NIH support, a violation of grant agreements.

List all key personnel who are in the eIRB system before the individual starts working on the study.  Remove individuals from key personnel lists when they leave Duke or when they are no longer working on the study. Use the simple “Personnel Change Request” function in the eIRB to manage the Key Personnel list and keep it accurate.

 

Key Personnel Disclosure of Conflicts of Interest (COI) Related to Research

Conflicts of Interest related to research studies must be reported to the Duke University Ethics and Compliance Office each year and also as they occur throughout the year. Should key personnel have a significant change in any external financial relationships, update the Conflict of Interest Reporting Form within 30 days of the change in status. Examples of a “significant change” include new consulting relationships with a pharmaceutical or device company, a newly licensed intellectual property, or joining a scientific advisory board for a company that does business with Duke.  You must abide by the disclosure requirements of the COI Committee (as stated in your COI management plan) and the disclosure requirements of the IRB. Failure to comply may result in termination of the study or suspension of some study activities.

 

Required Training for All Study Team Members

Study team members are required to meet two training requirements specifically related to clinical research:

  • Human subjects protection training
  • Duke policy and procedures training

 

Human Subjects Protection Training

Duke uses the web-based modules available at the Collaborative Institutional Training Initiative (CITI) website to provide the required human subjects protection training. All employees who participate in the conduct of research with human subjects; and all Duke Medicine staff involved in the review, approval, or oversight of research involving human subjects must successfully complete this training.

Nine modules of the CITI training are required and a refresher course every two years. For personnel who conduct research at the Durham VA Medical Center, their CITI training may also meet the Duke requirement. If CITI modules have been completed at another institution, contact the Duke Office of Clinical Research to determine if the modules are applicable to Duke Medicine requirements. For additional information on Duke's requirements for CITI training, see the Duke University School of Medicine Human Subject Protection (HSP) Certification website. Ninety days prior to your expiration date, CITI will send you a reminder e-mail to renew your training. To logon and complete the CITI training modules or check your status, go to the CITI website at www.citiprogram.org. In the "Log in through my Institution" field, click the "Log in via SSO" button. Then, use your Duke Net ID and password to complete your training.

 

Duke Policy and Procedures Training

All Duke employees who are listed as key personnel with active protocols managed by the Duke Medicine Institutional Review Board (IRB) are required to successfully complete the Duke clinical research policy and procedures training. This annual requirement is met by the Duke Human Research Training (DHRT) course delivered in the Duke Learning Management System.

DOCR registers Key Personnel and other employees who support clinical research or have previously completed the training for the web-based version of Duke Human Research Training (DHRT) 30-45 days before annual expiration. The learner receives an automated notice from the Duke LMS of the registration. If the Key Personnel do not complete the training by 14 days before expiration and 7 days before expiration, DOCR sends the key personnel a reminder message.

 

Placement Health Review

All new employees working with patients with active illness, not healthy volunteers, are required to complete a placement health review with Employee Occupational Health and Wellness.

 

Packaging and Shipping Biological Specimens (i.e. lab kits)

Any person who is packaging and shipping biological specimens off the Duke campus (e.g. to a central lab) must complete the online “Shipping Biological Materials” training module provided by the Duke Occupational & Environmental Safety Office (OESO).  This is a Federal Aviation Administration (FAA) requirement.  FAA has been known to inspect sites for compliance with this regulation. 

 

Signature and Delegation of Authority Log

Certain study-related duties may be delegated by the Principal Investigator to qualified study research personnel. It is the responsibility of the investigator to ensure that the delegate is properly trained.  Keep a signed Delegation of Authority log for each study where the Principal Investigator has delegated any responsibilities. The following items may be delegated by Principal Investigators to qualified study staff: 

  • Development: Schedule of events, budget, billing grid
  • Informed Consent Process: development, obtaining consent
  • IRB: Communication, approval for subject enrollment, approval for changes in research, providing the Data Safety Monitoring Plan
  • Documentation: Maintaining accurate research records, completion of the CRFs, collection of adverse events
  • Subject: Recruitment, physical exams
  • Test Articles: Calculation of dosage, titration and prescription, dispensing investigational product, investigational product compliance and accountability
  • Sponsors: participating in negotiations
  • AEs, SAEs, Unanticipated Problems: determining causality, the relationship of the unanticipated problem to study participation, determining if the risk is new or increased

The following study-related duties MAY NOT be delegated and are the responsibility of the Principal Investigator:

  • Review case report forms and collected data
  • Ensure the study team is qualified by training, education, and experience
  • Sponsor-Investigators: Sponsor responsibilities

The Signature and Delegation of Authority Log lists both the key personnel on the study and identifies the responsibilities of the individual. List all key personnel and their responsibilities on the log before the individual starts performing the study tasks. Remove individuals from the log when they leave Duke or are no longer working on the study.

One of the most common audit findings is that key personnel are not maintained appropriately in eIRB or on the Signature and Delegation of Authority Log.

Training and Job Aids

 

DOCR Training

All DOCR training courses are available in the Duke LMS. For additional information, dates, and links to register, see the Available DOCR Training page.

  • Human Subjects Research at Duke
  • Adverse Events
  • Budget Development and Negotiation Training
  • ClinicalTrials.gov Introduction
  • Financial Basics for Clinical Research
  • Industry Funded Clinical Research
  • The Informed Consent Process
  • Investigator Responsibilities
  • IRB Overview
  • MC (Maestro Care) Clinical Research 100
  • MC (Maestro Care) Patient Verification and Financial Reconciliation
  • Phlebotomy Competency for Research
  • Phlebotomy RENEWAL Competency for Research
  • Recruiting Regulations and Best Practices
  • Research Data Integrity and Data Security
  • Research Data Security Plan
  • Research Database Design
  • Study Documentation: Regulations and Best Practices
  • Urine Pregnancy Screening Course
  • Workshop: ClinicalTrials.gov Practical Reporting
  • Workshop: ClinicalTrials.gov Advanced Reporting
  • Workshop: Creating SOPs
  • Workshop: Informed Consent Writing
  • Workshop: Consenting a Subject to a Research Study
Duke's Learning Management System

The Duke Learning Management System (LMS) is a tool that Duke uses to manage employee training. Duke's HR site includes a DIY video and additional job aids for how to use the LMS.

Research Wednesday Topic - The Duke LMS: What Can It Do for Me?
Dropping a Class
Finding and Printing Handouts
Finding and Printing Your Training Transcript
How to Find and Print a CEU Certificate
Printing a Training Transcript for Another Employee
Reviewing Online Content or Retaking a Quiz
Short User Guide
Troubleshooting
Using the Manager Dashboard

 

Duke's Research Professional's Network

Duke's Research Professional's Network is a group of researchers across the Duke University and Health System who work together to share information and support.  Almost 200 research professionals, spanning many CRUs and departments, have signed up to join the free network.  Benefits of joining include:

  • Free events to help you navigate research at Duke
  • In-service and training offerings so you can hone your research skills     
  • Opportunities for career growth, networking, and mentoring

For additional information, email docr-rpn@dm.duke.edu.

 

Investigator Training

Top Ten Investigator Responsibilities - (IRB)

 

Research Costing Compliance Training

Research Costing Compliance (RCC) offers a comprehensive portfolio of training classes and certificate programs in support of Research Administration at Duke University. RCC training is designed to provide instruction and best practices to the research administration community on federal rules and regulations as well as Duke policies and procedures regarding sponsored project management.

 

Safety Training

All employees are required to complete some safety training. However, the specifics differ by position and location. The Occupational & Environmental Safety Office sponsors safety training in their own online system.

 

Conflict of Interest

The Duke University Ethics and Compliance Office requires PIs to complete the COI form to disclose any possible conflicts of interest.

 

Biological Safety

The Biological Safety division of OESO addresses employee safety, training, policies and other concerns regarding occupational exposure to biological agents.

 

Maestro Care

Clinical research training in Maestro Care is available for all employees new to clinical research at Duke. The New to Duke: DOCR MC Clinical Research 100 course is required to receive clinical research access in Maestro Care. Employees can register for an available offering of this instructor-led class in the Duke LMS. Search for "DOCR MC" to view all available clinical research Maestro Care offerings.

Some employees only need to view the information in Maestro Care. For example, university employees may need to get access to work with DEDUCE. In this case, the employee can complete the MC Clinical Research - View Only online training and then submit a Service Now ticket to request access.

Maestro Care Access Requests via Support@Duke
Maestro Care Quick Start Guide for Clinical Research Coordinators
How to Log into the MC Playground (Maestro Care Clinical Research) Job Aid
Quick Tips Maestro Care Appointment Search for Research Coordinators (CADN55056) (Maestro Care Clinical Research)
Support at Duke Tip Sheet (Maestro Care Clinical Research)

Partner Resources

The Association of Clinical Research Professionals (ACRP)  is the primary resource for clinical research professionals in the pharmaceutical, biotechnology and medical device industries, and those in hospital, academic medical centers and physician office settings. ACRP's CCRC and CCRA certification exam programs are now accredited through the National Commission for Certifying Agencies (NCCA).

The Duke School of Medicine Clinical Research Training Program provides academic training in the quantitative and methodological principles of clinical research. Designed primarily for clinical fellows training for academic careers, the program's degree option leads to a Master of Health Sciences in Clinical Research awarded by Duke School of Medicine.

Model Agreements and Guidelines International (MAGI) is an organization that works to standardize best practices for clinical research operations, business, and regulatory compliance. MAGI holds regular clinical research conferences.

Regulatory Affairs Professionals Society (RAPS) is the leading worldwide member organization devoted to the health product regulatory profession. RAPS advances learning and fosters knowledge exchange in regulatory, scientific, business, legal and other areas essential to effective product development and regulation. RAPS also administers the only recognized credential specifically for regulatory professionals.

The Society of Clinical Research Associates (SOCRA) is a nonprofit professional organization dedicated to the continuing education and development of clinical research professionals. Its mission is to provide training, continuing education, and an internationally recognized certification program that promote quality clinical research to protect the welfare of research participants and improve global health.

The Society of Research Administrators (SRA) is the premier global research management society providing education, professional development and the latest comprehensive information about research management to 4,500 members from over 40 countries.

Computer Systems

 

Box

All active faculty, staff, students, and affiliates at Duke University and Duke Medicine will be automatically given a HIPAA-compliant Duke Box cloud-storage account. Users can access, share and collaborate on files (up to 50GB) securely with Duke and authorized non-Duke users. For additional information on Box and instructions for accessing the Using Box for Sensitive Data training, please visit the Box website.

 

Duke Enterprise Data Unified Content Explorer (DEDUCE)

DEDUCE is an online query interface enabling Duke investigators to search the clinical data stored in the Duke data warehouse. It can be used to generate a patient cohort and abstract data, using specific parameters or variables. DOCR RMT programmers are well-versed in DEDUCE and can assist investigators with writing and running queries.

 

eIRB

The IRB offers free one-on-one eIRB training to help study teams prepare protocol submissions. IRB staff will help you learn to navigate eIRB more efficiently, and to better understand the questions the IRB asks on eIRB submission forms. For a training session at a time convenient for you, please contact Minna Pak in the IRB.

 

Maestro Care

Training is regularly available for researchers who need to have clinical research access to the Maestro Care system. For most clinical research employees, the MC Clinical Research 100 course provides the foundation skills needed. This course requires that the learner complete an online prerequisite course - New to Duke: DOCR MC Clinical Research 100. Learners can register for the classes in the Duke LMS or attend the next available session.

 

Adding or Removing Team Members from Maestro Care

To add or delete personnel to or from a study protocol in Maestro Care, submit a Service Now ticket. Identify your issues as "Adding personnel to RSH record." The change in Maestro Care is independent of the key personnel change in the eIRB. There is no interface between eIRB and Maestro Care. All changes are completed manually. This process generally takes two business days.

 

REDCap

REDCap is a secure, web-based application for building and managing online databases and surveys. REDCap provides automated export procedures for seamless data downloads to Excel and common statistical packages (SPSS, SAS, Stata, R), as well as a built-in project calendar, a scheduling module, ad hoc reporting tools, and advanced features, such as branching logic, file uploading, and calculated fields. All collected information is stored on a standalone database server hosted by Duke Health Technology Services (DHTS). The database server resides behind the DHTS internal firewall and access to the server is controlled via firewall rules. All collected data is backed up daily, both on the local server and by the DHTS enterprise backup system. The REDCap website includes a brief training video, a request for an account, and a link to support.

Regulations and Guidance

Good Clinical Practice - (US FDA)

Disqualification of a Clinical Investigator  (FDA) - The U.S. Food and Drug Administration has amended its regulations on investigator disqualification. The new regulation provides guidance surrounding investigators who are ineligible to receive test articles, and the final rule is available.

Conflict of Interest - Sponsored Travel - Any individual who receives and/or is paid on a PHS-funded research grant is required to disclose all reimbursed or sponsored travel (i.e., that which is paid on behalf of the individual) taken on or after August 24, 2012 if the travel meets certain criteria. A Sponsored Travel FAQ is available online with further details about the new regulations.

International Conference on Harmonization Guidelines (ICH)

US Food and Drug Administration

DOCR attempts to maintain this information so that it is current and correct. However, DOCR does not own all the content referenced within this page or site. Therefore, links may change without prior knowledge. To report a broken link, please contact DOCR-Website@dm.duke.edu.